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NCT01361607 · ClinicalTrials.gov registry record · Phase 3
Sativex® for Relieving Persistent Pain in Patients With Advanced Cancer
A Phase 3 study of Pain and Advanced Cancer, sponsored by Jazz Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 399
- Enrollment target
- 20
- Study locations
NCT01361607: Completed Phase 3 study of Pain and Advanced Cancer, sponsored by Jazz Pharmaceuticals.
NCT01361607 is a Phase 3 study of Pain and Advanced Cancer that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 399 participants, above the 303-participant average among 374 other Pain trials with a reported enrollment target (32% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01361607, a Phase 3 study of Pain and Advanced Cancer, has completed, sponsored by Jazz Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 399 participants
- Enrollment target
- 20
- Study locations
Study Summary
This 9-week study aimed to determine the efficacy, safety, and tolerability of nabiximols (Sativex®) as an adjunctive treatment, compared with placebo in relieving uncontrolled persistent chronic pain in participants with advanced cancer. Eligible participants were not required to stop any of their current treatments or medications.
Primary Outcome
Participants indicated level of pain in the last 24 hours on an 11-point Numerical Rating Scale (NRS), where a score of 0 was "no pain" and 10 was "pain as bad as you can imagine". Baseline = mean score from first day of 3-day eligibility period through to the day before first dose of study drug. End of Treatment = mean score over last (up to) 7 days to the final pain score at End of Treatment or up until Day 35, whichever is earlier, or final score available (prematurely terminated). Percentag
Conditions Studied
Interventions
- DRUG Nabiximols
- DRUG Placebo (GA-0034)
Study Locations (20)
Florida
- - Clearwater
- - Holiday
- - Miami
- - Stuart
Georgia
- - Marietta
- - Newnan
- - Stockbridge
California
- - Glendale
- - Santa Rosa
Illinois
- - Gurnee
- - Mount Vernon
Louisiana
- - Bossier City
- - Shreveport
New York
- - New York
- - New York
Kentucky
- - Ashland
Montana
- - Missoula
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 399 participants |
| Start Date | 2011-05-27 |
| Est. Completion | 2014-11-24 |
| Phase | Phase 3 |
What the finished NCT01361607 record still lists
NCT01361607 is an interventional study that assigns participants to a tested intervention. The registered 399 participants enrollment target is mid-sized for trials with a published cap, above the 303-participant average among 374 other Pain trials with a reported enrollment target (32% higher).
The record links to 2 conditions, with Pain appearing as the primary indexed condition, and to 2 interventions - of which Nabiximols is the first listed.
NCT01361607 names 20 study sites across 11 states, led by Florida, Georgia, California.
Frequently Asked Questions
What is clinical trial NCT01361607 about?
NCT01361607 is a clinical study titled "Sativex® for Relieving Persistent Pain in Patients With Advanced Cancer". This 9-week study aimed to determine the efficacy, safety, and tolerability of nabiximols (Sativex®) as an adjunctive treatment, compared with placebo in relieving uncontrolled persistent chronic pain in participants with advanced cancer. Eligible participants were not required to stop any of their...
What is the current status of trial NCT01361607?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 399 participants. The study started on 2011-05-27. Estimated completion is 2014-11-24.
What conditions does trial NCT01361607 study?
This clinical trial studies the following conditions: Pain, Advanced Cancer.
What interventions are being tested in trial NCT01361607?
The interventions under investigation include: Nabiximols (DRUG), Placebo (GA-0034) (DRUG).
Who is sponsoring clinical trial NCT01361607?
This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01361607 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Illinois, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT01361607's enrollment target sits among peer trials
399 48th of 374 higher than 327 of 374 other Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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