NCT01350271

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
214

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 9, 2011

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

April 22, 2013

Completed
Last Updated

April 22, 2013

Status Verified

April 1, 2013

Enrollment Period

1 month

First QC Date

May 6, 2011

Results QC Date

August 23, 2011

Last Update Submit

April 18, 2013

Conditions

Necator Americanus Infection

Keywords

HookwormNecator americanusMebendazole

Outcome Measures

Primary Outcomes (1)

  • Cure Rate

    Cure rate={(Number positive pretreatment - Number positive posttreatment)÷(Number positive pretreatment)}×100

    Two weeks

Secondary Outcomes (2)

  • Faecal Egg Count Reduction 1 (FECR1)

    Two weeks

  • Faecal Egg Count Reduction 2 (FECR2)

    Two weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Mebendazole polymorph A and C 500 mg

ACTIVE COMPARATOR

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

Drug: Mebendazole polymorph A and C 500 mg

Mebendazole polymorph C 500 mg

EXPERIMENTAL

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

Drug: Mebendazole polymorph C

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

Also known as: Lot FG10M01
Mebendazole polymorph A and C 500 mg
Mebendazole polymorph CDRUG

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

Also known as: Lot FG10H01
Mebendazole polymorph C 500 mg
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Necator americanus infection, as determined by examination of a single faecal smear, alone or with Ascaris lumbricoides or Trichuris trichiura

You may not qualify if:

  • Children below the age of 2 years
  • Pregnant women
  • Individuals with diarrhea on day of treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Agalawatta Plantations PLC

Nivithigala, Sabragamuwa, Sri Lanka

Location

Lellopitiya Estate, Hapugastenne Plantations PLC

Ratnapura, Sabragamuwa, Sri Lanka

Location

MeSH Terms

Conditions

Ancylostomiasis

Condition Hierarchy (Ancestors)

Hookworm InfectionsStrongylida InfectionsSecernentea InfectionsNematode InfectionsHelminthiasisParasitic DiseasesInfections

Limitations and Caveats

Small sample size owing to limitation in available funds.

Results Point of Contact

Title
Dr Balachandran Kumarendran
Organization
University of Kelaniya
drbkumaran@gmail.com
0094112961140

Study Officials

  • Nilanthi R de Silva, MD

    Faculty of Medicine, University of Kelaniya, Sri Lanka

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Parasitology

Study Record Dates

First Submitted

May 6, 2011

First Posted

May 9, 2011

Study Start

May 1, 2011

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

April 22, 2013

Results First Posted

April 22, 2013

Record last verified: 2013-04

Locations

SR(2)