Trial · NCT01350271
Comparative Efficacy of Different Mebendazole Polymorphs in the Treatment of Soil-transmitted Helminth Infections
NCT01350271, Phase 3, Completed, University of Kelaniya; results first posted 2013-04-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparative Efficacy of Different Mebendazole Polymorphs in the Treatment of Soil-transmitted Helminth Infections. Trials, record NCT01350271. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01350271
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparative Efficacy of Different Mebendazole Polymorphs in the Treatment of Soil-transmitted Helminth Infections
- NCT number
- NCT01350271
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 214 participants, actual
- Lead sponsor
- University of Kelaniya
- Conditions
- Necator Americanus Infection
- Interventions
- Mebendazole polymorph A and C 500 mg, Mebendazole polymorph C, Placebo
- First posted
- 2011-05-09
- Last updated
- 2013-04-22
- Results first posted
- 2013-04-22
- Limitations and caveats
- Small sample size owing to limitation in available funds.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cure Rate | Two weeks | Cure rate={(Number positive pretreatment - Number positive posttreatment)÷(Number positive pretreatment)}×100 |
| Secondary | Faecal Egg Count Reduction 1 (FECR1) | Two weeks | FECR1= {\[(Arithmetic mean of pretreatment egg counts)-(arithmetic mean of posttreatment egg counts)\]÷(arithmetic mean of pretreatment egg counts)}×100 |
| Secondary | Faecal Egg Count Reduction 2 (FECR2) | Two weeks | FECR2=〈Arithmetic mean {\[(pretreatment egg count)-(posttreatment egg count)\]÷(pretreatment egg count)}〉×100 |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cure Rate | Two weeks | All participants who were hookworm positive at baseline, and who provided a faecal sample for examination at follow up. | percentage of participants | NUMBER |
| SECONDARY | Faecal Egg Count Reduction 1 (FECR1) | Two weeks | All participants who were hookworm positive at baseline, and who provided a faecal sample for examination at follow-up, were included in the analysis | percentage of eggs excreted | NUMBER |
| SECONDARY | Faecal Egg Count Reduction 2 (FECR2) | Two weeks | All participants who were hookworm positive at baseline, and who provided a faecal sample for examination at follow up were included in the analysis | percentage of eggs excreted | MEAN |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cure Rate | Placebo | 16.3 | percentage of participants | ||
| Cure Rate | Mebendazole Polymorph A and C 500 mg | 28.3 | percentage of participants | ||
| Cure Rate | Mebendazole Polymorph C 500 mg | 18.8 | percentage of participants | ||
| Faecal Egg Count Reduction 1 (FECR1) | Placebo | -6.6 | percentage of eggs excreted | ||
| Faecal Egg Count Reduction 1 (FECR1) | Mebendazole Polymorph A and C 500 mg | 86.1 | percentage of eggs excreted | ||
| Faecal Egg Count Reduction 1 (FECR1) | Mebendazole Polymorph C 500 mg | 84.5 | percentage of eggs excreted | ||
| Faecal Egg Count Reduction 2 (FECR2) | Placebo | -108.1 | Standard Deviation 557.5 | percentage of eggs excreted | |
| Faecal Egg Count Reduction 2 (FECR2) | Mebendazole Polymorph A and C 500 mg | 66.2 | Standard Deviation 42.5 | percentage of eggs excreted | |
| Faecal Egg Count Reduction 2 (FECR2) | Mebendazole Polymorph C 500 mg | 49.8 | Standard Deviation 82.6 | percentage of eggs excreted |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 70 | |
| Overall Study | STARTED | Mebendazole Polymorph A and C 500 mg | 70 | |
| Overall Study | STARTED | Mebendazole Polymorph C 500 mg | 74 | |
| Overall Study | COMPLETED | Placebo | 49 | |
| Overall Study | COMPLETED | Mebendazole Polymorph A and C 500 mg | 53 | |
| Overall Study | COMPLETED | Mebendazole Polymorph C 500 mg | 48 | |
| Overall Study | NOT COMPLETED | Placebo | 21 | |
| Overall Study | NOT COMPLETED | Mebendazole Polymorph A and C 500 mg | 17 | |
| Overall Study | NOT COMPLETED | Mebendazole Polymorph C 500 mg | 26 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Mebendazole Polymorph A and C 500 mg | ||
| Total, all-cause mortality | Mebendazole Polymorph C 500 mg | ||
| Total, other adverse events | Placebo | 0 | 70 |
| Total, other adverse events | Mebendazole Polymorph A and C 500 mg | 0 | 70 |
| Total, other adverse events | Mebendazole Polymorph C 500 mg | 0 | 74 |
| Total, serious adverse events | Placebo | 0 | 70 |
| Total, serious adverse events | Mebendazole Polymorph A and C 500 mg | 0 | 70 |
| Total, serious adverse events | Mebendazole Polymorph C 500 mg | 0 | 74 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01350271
GET https://conductscience.org/api/trials/v1/NCT01350271/registered