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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00603577 |
Primary objective:
To assess the effect of xaliproden hydrochloride (xaliproden) 1 mg per oral daily on the rate of complete resolution of PSN at 6 months, following randomization, after the completion of oxaliplatin-based adjuvant chemotherapy for colon cancer.
Secondary objective:
Condition | Intervention | Phase |
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Colorectal Neoplasms |
Drug: placebo Drug: xaliproden |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Center, Randomized, Double Blind, Placebo Controlled Phase III Study to Assess the Efficacy of Xaliproden in Patients With Oxaliplatin-Induced Peripheral Sensory Neuropathy (PSN) Following Adjuvant Chemotherapy for Colon Cancer |
Estimated Enrollment: | 244 |
Study Start Date: | January 2008 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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2: Placebo Comparator |
Drug: placebo
placebo
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1: Experimental |
Drug: xaliproden
1.0 mg capsule or matching placebo. One capsule of investigational product (IP) daily for 6 months or until resolution of PSN (whichever comes first).
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contact: PUBLIC REGISTRY GMA | PUBLICREGISTRYGMA@sanofi-aventis.com |
United States, New Jersey | |
Sanofi-Aventis | Recruiting |
Bridgewater, New Jersey, United States | |
Canada | |
Sanofi-Aventis | Recruiting |
Laval, Canada | |
France | |
Sanofi-Aventis | Recruiting |
Paris, France | |
Germany | |
Sanofi-Aventis | Recruiting |
Frankfurt, Germany | |
Italy | |
Sanofi-Aventis | Recruiting |
Milan, Italy | |
Spain | |
Sanofi-Aventis | Recruiting |
Barcelona, Spain | |
United Kingdom | |
Sanofi-Aventis | Recruiting |
Guildford, United Kingdom |
Principal Investigator: | Jean-Philippe Aussel | Sanofi-Aventis |
Responsible Party: | sanofi-aventis groupe ( Medical Affairs Study Director ) |
Study ID Numbers: | XALIP_C_02090 |
Study First Received: | January 17, 2008 |
Last Updated: | December 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00603577 |
Health Authority: | United States: Food and Drug Administration |
Oxaliplatin Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases |
Gastrointestinal Neoplasms Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms |
Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |