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NCT00603577 · ClinicalTrials.gov registry record · Phase 3
Role of Xaliproden on Recovery Rate From Severe Neuropathy in Patients Who Have Completed Adjuvant Chemotherapy With Oxaliplatin Based Regimens
A Phase 3 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 3
- Development phase
- 102
- Enrollment target
NCT00603577 is a Phase 3 study that was terminated before completion, run by Sanofi. The registered enrollment target is 102 participants.
The verdict
NCT00603577, a Phase 3 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 102 participants
- Enrollment target
Study Summary
Primary objective: To assess the effect of xaliproden hydrochloride (xaliproden) 1 mg per oral daily on the rate of complete resolution of peripheral sensory neuropathy (PSN) at 6 months, following randomization, after the completion of oxaliplatin-based adjuvant chemotherapy for colon cancer. Secondary objective: * To assess the effect of xaliproden on patient-reported outcomes using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity scale (FACT/GOG NTX-12 subscale). * To assess the effect of xaliproden on the rate of at least partial recovery of grade \> 2 PSN at 6 months * To assess the effects of xaliproden on the time to complete recovery from PSN * To evaluate the safety profile of xaliproden
Interventions
- DRUG Placebo
- DRUG Xaliproden
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2008-01 |
| Est. Completion | 2009-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00603577
The ClinicalTrials.gov registry entry for NCT00603577 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 102 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 Placebo is the first listed.
NCT00603577 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00603577 about?
NCT00603577 is a clinical study titled "Role of Xaliproden on Recovery Rate From Severe Neuropathy in Patients Who Have Completed Adjuvant Chemotherapy With Oxaliplatin Based Regimens". Primary objective: To assess the effect of xaliproden hydrochloride (xaliproden) 1 mg per oral daily on the rate of complete resolution of peripheral sensory neuropathy (PSN) at 6 months, following randomization, after the completion of oxaliplatin-based adjuvant chemotherapy for colon cancer. Sec...
What is the current status of trial NCT00603577?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 102 participants. The study started on 2008-01. Estimated completion is 2009-11.
What interventions are being tested in trial NCT00603577?
The interventions under investigation include: Placebo (DRUG), Xaliproden (DRUG).
Who is sponsoring clinical trial NCT00603577?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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