Trial · NCT00674609

A Study of Sativex® for Pain Relief in Patients With Advanced Malignancy

NCT00674609, Phase 3, Completed, Jazz Pharmaceuticals; results first posted 2012-08-13

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Study of Sativex® for Pain Relief in Patients With Advanced Malignancy. Trials, record NCT00674609. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00674609

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Trial

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

Title: A Study of Sativex® for Pain Relief in Patients With Advanced Malignancy
NCT number: NCT00674609
Status: Completed
Phases: Phase 3
Enrollment: 177 participants, actual
Lead sponsor: Jazz Pharmaceuticals
Conditions: Palliative Care, Pain, Cancer
Interventions: Placebo, Sativex®, THC Alone
First posted: 2008-05-08
Last updated: 2023-05-03
Results first posted: 2012-08-13

Source ClinicalTrials.gov

Registered outcomes9

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

List	Outcome	Time frame	Description
Primary	The Change in Mean Pain Numerical Rating Scale (NRS) Score From Baseline to the End of the Treatment.	2 weeks: baseline - end of week 2 (last 3 days of treatment)	The pain NRS was complete at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours" where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain due to cancer. A negative value indicates an improvement in pain score from baseline.
Primary	The Consumption of Escape Analgesic Medication.	2 weeks: baseline - end of week 2 (last 3 days of treatment)	Subjects recorded their use of escape medication each day on their diary card.
Secondary	Sleep Disturbance 0-10 Numerical Rating Scale	2 weeks: baseline to end of week 2 (last 3 days of treatment)	The sleep disruption NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate how your pain disrupted your sleep last night?" where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline.
Secondary	Nausea 0-10 Numerical Rating Scale	2 weeks; baseline - end of week 2 (last 3 days of treatment)	The nausea NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate how sick you felt throughout the day?" where 0 = not sick at all and 10 = very sick. A negative value indicates an improvement in nausea score from baseline.
Secondary	Memory 0-10 Numerical Rating Scale	2 weeks: baseline - end of week 2 (last 3 days of treatment)	The memory NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate how well you are able to remember what you have done in the past 24 hours?" where 0 = very well and 10 = not at all. A negative value indicates an improvement in memory score from baseline.
Secondary	Appetite 0-10 Numerical Rating Scale	2 weeks: baseline - end of week 2 (last 3 days of treatment)	The appetite NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate how your appetite has been throughout the day?" where 0 = very good and 10 = very poor. A negative value indicates an improvement in appetite score from baseline.
Secondary	Concentration 0-10 Numerical Rating Scale	2 weeks: baseline - end of week 2 (last 3 days of treatment)	The concentration NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate how well have you been able to concentrate throughout the day e.g. when reading a newspaper?" where 0 = very well and 10 = not at all. A negative value indicates an improvement in concentration score from baseline.
Secondary	EORTC Quality of Life Questionnaire (EORTC-QLQC30)	2 weeks; baseline and end of treatment (2 weeks)	Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), a core cancer-specific questionnaire containing 30 items on patients' functioning, global quality of life, disease- and treatment related symptoms. Higher scores indicate a greater degree of symptoms, min.: 0, Max.: 100
Secondary	Brief Pain Inventory Short Form	End of 2 weeks	The BPI-SF is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The severity composite score was calculated as the arithmetic mean of the four severity items(range 0-10). The minimum value is zero and maximum is 10. A higher score represents a poor outcome.

Source ClinicalTrials.gov

Outcomes9

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	The Change in Mean Pain Numerical Rating Scale (NRS) Score From Baseline to the End of the Treatment.	2 weeks: baseline - end of week 2 (last 3 days of treatment)	All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population. This population was used for the primary analysis. Presented below is the adjusted mean change from baseline in mean pain NRS.	units on a scale	MEAN
SECONDARY	Sleep Disturbance 0-10 Numerical Rating Scale	2 weeks: baseline to end of week 2 (last 3 days of treatment)	All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.	units on a scale	MEAN
SECONDARY	Nausea 0-10 Numerical Rating Scale	2 weeks; baseline - end of week 2 (last 3 days of treatment)	All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.	units on a scale	MEAN
SECONDARY	Memory 0-10 Numerical Rating Scale	2 weeks: baseline - end of week 2 (last 3 days of treatment)	All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.	units on a scale	MEAN
SECONDARY	Appetite 0-10 Numerical Rating Scale	2 weeks: baseline - end of week 2 (last 3 days of treatment)	All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.	units on a scale	MEAN
SECONDARY	Concentration 0-10 Numerical Rating Scale	2 weeks: baseline - end of week 2 (last 3 days of treatment)	All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.	units on a scale	MEAN
SECONDARY	EORTC Quality of Life Questionnaire (EORTC-QLQC30)	2 weeks; baseline and end of treatment (2 weeks)	All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.	units on a scale	MEAN
SECONDARY	Brief Pain Inventory Short Form	End of 2 weeks	All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.	units on a scale	MEAN
PRIMARY	The Consumption of Escape Analgesic Medication.	2 weeks: baseline - end of week 2 (last 3 days of treatment)	The primary population for this analysis was the intention-to-treat (ITT) population, which included all randomised subjects who received at least 1 dose of study medication and had on-treatment efficacy data. The primary analysis escape medication usage i.e. the number of days escape medication was used did not include any covariates.	tablets per day	MEAN

Source ClinicalTrials.gov

Results by group27

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

Outcome	Group	Value	Spread	Units
The Change in Mean Pain Numerical Rating Scale (NRS) Score From Baseline to the End of the Treatment.	Sativex	-1.32	Standard Deviation 1.64	units on a scale
The Change in Mean Pain Numerical Rating Scale (NRS) Score From Baseline to the End of the Treatment.	THC Alone	-0.93	Standard Deviation 1.15	units on a scale
The Change in Mean Pain Numerical Rating Scale (NRS) Score From Baseline to the End of the Treatment.	Placebo	-0.73	Standard Deviation 1.51	units on a scale
Sleep Disturbance 0-10 Numerical Rating Scale	Sativex	-0.59	Standard Deviation 1.88	units on a scale
Sleep Disturbance 0-10 Numerical Rating Scale	THC Alone	-0.25	Standard Deviation 2.33	units on a scale
Sleep Disturbance 0-10 Numerical Rating Scale	Placebo	-0.21	Standard Deviation 1.72	units on a scale
Nausea 0-10 Numerical Rating Scale	Sativex	0	Standard Deviation 2.19	units on a scale
Nausea 0-10 Numerical Rating Scale	THC Alone	0.27	Standard Deviation 1.83	units on a scale
Nausea 0-10 Numerical Rating Scale	Placebo	-0.16	Standard Deviation 1.25	units on a scale
Memory 0-10 Numerical Rating Scale	Sativex	0.58	Standard Deviation 2.06	units on a scale

1 to 10 of 27Source ClinicalTrials.gov

See all 27 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Sativex	60
Overall Study	STARTED	THC Alone	58
Overall Study	STARTED	Placebo	59
Overall Study	COMPLETED	Sativex	48
Overall Study	COMPLETED	THC Alone	45
Overall Study	COMPLETED	Placebo	51
Overall Study	NOT COMPLETED	Sativex	12
Overall Study	NOT COMPLETED	THC Alone	13
Overall Study	NOT COMPLETED	Placebo	8

Source ClinicalTrials.gov

Adverse events153

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	Somnolence	Nervous system disorders	Sativex	9	60
other	Somnolence	Nervous system disorders	THC Alone	8	58
other	Somnolence	Nervous system disorders	Placebo	8	59
other	Nausea	Gastrointestinal disorders	Sativex	7	60
other	Nausea	Gastrointestinal disorders	THC Alone	6	58
other	Nausea	Gastrointestinal disorders	Placebo	6	59
other	Dizziness	Nervous system disorders	Sativex	7	60
other	Dizziness	Nervous system disorders	THC Alone	7	58
other	Dizziness	Nervous system disorders	Placebo	3	59
other	Neoplasm progression NOS	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Sativex	6	60

1 to 10 of 153Source ClinicalTrials.gov

See all 153 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Sativex
Total, all-cause mortality	THC Alone
Total, all-cause mortality	Placebo
Total, other adverse events	Sativex	51	60
Total, other adverse events	THC Alone	45	58
Total, other adverse events	Placebo	44	59
Total, serious adverse events	Sativex	13	60
Total, serious adverse events	THC Alone	13	58
Total, serious adverse events	Placebo	7	59

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
19896326	RESULT

Source PubMed

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.

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