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NCT00305188 · ClinicalTrials.gov registry record · Phase 3
Evaluation of the Efficacy of Xaliproden (SR57746A) in Preventing the Neurotoxicity of Oxaliplatin / 5FU/LV Chemotherapy.
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 879
- Enrollment target
NCT00305188: Completed Phase 3 study, sponsored by Sanofi.
NCT00305188 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 879 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (14% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00305188, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 879 participants
- Enrollment target
Study Summary
Primary Objective : Compare the risk of occurrence of Grade3-4 cumulative peripheral sensory neuropathy (PSN) relative to cumulative dose of oxaliplatin between treatment group and placebo group. Main Secondary Objective : Compare the response rate (RR) between treatment group and placebo group in order to ensure that the efficacy of the chemotherapy is not compromised by the addition of xaliproden to the chemotherapeutic regimen. Other Secondary Objectives : study of the neurotoxicity parameters (Duration of oxaliplatin-induced PSN (G2,3,4); overall incidence of PSN during treatment; dose of onset of PSN ; incidence of dose-reduction and dose delay due to PSN; incidence of oxaliplatin treatment discontinuation due to PSN; change in Nerve Conduction Studies (NCS)) ; study of the safety profile (other than PSN) ; study of the chemotherapy efficacy (progression free survival, overall survival).
Interventions
- DRUG Placebo
- DRUG Leucovorin
- DRUG Oxaliplatin
- DRUG 5-Fluorouracil
- DRUG Xaliproden (SR57746A)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 879 participants |
| Start Date | 2005-12 |
| Est. Completion | 2009-10 |
| Phase | Phase 3 |
What the finished NCT00305188 record still lists
NCT00305188 is an interventional study that assigns participants to a tested intervention. The registered 879 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (14% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT00305188 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00305188 about?
NCT00305188 is a clinical study titled "Evaluation of the Efficacy of Xaliproden (SR57746A) in Preventing the Neurotoxicity of Oxaliplatin / 5FU/LV Chemotherapy.". Primary Objective : Compare the risk of occurrence of Grade3-4 cumulative peripheral sensory neuropathy (PSN) relative to cumulative dose of oxaliplatin between treatment group and placebo group. Main Secondary Objective : Compare the response rate (RR) between treatment group and placebo group in ...
What is the current status of trial NCT00305188?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 879 participants. The study started on 2005-12. Estimated completion is 2009-10.
What interventions are being tested in trial NCT00305188?
The interventions under investigation include: Placebo (DRUG), Leucovorin (DRUG), Oxaliplatin (DRUG), 5-Fluorouracil (DRUG), Xaliproden (SR57746A) (DRUG).
Who is sponsoring clinical trial NCT00305188?
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 NCT00305188's enrollment target sits among peer trials
879 370th of 2000 higher than 1,631 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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