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NCT01439919 · ClinicalTrials.gov registry record · Phase 2
A Clinical Trial to Assess the Clinical Benefit of SSR411298 as Adjunctive Treatment for Persistent Cancer Pain
A Phase 2 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT01439919: Clinical Trial Phase 2 study, sponsored by Sanofi.
NCT01439919 is a Phase 2 study that was terminated before completion, run by Sanofi. The registered enrollment target is 5 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01439919, a Phase 2 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the efficacy of SSR411298 200 mg daily compared to placebo as adjunctive treatment for persistent cancer pain based on Numeric Rating Scale (NRS). Secondary Objectives are: * To evaluate the effect of SSR411298 200 mg daily on pain, breakthrough pain frequency, background therapy utilization, mood, patient satisfaction of pain relief, nausea, constipation, healthcare utilization and quality of life; * To evaluate the tolerability and safety of SSR411298 as adjunctive treatment for persistent cancer pain; * To characterize patient disease, in terms of cancer, cancer treatment, cancer pain and cancer pain treatment; * To evaluate the pharmacokinetic (PK) exposure of SSR411298 as adjunctive treatment for persistent cancer pain; * To assess endocannabinoid plasma concentrations.
Primary Outcome
The NRS is an 11-category descriptive anchor scale that is one of the most frequently employed and accepted scales for pain evaluation. Score ranges from 0 \[no pain\] to 10 \[worst possible pain\]. Average NRS score is defined as the average of pain intensity scores measured daily by NRS during a week.
Interventions
- DRUG SSR411298
- DRUG Placebo (for SSR411298)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2012-01 |
| Est. Completion | 2012-02 |
| Phase | Phase 2 |
Why NCT01439919 stopped before completion
NCT01439919 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which SSR411298 is the first listed.
NCT01439919 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01439919 about?
NCT01439919 is a clinical study titled "A Clinical Trial to Assess the Clinical Benefit of SSR411298 as Adjunctive Treatment for Persistent Cancer Pain". The primary objective of this study is to evaluate the efficacy of SSR411298 200 mg daily compared to placebo as adjunctive treatment for persistent cancer pain based on Numeric Rating Scale (NRS). Secondary Objectives are: * To evaluate the effect of SSR411298 200 mg daily on pain, breakthrough p...
What is the current status of trial NCT01439919?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2012-01. Estimated completion is 2012-02.
What interventions are being tested in trial NCT01439919?
The interventions under investigation include: SSR411298 (DRUG), Placebo (for SSR411298) (DRUG).
Who is sponsoring clinical trial NCT01439919?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01439919's enrollment target sits among peer trials
5 2000th of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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