Ignite Creation Date:
2024-05-05 @ 11:33 PM
Last Modification Date:
2024-10-26 @ 10:35 AM
Study NCT ID:
NCT01350271
Status:
COMPLETED
Last Update Posted:
2013-04-22
First Post:
2011-05-06
Brief Title:
Comparative Efficacy of Different Mebendazole Polymorphs in the Treatment of Soil-transmitted Helminth Infections
Sponsor:
University of Kelaniya
Organization:
University of Kelaniya
Study Overview
Official Title:
Comparative Efficacy of Different Mebendazole Polymorphs in the Treatment of Soil-transmitted Helminth Infections
Status:
COMPLETED
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Mebendazole has three polymorphic forms identified as A B and C All of them are in accord with the US Pharmacopeia specifications USP XXI but they have distinct physiochemical characteristics Himmelreich et al 1977 and different therapeutic activities in experimentally infected mice with Trichinella spiralis infections Rodriguez-Caabeiro et al 1987 The original mebendazole tablets which were used to treat human infections had more than 90 of polymorph C Van den Bossche et al 1982 but most pharmacopeias currently do not specify the proportion of polymorph C that a tablet of mebendazole should contain and the assay specified for measurement of the active ingredient measures all polymorphs together There is some evidence to show that unlike polymorph C polymorph A is ineffective in the treatment of hookworm and whipworm infections Charoenlarp et al 1993 The State Pharmaceutical Manufacturing Corporation of Sri Lanka produces both 500 mg and 100 mg tablets of mebendazole according to specifications laid down in the US Pharmacopeia These tablets contain a mixture of polymorphs A and C It is possible that increasing the content of mebendazole polymorph C in single dose tablets may improve cure rates and egg reduction rates especially against hookworm and whipworm infections where much variation in efficacy has been observed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Ragama ERC | REGISTRY | wwwclinicaltrialsorg | None |