At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 389 enrolled

Drug / intervention

Pyridoxine +1 moredrug

Likely dose

Pyridoxine 100mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00446147

NCT00446147Phase 3Completed

Compare CT.gov

Double-Blind Phase III Study of Pyridoxine vs Placebo for the Prevention of Capecitabine-induced Hand-Foot Syndrome

Asan Medical Center·interventional·Posted Mar 12, 2007·Updated Feb 25, 2014

In Brief

A Phase 3 clinical trial evaluating Pyridoxine and Placebo for Hand-foot Syndrome. Completed, enrolled 389 participants.

Detailed Summary

Although pyridoxine has been used empirically for the prevention of capecitabine associated hand-foot syndrome (HFS), its efficacy needs to be demonstrated in prospective controlled trials. The investigators therefore performed a prospective randomized double-blind study to determine whether pyridoxine 200 mg/day can prevent the development of HFS when given concurrently with capecitabine. The investigators also tested the ability of pyridoxine to treat primary occurrence of grade 2-3 HFS.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHand-foot Syndrome

Countries--

Collaborators--

Timeline

Phase 3CompletedFinished

200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJun 2004

Primary CompletionDec 2006

First PostedMar 2007

TodayJul 2026

First PostedMar 12, 2007

Enrollment StartJun 1, 2004

Primary CompletionDec 1, 2006

TodayJul 2, 2026

Enrollment to primary: 2.5 yearsPosted 19.3 years ago

Interventions

Pyridoxinedrug

100mg BID/daily, Per oral

Placebodrug

placebo 100mg BID/daily, Per oral