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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 is a Phase 2 study that was terminated before completion, run by Sanofi. The registered enrollment target is 5 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01439919
The ClinicalTrials.gov registry entry for NCT01439919 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which SSR411298 is the first listed.
NCT01439919 reports 0 study locations.
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.
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