Trial · NCT01424566
A Two-Part Study of Sativex® Oromucosal Spray for Relieving Uncontrolled Persistent Pain in Patients With Advanced Cancer
NCT01424566, Phase 3, Completed, Jazz Pharmaceuticals; results first posted 2018-04-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Two-Part Study of Sativex® Oromucosal Spray for Relieving Uncontrolled Persistent Pain in Patients With Advanced Cancer. Trials, record NCT01424566. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01424566
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Two-Part Study of Sativex® Oromucosal Spray for Relieving Uncontrolled Persistent Pain in Patients With Advanced Cancer
- NCT number
- NCT01424566
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 406 participants, actual
- Lead sponsor
- Jazz Pharmaceuticals
- Conditions
- Pain, Advanced Cancer
- Interventions
- Nabiximols, Placebo (GA-0034)
- First posted
- 2011-08-29
- Last updated
- 2023-04-12
- Other registries' IDs
- eudract:2010-022905-17
- Results first posted
- 2018-04-23
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Randomization Baseline In Mean NRS Average Pain At End Of Treatment | Randomization Baseline, End of Treatment (Day 36 of the double-blind period) | Participants indicated the level of pain experienced in the last 24 hours on an 11-point 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: End of Treatment NRS average pain score - Randomization (Part B) Baseline NRS average pain score. The participant's Randomization (Part B) baseline pain 0-10 NRS value was the mean over the last 4 consecutive days of the single-blind treatment period (Part A; pre-randomization). A negative value indicates an improvement in average pain score from Randomization (Part B) Baseline. |
| Secondary | Percent Improvement From Eligibility Baseline In Mean NRS Average Pain Score At End Of Treatment | Eligibility Baseline, End of Treatment (Day 36 of the double-blind period) | Participants indicated level of pain in the last 24 hours on an 11-point NRS, where a score of 0 was "no pain" and 10 was "pain as bad as you can imagine". Eligibility Baseline = mean score from the 3-day eligibility period. End of Treatment = mean score over last (up to) 4 days to the final pain score at End of Treatment or up until Day 36 of the double-blind period, whichever is earlier, or final score available (prematurely terminated). Percentage improvement from baseline (Imp%) was calculated as: Imp% = (Eligibility Baseline pain NRS mean - End of Treatment pain NRS mean)/Eligibility Baseline pain NRS mean \* 100. For participants who died or withdrew due to disease progression, Imp% values were used. For participants who died or withdrew unrelated to disease progression before end of Week 5, Imp% was zero for participants whose Imp% value was positive and it was Imp% for participants whose Imp% value was not positive. |
| Secondary | Change From Randomization Baseline In Mean NRS Worst Pain At End Of Treatment | Randomization Baseline, End of Treatment (Day 36 of the double-blind period) | Participants indicated the level of worst pain experienced in the last 24 hours on an 11-point 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 worst pain was calculated as: End of Treatment NRS worst pain score - Randomization (Part B) Baseline NRS worst pain score. The participant's Randomization (Part B) baseline worst pain 0-10 NRS value was the mean over the last 4 consecutive days of the single-blind treatment period (Part A; pre-randomization). A negative value indicates an improvement in worst pain score from Randomization (Part B) Baseline. |
| Secondary | Change From Randomization Baseline In Mean Sleep Disruption NRS At End Of Treatment | Randomization Baseline, End of Treatment (Day 36 of the double-blind period) | 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: End of Treatment sleep disruption NRS score - Randomization (Part B) Baseline sleep disruption NRS score. The participant's Randomization (Part B) baseline sleep disruption 0-10 NRS value was the mean over the last 4 consecutive days of the single-blind treatment period (Part A; pre-randomization). A negative value indicates an improvement in sleep disruption score from Randomization (Part B) Baseline. |
| Secondary | Subject Global Impression Of Change At Last Visit (Up To Day 36 Of The Double-blind Period) | Last Visit (up to Day 36 of the double-blind period) | The Subject Global Impression of Change (SGIC) was used to assess the overall status of the participant related to their cancer pain, with the markers "very much improved, much improved, slightly improved, no change, slightly worse, much worse, or very much worse". The SGIC was assessed at Day 36 of the double-blind period or the day at which a participant's last evaluation was performed, such as in the case of early termination. Last visit refers to the last visit that a participant completed the assessment; this could be either Day 22 or Day 36 of the double-blind period. |
| Secondary | Physician Global Impression Of Change At Last Visit (Up To Day 36 Of The Double-blind Period) | Last Visit (up to Day 36 of the double-blind period) | The Physician Global Impression of Change (PGIC) was used by the treating physician (investigator/sub-investigator) to assess if there was any change in the general functional abilities of the participant since prior to commencement of study medication, with the markers: "very much worse, much worse, slightly worse, no change, slightly improved, much improved, very much improved". Last visit refers to the last visit that a participant completed the assessment; this could be either Day 22 or Day 36 of the double-blind period. |
| Secondary | Patient Satisfaction Questionnaire At Last Visit (Up To Day 36 Of The Double-blind Period) | Last Visit (up to Day 36 of the double-blind period) | 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; this could be either Day 22 or Day 36 of the double-blind period. |
| Secondary | Change From Randomization Baseline In Daily Total Opioid Use (Morphine Equivalent) At End Of Treatment | Randomization Baseline, End of Treatment (Day 36 of the double-blind period) | The total daily opioid use (in morphine equivalence) was the sum of morphine equivalence of daily maintenance dose and break-through dose. Change in daily total opioid use was calculated as: End of Treatment daily total opioid use - Randomization (Part B) Baseline daily total opioid use. The participant's Randomization (Part B) baseline daily total opioid use value was the mean over the last 4 consecutive days of the single-blind treatment period (Part A; pre-randomization). A negative value indicates a decrease in use from Randomization (Part B) Baseline. |
| Secondary | Change From Randomization Baseline In Daily Maintenance Opioid Dose (Morphine Equivalent) At End Of Treatment | Randomization Baseline, End of Treatment (Day 36 of the double-blind period) | The prescribed daily quantity of opioid maintenance dose was calculated as the product of dose per use and daily frequency of use. Participants were asked: "Have you used your maintenance dose painkiller today as prescribed?" If the participant answered "No" to the question, the daily opioid maintenance dose usage on that day was set to 0. Change in daily maintenance opioid dose was calculated as: End of Treatment daily maintenance opioid dose - Randomization (Part B) Baseline daily maintenance opioid dose. The participant's Randomization (Part B) baseline daily maintenance opioid dose value was the mean over the last 4 consecutive days of the single-blind treatment period (Part A; pre-randomization). A negative value indicates a decrease in dose from Randomization (Part B) Baseline. |
| Secondary | Change From Randomization Baseline In Daily Break-through Opioid Dose (Morphine Equivalent) At End Of Treatment | Randomization Baseline, End of Treatment (Day 36 of the double-blind period) | Daily break-through opioid dose usage was calculated as the product of prescribed dose per use, and the number of uses per day. If participants took more than 1 different break-through opioid for more than 1 day, the sum of morphine equivalence dose usages for each break-through opioid was calculated for the summary. Change in daily break-through opioid dose was calculated as: End of Treatment daily break-through opioid dose - Randomization (Part B) Baseline daily maintenance opioid dose. The participant's Randomization (Part B) baseline daily break-through opioid dose value was the mean over the last 4 consecutive days of the single-blind treatment period (Part A; pre-randomization). A negative value indicates a decrease in dose from Randomization (Part B) Baseline. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Randomization Baseline In Mean NRS Average Pain At End Of Treatment | Randomization Baseline, End of Treatment (Day 36 of the double-blind period) | The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to. | units on a scale | MEAN |
| SECONDARY | Percent Improvement From Eligibility Baseline In Mean NRS Average Pain Score At End Of Treatment | Eligibility Baseline, End of Treatment (Day 36 of the double-blind period) | The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to. | percent improvement | MEDIAN |
| SECONDARY | Change From Randomization Baseline In Mean NRS Worst Pain At End Of Treatment | Randomization Baseline, End of Treatment (Day 36 of the double-blind period) | The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to. | units on a scale | MEAN |
| SECONDARY | Change From Randomization Baseline In Mean Sleep Disruption NRS At End Of Treatment | Randomization Baseline, End of Treatment (Day 36 of the double-blind period) | The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to. | units on a scale | MEAN |
| SECONDARY | Subject Global Impression Of Change At Last Visit (Up To Day 36 Of The Double-blind Period) | Last Visit (up to Day 36 of the double-blind period) | The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Physician Global Impression Of Change At Last Visit (Up To Day 36 Of The Double-blind Period) | Last Visit (up to Day 36 of the double-blind period) | The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Patient Satisfaction Questionnaire At Last Visit (Up To Day 36 Of The Double-blind Period) | Last Visit (up to Day 36 of the double-blind period) | The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Randomization Baseline In Daily Total Opioid Use (Morphine Equivalent) At End Of Treatment | Randomization Baseline, End of Treatment (Day 36 of the double-blind period) | The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to. | mg (morphine equivalent) | MEAN |
| SECONDARY | Change From Randomization Baseline In Daily Maintenance Opioid Dose (Morphine Equivalent) At End Of Treatment | Randomization Baseline, End of Treatment (Day 36 of the double-blind period) | The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to. | mg (morphine equivalent) | MEAN |
| SECONDARY | Change From Randomization Baseline In Daily Break-through Opioid Dose (Morphine Equivalent) At End Of Treatment | Randomization Baseline, End of Treatment (Day 36 of the double-blind period) | The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to. | mg (morphine equivalent) | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group58
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Randomization Baseline In Mean NRS Average Pain At End Of Treatment | Double-blind Nabiximols | 0.5 | Standard Deviation 1.3 | units on a scale | |
| Change From Randomization Baseline In Mean NRS Average Pain At End Of Treatment | Double-blind Placebo (GA-0034) | 0.5 | Standard Deviation 1.6 | units on a scale | |
| Percent Improvement From Eligibility Baseline In Mean NRS Average Pain Score At End Of Treatment | Double-blind Nabiximols | 33.3 | Inter-Quartile Range 18.2 to 51.8 | percent improvement | |
| Percent Improvement From Eligibility Baseline In Mean NRS Average Pain Score At End Of Treatment | Double-blind Placebo (GA-0034) | 35.7 | Inter-Quartile Range 18.8 to 51.3 | percent improvement | |
| Change From Randomization Baseline In Mean NRS Worst Pain At End Of Treatment | Double-blind Nabiximols | 0.2 | Standard Deviation 1.4 | units on a scale | |
| Change From Randomization Baseline In Mean NRS Worst Pain At End Of Treatment | Double-blind Placebo (GA-0034) | 0.5 | Standard Deviation 1.6 | units on a scale | |
| Change From Randomization Baseline In Mean Sleep Disruption NRS At End Of Treatment | Double-blind Nabiximols | 0.2 | Standard Deviation 1.3 | units on a scale | |
| Change From Randomization Baseline In Mean Sleep Disruption NRS At End Of Treatment | Double-blind Placebo (GA-0034) | 0.5 | Standard Deviation 1.4 | units on a scale | |
| Subject Global Impression Of Change At Last Visit (Up To Day 36 Of The Double-blind Period) | Double-blind Nabiximols | Very Much Improved | 6 | Participants | |
| Subject Global Impression Of Change At Last Visit (Up To Day 36 Of The Double-blind Period) | Double-blind Placebo (GA-0034) | Very Much Improved | 6 | Participants |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Single-blind Treatment | STARTED | Single-blind Nabiximols | 406 | |
| Single-blind Treatment | STARTED | Double-blind Nabiximols | 0 | |
| Single-blind Treatment | STARTED | Double-blind Placebo (GA-0034) | 0 | |
| Single-blind Treatment | Received at Least 1 Dose of Study Drug | Single-blind Nabiximols | 404 | |
| Single-blind Treatment | Received at Least 1 Dose of Study Drug | Double-blind Nabiximols | 0 | |
| Single-blind Treatment | Received at Least 1 Dose of Study Drug | Double-blind Placebo (GA-0034) | 0 | |
| Single-blind Treatment | Single-blind Safety Population | Single-blind Nabiximols | 404 | |
| Single-blind Treatment | Single-blind Safety Population | Double-blind Nabiximols | 0 | |
| Single-blind Treatment | Single-blind Safety Population | Double-blind Placebo (GA-0034) | 0 | |
| Single-blind Treatment | Met Randomization Criteria | Single-blind Nabiximols | 206 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events177
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 | Events |
|---|---|---|---|---|---|---|
| other | Decreased Appetite | Metabolism and nutrition disorders | Single-blind Nabiximols | 0 | 404 | |
| other | Decreased Appetite | Metabolism and nutrition disorders | Double-blind Nabiximols | 6 | 103 | |
| other | Decreased Appetite | Metabolism and nutrition disorders | Double-blind Placebo (GA-0034) | 3 | 103 | |
| other | Nausea | Gastrointestinal disorders | Single-blind Nabiximols | 25 | 404 | |
| other | Nausea | Gastrointestinal disorders | Double-blind Nabiximols | 0 | 103 | |
| other | Nausea | Gastrointestinal disorders | Double-blind Placebo (GA-0034) | 0 | 103 | |
| other | Vomiting | Gastrointestinal disorders | Single-blind Nabiximols | 21 | 404 | |
| other | Vomiting | Gastrointestinal disorders | Double-blind Nabiximols | 0 | 103 | |
| other | Vomiting | Gastrointestinal disorders | Double-blind Placebo (GA-0034) | 0 | 103 | |
| other | Dizziness | Nervous system disorders | Single-blind Nabiximols | 27 | 404 |
1 to 10 of 177Source ClinicalTrials.gov
See all 177 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Single-blind Nabiximols | ||
| Total, all-cause mortality | Double-blind Nabiximols | ||
| Total, all-cause mortality | Double-blind Placebo (GA-0034) | ||
| Total, other adverse events | Single-blind Nabiximols | 97 | 404 |
| Total, other adverse events | Double-blind Nabiximols | 21 | 103 |
| Total, other adverse events | Double-blind Placebo (GA-0034) | 17 | 103 |
| Total, serious adverse events | Single-blind Nabiximols | 80 | 404 |
| Total, serious adverse events | Double-blind Nabiximols | 33 | 103 |
| Total, serious adverse events | Double-blind Placebo (GA-0034) | 16 | 103 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28785408 | BACKGROUND |
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.
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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