CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 214 enrolled
Drug / intervention
Mebendazole polymorph A and C 500 mg +2 moredrug
Likely dose
Mebendazole polymorph A and C 500 mgfrom 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/NCT01350271
NCT01350271Phase 3Completed
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Comparative Efficacy of Different Mebendazole Polymorphs in the Treatment of Soil-transmitted Helminth Infections

University of Kelaniya·interventional·Posted May 9, 2011·Updated Apr 22, 2013

In Brief

A Phase 3 clinical trial evaluating Mebendazole polymorph A and C 500 mg, Mebendazole polymorph C, and 1 other intervention for Necator Americanus Infection. Completed, enrolled 214 participants across 2 sites.

Detailed Summary

Mebendazole tablets which are produced by most pharmaceutical manufacturers, including the State Pharmaceutical Manufacturing Corporation (SPMC) of Sri Lanka, contain a mixture of polymorphs A and C. However, there is some evidence to show that mebendazole polymorph C is the only form effective against the soil-transmitted helminths. This protocol describes a stratified, randomized, placebo-controlled trial that examined the efficacy of different mebendazole polymorphs produced by the SPMC in the treatment of hookworm infections.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNecator Americanus Infection
CountriesSri Lanka
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 9, 2011
Enrollment StartMay 1, 2011
Primary CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 15.1 years ago

Interventions

Mebendazole polymorph A and C 500 mgdrug

Mebendazole tablets produced by the State Pharmaceutical Manufacturing Corporation of Sri Lanka, containing 500mg of mebendazole as a 50:50 mixture of Polymorphs A and C

Mebendazole polymorph Cdrug

Mebendazole tablets manufactured by the State Pharmaceutical Manufacturing Corporation of Sri Lanka, containing 500mg dose of mebendazole as Polymorph C alone

Placebodrug

Placebo tablets produced by the State Pharmaceutical Manufacturing Corporation of Sri Lanka