Trial · NCT01337089

Long Term Safety of Sativex Oromucosal Spray (Sativex®; Nabiximols) as Adjunctive Therapy in Patients With Uncontrolled Persistent Chronic Cancer Related Pain

NCT01337089, Phase 3, Completed, Jazz Pharmaceuticals; results first posted 2018-04-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Long Term Safety of Sativex Oromucosal Spray (Sativex®; Nabiximols) as Adjunctive Therapy in Patients With Uncontrolled Persistent Chronic Cancer Related Pain. Trials, record NCT01337089. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01337089

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Long Term Safety of Sativex Oromucosal Spray (Sativex®; Nabiximols) as Adjunctive Therapy in Patients With Uncontrolled Persistent Chronic Cancer Related Pain
NCT number: NCT01337089
Status: Completed
Phases: Phase 3
Enrollment: 660 participants, actual
Lead sponsor: Jazz Pharmaceuticals
Conditions: Pain, Advanced Cancer
Interventions: Nabiximols
First posted: 2011-04-18
Last updated: 2023-04-12
Other registries' IDs: eudract:2009-016529-32
Results first posted: 2018-04-23

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percent Of Participants With Treatment-emergent Adverse Events	Baseline, Day 183	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.
Secondary	Change From Baseline In Mean NRS Average Pain During The Last Period	Baseline, Last Period (Days 156-183) or last 27 days of treatment	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.
Secondary	Change From Baseline In Mean Sleep Disruption NRS During The Last Period	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.
Secondary	Patient Satisfaction Questionnaire At Last Visit (Up To Day 183)	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.
Secondary	Change From Baseline In NRS Constipation At Last Visit (Up To Day 183)	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.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percent Of Participants With Treatment-emergent Adverse Events	Baseline, Day 183	The Safety Population included all participants receiving at least 1 dose of study drug.	percent of participants	NUMBER
SECONDARY	Change From Baseline In Mean NRS Average Pain During The Last Period	Baseline, Last Period (Days 156-183) or last 27 days of treatment	The Safety Population included all participants receiving at least 1 dose of study drug.	units on a scale	MEAN
SECONDARY	Change From Baseline In Mean Sleep Disruption NRS During The Last Period	Baseline, Last Period (Days 156-183) or last 27 days of treatment	The Safety Population included all participants receiving at least 1 dose of study drug.	units on a scale	MEAN
SECONDARY	Patient Satisfaction Questionnaire At Last Visit (Up To Day 183)	Last Visit (up to Day 183)	The Safety Population included all participants receiving at least 1 dose of study drug.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change From Baseline In NRS Constipation At Last Visit (Up To Day 183)	Baseline, Last Visit (up to Day 183)	The Safety Population included all participants receiving at least 1 dose of study drug.	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group11

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Percent Of Participants With Treatment-emergent Adverse Events	Nabiximols		82.9		percent of participants
Change From Baseline In Mean NRS Average Pain During The Last Period	Nabiximols		0.0	Standard Deviation 1.8	units on a scale
Change From Baseline In Mean Sleep Disruption NRS During The Last Period	Nabiximols		0.1	Standard Deviation 1.9	units on a scale
Patient Satisfaction Questionnaire At Last Visit (Up To Day 183)	Nabiximols	Extremely Satisfied	56		Participants
Patient Satisfaction Questionnaire At Last Visit (Up To Day 183)	Nabiximols	Very Satisfied	230		Participants
Patient Satisfaction Questionnaire At Last Visit (Up To Day 183)	Nabiximols	Slightly Satisfied	185		Participants
Patient Satisfaction Questionnaire At Last Visit (Up To Day 183)	Nabiximols	Neutral	82		Participants
Patient Satisfaction Questionnaire At Last Visit (Up To Day 183)	Nabiximols	Slightly Dissatisfied	33		Participants
Patient Satisfaction Questionnaire At Last Visit (Up To Day 183)	Nabiximols	Very Dissatisfied	22		Participants
Patient Satisfaction Questionnaire At Last Visit (Up To Day 183)	Nabiximols	Extremely Dissatisfied	10		Participants

1 to 10 of 11Source ClinicalTrials.gov

See all 11 results by group

Participant flow6

How many started, completed or left each group, period by period.

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

Source ClinicalTrials.gov

Adverse events139

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anaemia	Blood and lymphatic system disorders	Nabiximols	39	660
other	Nausea	Gastrointestinal disorders	Nabiximols	86	660
other	Vomiting	Gastrointestinal disorders	Nabiximols	59	660
other	Constipation	Gastrointestinal disorders	Nabiximols	44	660
other	Diarrhoea	Gastrointestinal disorders	Nabiximols	41	660
other	Fatigue	General disorders	Nabiximols	35	660
other	Decreased Appetite	Metabolism and nutrition disorders	Nabiximols	49	660
other	Neoplasm Progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Nabiximols	41	660
other	Dizziness	Nervous system disorders	Nabiximols	51	660
other	Somnolence	Nervous system disorders	Nabiximols	38	660

1 to 10 of 139Source ClinicalTrials.gov

See all 139 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Nabiximols
Total, other adverse events	Nabiximols	291	660
Total, serious adverse events	Nabiximols	301	660

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01337089

GET https://conductscience.org/api/trials/v1/NCT01337089/events?page=2

API reference For AI assistants