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NCT01337089 · ClinicalTrials.gov registry record · Phase 3
Long Term Safety of Sativex Oromucosal Spray (Sativex®; Nabiximols) as Adjunctive Therapy in Patients With Uncontrolled Persistent Chronic Cancer Related Pain
A Phase 3 study, sponsored by Jazz Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 660
- Enrollment target
NCT01337089: Completed Phase 3 study, sponsored by Jazz Pharmaceuticals.
NCT01337089 is a Phase 3 study that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 660 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (15% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01337089, a Phase 3 study, has completed, sponsored by Jazz Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 660 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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.
Interventions
- DRUG Nabiximols
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 660 participants |
| Start Date | 2011-01-19 |
| Est. Completion | 2016-01-27 |
| Phase | Phase 3 |
What the finished NCT01337089 record still lists
NCT01337089 is an interventional study that assigns participants to a tested intervention. The registered 660 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (15% lower).
The record links to 0 conditions, and to 1 intervention - of which Nabiximols is the first listed.
NCT01337089 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01337089 about?
NCT01337089 is a clinical study titled "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...
What is the current status of trial NCT01337089?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 660 participants. The study started on 2011-01-19. Estimated completion is 2016-01-27.
What interventions are being tested in trial NCT01337089?
The interventions under investigation include: Nabiximols (DRUG).
Who is sponsoring clinical trial NCT01337089?
This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01337089's enrollment target sits among peer trials
660 556th of 2000 higher than 1,440 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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