INTERVENTIONALCOMPLETEDNCT01337089

A Multicenter, Non-comparative, Open-label Extension Study to Assess the Long Term Safety of Sativex® Oromucosal Spray (Sativex®; Nabiximols) as Adjunctive Therapy in Patients With Uncontrolled Persistent Chronic Cancer Related Pain

This was a six-month open-label extension (OLE) study to evaluate the safety of long-term nabiximols (Sativex®) therapy when used as an adjunctive treatment in participants with advanced cancer. The study provided continued availability of nabiximols to participants who completed a preceding Phase 3 study and new (de novo) participants.

Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2023-04-12

What this record can show

Registry results are available

Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.

Registry facts

Study at a glance

Phase: PHASE3
Enrollment: 660 (ACTUAL)
Start date: 2011-01-19
Sponsor: Jazz Pharmaceuticals
Design: NA · SINGLE GROUP · TREATMENT
Locations: 128
Results record: Present in registry snapshot

This was a 6-month, multicenter, non-comparative, OLE study to evaluate the safety of long-term nabiximols use as an adjunctive measure in participants with advanced cancer. The study provided continued availability of nabiximols to participants who completed a preceding double-blind phase 3 study and de novo participants. Consenting eligible participants entered the extension study (Day 1) on the same day as the "end of treatment" visit of a parent study or within 7 days of the "end of treatment" visit or on the day of the "safety follow-up visit" of the parent study. The "safety follow-up" visit of a parent study was performed on the same day as Day 1, if the participant did not enter the OLE study on the same day as the "end of treatment" visit of a parent study. De novo participants attended a screening visit 3 to 14 days prior to enrollment (Day 1). All participants commenced dosing on Day 1. Further study visits took place after 2 weeks (Day 15), and every 4 weeks thereafter until the end of treatment period on Day 183 or earlier if the participant withdrew from the study. Treatment was started as a single spray in the evening on the first day (Day 1). Participants then gradually titrated by 1 additional spray per day to an individualized dose, balancing efficacy and tolerability. Participants had to complete titration within 14 days of their first dose of study drug and then continue at the same dose for the remainder of the study.

Linked local records

Related local records

Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.

Conditions

Cancer Pain

Cannabinoids and active compounds

No governed compound link was found.

Medicines

SATIVEX

Interventions

What was registered

DRUG

Nabiximols

Sativex®

Source-reported results

Results posted to the registry

5 outcomes

Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.

Primary outcomes: 1
Secondary outcomes: 4
Statistical analyses: 0
Adverse-event terms: 139

PRIMARYPercent Of Participants With Treatment-emergent Adverse Events

Time frame: Baseline, Day 183
Measure: NUMBER · percent of participants
Reporting status: POSTED

Treatment-emergent Adverse Events (TEAEs) were coded according to the Medical Dictionary for Regulatory Activities (MedDRA) dictionary version 17.0. A TEAE is defined as an adverse event with an onset after the start of study drug treatment. The percent of participants who experienced one or more TEAEs is reported.

Population: The Safety Population included all participants receiving at least 1 dose of study drug.

Group	N	Value	Spread / interval
Nabiximols	660	82.9	-

SECONDARYChange From Baseline In Mean NRS Average Pain During The Last Period

Time frame: Baseline, Last Period (Days 156-183) or last 27 days of treatment
Measure: MEAN · units on a scale
Reporting status: POSTED

Participants indicated the level of pain experienced in the last 24 hours on an 11-point Numerical Rating Scale (NRS), where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine." Change in mean NRS average pain was calculated as: Last Period NRS average pain score - Baseline NRS average pain score. A negative value indicates an improvement in average pain score from Baseline.

Population: The Safety Population included all participants receiving at least 1 dose of study drug.

Eligibility

Population and criteria

Sex: ALL
Minimum age: 18 Years
Maximum age: Not reported
Healthy volunteers: Not accepted

Inclusion criteria

Participant had completed the parent study within the last seven days
Willing and able to give written informed consent
Willing and able to comply with all study requirements

Exclusion criteria

The participant was using cannabis or cannabinoid based medications, other than the parent study investigational medicinal product (IMP), and was unwilling to abstain for the duration of the study
Any history or immediate family history of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition
Any known or suspected history of a substance abuse/dependence disorder (including opiate abuse/dependence prior to the diagnosis of cancer), current heavy alcohol consumption (more than 60 grams \[g\] of pure alcohol per day for men, and more than 40 g of pure alcohol per day for women), current use of an illicit drug or current non-prescribed use of any prescription drug
Had poorly controlled epilepsy or recurrent seizures (for example, one or more seizure during the last year)
Had experienced myocardial infarction or clinically significant cardiac dysfunction within the last 12 months or had a cardiac disorder that, in the opinion of the investigator would have put the participant at risk of a clinically significant arrhythmia or myocardial infarction
Had significantly impaired renal function
Had significantly impaired hepatic function at the "end of treatment" visit of the parent study
Female participants of child-bearing potential and male participants whose partner was of child-bearing potential, unless willing to ensure that they or their partner used effective contraception, for example, oral contraception, double barrier, intra-uterine device, during the study and for 3 months thereafter (however, a male condom should not have been used in conjunction with a female condom as this may not have proven effective)

primary outcomes

primary measures

Percent Of Participants With Treatment-emergent Adverse Events

Time frame: Baseline, Day 183

secondary outcomes

secondary measures

Change From Baseline In Mean NRS Average Pain During The Last Period

Time frame: Baseline, Last Period (Days 156-183) or last 27 days of treatment

Change From Baseline In Mean Sleep Disruption NRS During The Last Period

Time frame: Baseline, Last Period (Days 156-183) or last 27 days of treatment

Participants indicated the level of sleep disruption experienced in the last 24 hours on an 11-point NRS, where a score of 0 indicated "did not disrupt sleep" and a score of 10 indicated "completely disrupted (unable to sleep at all)." Change in mean sleep disruption NRS was calculated as: Last Period sleep disruption NRS score - Baseline sleep disruption NRS score. A negative value indicates an improvement in sleep disruption score from Baseline.

Patient Satisfaction Questionnaire At Last Visit (Up To Day 183)

Time frame: Last Visit (up to Day 183)

The Patient Satisfaction Questionnaire (PSQ) was used to assess level of satisfaction of the participant with the study drug, with the markers "extremely satisfied, very satisfied, slightly satisfied, neutral, slightly dissatisfied, very dissatisfied, extremely dissatisfied". Last visit refers to the last visit that a participant completed the assessment.

Change From Baseline In NRS Constipation At Last Visit (Up To Day 183)

Time frame: Baseline, Last Visit (up to Day 183)

Participants indicated level of constipation on an 11-point NRS, where a score of 0 was "no constipation", and 10 was "constipation as bad as you can imagine." Last visit refers to the last visit that a participant completed the assessment. Change in NRS constipation score was calculated as: Last Visit NRS constipation score - Baseline NRS constipation score. A negative value indicates improvement in condition from Baseline.

Publications

Locally readable linked articles

No exact PMID-linked public article is currently readable locally.

Snapshot provenance

Snapshot: aa609d42-0882-44e0-8369-7da46fae1a59
Retrieved: 11/09/2026, 14:16:52
SHA-256: 3a400b231888e7aa7333174b81f2a0781c00b6b172040ba5acb98d50fda264e4

Group	N	Value	Spread / interval
Nabiximols · Extremely Satisfied	618	56	-
Nabiximols · Very Satisfied	618	230	-
Nabiximols · Slightly Satisfied	618	185	-
Nabiximols · Neutral	618	82	-
Nabiximols · Slightly Dissatisfied	618	33	-
Nabiximols · Very Dissatisfied	618	22	-
Nabiximols · Extremely Dissatisfied	618	10	-

Event	System	Groups: affected / at risk
Anaemia	Blood and lymphatic system disorders	Nabiximols: 8 / 660
Anaemia Of Malignant Disease	Blood and lymphatic system disorders	Nabiximols: 1 / 660
Febrile Neutropenia	Blood and lymphatic system disorders	Nabiximols: 1 / 660
Neutropenia	Blood and lymphatic system disorders	Nabiximols: 1 / 660
Angina Pectoris	Cardiac disorders	Nabiximols: 1 / 660
Atrial Fibrillation	Cardiac disorders	Nabiximols: 1 / 660
Cardiopulmonary Failure	Cardiac disorders	Nabiximols: 1 / 660
Myocardial Infarction	Cardiac disorders	Nabiximols: 3 / 660
Pyloric Stenosis	Congenital, familial and genetic disorders	Nabiximols: 1 / 660
Deafness Neurosensory	Ear and labyrinth disorders	Nabiximols: 1 / 660
Vertigo	Ear and labyrinth disorders	Nabiximols: 1 / 660
Adrenal Insufficiency	Endocrine disorders	Nabiximols: 1 / 660
Blindness	Eye disorders	Nabiximols: 1 / 660
Nausea	Gastrointestinal disorders	Nabiximols: 6 / 660
Vomiting	Gastrointestinal disorders	Nabiximols: 7 / 660
Abdominal Pain	Gastrointestinal disorders	Nabiximols: 4 / 660
Abdominal Pain Upper	Gastrointestinal disorders	Nabiximols: 1 / 660
Gastritis	Gastrointestinal disorders	Nabiximols: 1 / 660
Gastritis Erosive	Gastrointestinal disorders	Nabiximols: 1 / 660
Haematemesis	Gastrointestinal disorders	Nabiximols: 1 / 660
Ileus	Gastrointestinal disorders	Nabiximols: 2 / 660
Intestinal Obstruction	Gastrointestinal disorders	Nabiximols: 1 / 660
Mechanical Ileus	Gastrointestinal disorders	Nabiximols: 1 / 660
Proctalgia	Gastrointestinal disorders	Nabiximols: 1 / 660
Small Intestinal Obstruction	Gastrointestinal disorders	Nabiximols: 2 / 660
Tongue Haemorrhage	Gastrointestinal disorders	Nabiximols: 1 / 660
Chest Pain	General disorders	Nabiximols: 4 / 660
Device Occlusion	General disorders	Nabiximols: 1 / 660
General Physical Health Deterioration	General disorders	Nabiximols: 1 / 660
Local Swelling	General disorders	Nabiximols: 1 / 660
Pain	General disorders	Nabiximols: 6 / 660
Pyrexia	General disorders	Nabiximols: 3 / 660
Gastroenteritis	Infections and infestations	Nabiximols: 2 / 660
Urinary Tract Infection	Infections and infestations	Nabiximols: 1 / 660
Bacteraemia	Infections and infestations	Nabiximols: 1 / 660
Bronchitis	Infections and infestations	Nabiximols: 1 / 660
Catheter Site Infection	Infections and infestations	Nabiximols: 1 / 660
Cellulitis	Infections and infestations	Nabiximols: 2 / 660
Clostridium Difficile Colitis	Infections and infestations	Nabiximols: 1 / 660
Diverticulitis	Infections and infestations	Nabiximols: 1 / 660
Herpes Zoster	Infections and infestations	Nabiximols: 1 / 660
Klebsiella Sepsis	Infections and infestations	Nabiximols: 1 / 660
Lobar Pneumonia	Infections and infestations	Nabiximols: 1 / 660
Lower Respiratory Tract Infection	Infections and infestations	Nabiximols: 4 / 660
Pelvic Abscess	Infections and infestations	Nabiximols: 1 / 660
Pneumonia	Infections and infestations	Nabiximols: 6 / 660
Pseudomembranous Colitis	Infections and infestations	Nabiximols: 1 / 660
Respiratory Tract Infection	Infections and infestations	Nabiximols: 1 / 660
Sepsis	Infections and infestations	Nabiximols: 3 / 660
Sinusitis	Infections and infestations	Nabiximols: 1 / 660
Staphylococcal Bacteraemia	Infections and infestations	Nabiximols: 1 / 660
Staphylococcal Sepsis	Infections and infestations	Nabiximols: 1 / 660
Subacute Endocarditis	Infections and infestations	Nabiximols: 1 / 660
Viral Infection	Infections and infestations	Nabiximols: 1 / 660
Accidental Overdose	Injury, poisoning and procedural complications	Nabiximols: 1 / 660
Fall	Injury, poisoning and procedural complications	Nabiximols: 5 / 660
Femur Fracture	Injury, poisoning and procedural complications	Nabiximols: 1 / 660
Gastrointestinal Stoma Complication	Injury, poisoning and procedural complications	Nabiximols: 1 / 660
Joint Dislocation	Injury, poisoning and procedural complications	Nabiximols: 1 / 660
Procedural Headache	Injury, poisoning and procedural complications	Nabiximols: 2 / 660
Radiation Oesophagitis	Injury, poisoning and procedural complications	Nabiximols: 1 / 660
Shunt Occlusion	Injury, poisoning and procedural complications	Nabiximols: 1 / 660
Stoma Complication	Injury, poisoning and procedural complications	Nabiximols: 1 / 660
Cachexia	Metabolism and nutrition disorders	Nabiximols: 1 / 660
Dehydration	Metabolism and nutrition disorders	Nabiximols: 4 / 660
Diabetes Mellitus	Metabolism and nutrition disorders	Nabiximols: 1 / 660
Hypokalaemia	Metabolism and nutrition disorders	Nabiximols: 1 / 660
Hyponatraemia	Metabolism and nutrition disorders	Nabiximols: 1 / 660
Arthralgia	Musculoskeletal and connective tissue disorders	Nabiximols: 1 / 660
Back Pain	Musculoskeletal and connective tissue disorders	Nabiximols: 2 / 660
Muscular Weakness	Musculoskeletal and connective tissue disorders	Nabiximols: 1 / 660
Osteonecrosis	Musculoskeletal and connective tissue disorders	Nabiximols: 1 / 660
Pathological Fracture	Musculoskeletal and connective tissue disorders	Nabiximols: 4 / 660
Neoplasm Progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Nabiximols: 209 / 660
Breast Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Nabiximols: 1 / 660
Cancer Pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Nabiximols: 4 / 660
Lung Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Nabiximols: 1 / 660
Lung Neoplasm Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Nabiximols: 1 / 660
Metastases To Bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Nabiximols: 1 / 660
Metastases To Central Nervous System	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Nabiximols: 3 / 660
Metastases To Liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Nabiximols: 1 / 660
Metastases To Spine	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Nabiximols: 1 / 660
Metastatic Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Nabiximols: 1 / 660
Ovarian Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Nabiximols: 1 / 313
Plasma Cell Myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Nabiximols: 2 / 660
Squamous Cell Carcinoma Of Skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Nabiximols: 1 / 660
Tumour Haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Nabiximols: 1 / 660
Spinal Cord Compression	Nervous system disorders	Nabiximols: 3 / 660
Altered State Of Consciousness	Nervous system disorders	Nabiximols: 1 / 660
Balance Disorder	Nervous system disorders	Nabiximols: 1 / 660
Carotid Artery Stenosis	Nervous system disorders	Nabiximols: 1 / 660
Cerebral Infarction	Nervous system disorders	Nabiximols: 1 / 660
Cerebrovascular Accident	Nervous system disorders	Nabiximols: 3 / 660
Grand Mal Convulsion	Nervous system disorders	Nabiximols: 1 / 660
Dementia With Lewy Bodies	Nervous system disorders	Nabiximols: 1 / 660
Dizziness	Nervous system disorders	Nabiximols: 2 / 660
Encephalopathy	Nervous system disorders	Nabiximols: 1 / 660
Epilepsy	Nervous system disorders	Nabiximols: 1 / 660
Posterior Reversible Encephalopathy Syndrome	Nervous system disorders	Nabiximols: 2 / 660
Syncope	Nervous system disorders	Nabiximols: 1 / 660
Tremor	Nervous system disorders	Nabiximols: 1 / 660
Agitation	Psychiatric disorders	Nabiximols: 1 / 660
Completed Suicide	Psychiatric disorders	Nabiximols: 1 / 660
Depression	Psychiatric disorders	Nabiximols: 1 / 660
Disorientation	Psychiatric disorders	Nabiximols: 4 / 660
Mental Status Changes	Psychiatric disorders	Nabiximols: 2 / 660
Suicide Attempt	Psychiatric disorders	Nabiximols: 1 / 660
Renal Failure Acute	Renal and urinary disorders	Nabiximols: 1 / 660
Urinary Retention	Renal and urinary disorders	Nabiximols: 5 / 660
Urinary Tract Obstruction	Renal and urinary disorders	Nabiximols: 1 / 660
Genital Haemorrhage	Reproductive system and breast disorders	Nabiximols: 1 / 660
Vaginal Fistula	Reproductive system and breast disorders	Nabiximols: 1 / 313
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Nabiximols: 5 / 660
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	Nabiximols: 3 / 660
Hypoxia	Respiratory, thoracic and mediastinal disorders	Nabiximols: 1 / 660
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	Nabiximols: 2 / 660
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	Nabiximols: 1 / 660
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	Nabiximols: 3 / 660
Acute Febrile Neutrophilic Dermatosis	Skin and subcutaneous tissue disorders	Nabiximols: 1 / 660
Dry Gangrene	Skin and subcutaneous tissue disorders	Nabiximols: 1 / 660
Deep Vein Thrombosis	Vascular disorders	Nabiximols: 4 / 660
Haemorrhage	Vascular disorders	Nabiximols: 1 / 660
Hypertension	Vascular disorders	Nabiximols: 1 / 660
Hypotension	Vascular disorders	Nabiximols: 1 / 660
Inferior Vena Caval Occlusion	Vascular disorders	Nabiximols: 1 / 660
Venous Thrombosis Limb	Vascular disorders	Nabiximols: 1 / 660
Convulsion	Nervous system disorders	Nabiximols: 2 / 660

Event	System	Groups: affected / at risk
Anaemia	Blood and lymphatic system disorders	Nabiximols: 39 / 660
Nausea	Gastrointestinal disorders	Nabiximols: 86 / 660
Vomiting	Gastrointestinal disorders	Nabiximols: 59 / 660
Constipation	Gastrointestinal disorders	Nabiximols: 44 / 660
Diarrhoea	Gastrointestinal disorders	Nabiximols: 41 / 660
Fatigue	General disorders	Nabiximols: 35 / 660
Decreased Appetite	Metabolism and nutrition disorders	Nabiximols: 49 / 660
Neoplasm Progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Nabiximols: 41 / 660
Dizziness	Nervous system disorders	Nabiximols: 51 / 660
Somnolence	Nervous system disorders	Nabiximols: 38 / 660
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Nabiximols: 37 / 660
Asthenia	General disorders	Nabiximols: 50 / 660

A Multicenter, Non-comparative, Open-label Extension Study to Assess the Long Term Safety of Sativex® Oromucosal Spray (Sativex®; Nabiximols) as Adjunctive Therapy in Patients With Uncontrolled Persistent Chronic Cancer Related Pain

Registry results are available

Study at a glance

Related local records

Conditions

Cannabinoids and active compounds

Medicines

What was registered

Nabiximols

Results posted to the registry

Population and criteria

Inclusion criteria

Exclusion criteria

primary measures

Percent Of Participants With Treatment-emergent Adverse Events

secondary measures

Change From Baseline In Mean NRS Average Pain During The Last Period

Change From Baseline In Mean Sleep Disruption NRS During The Last Period

Patient Satisfaction Questionnaire At Last Visit (Up To Day 183)

Change From Baseline In NRS Constipation At Last Visit (Up To Day 183)

Locally readable linked articles

Overall Study

Age, Continuous

Sex: Female, Male

Nabiximols

Milestone	Nabiximols
STARTED	660
Received at Least 1 Dose of Study Drug	660
Safety Population	660
Efficacy Dataset	659
COMPLETED	256
NOT COMPLETED	404