Necator Americanus InfectionPhase 3NCT01350271
Comparative Efficacy of Different Mebendazole Polymorphs in the Treatment of Soil-transmitted Helminth Infections
A Phase 3 study testing Mebendazole polymorph A and C 500 mg and Mebendazole polymorph C in people with Necator Americanus Infection, run by University of Kelaniya at 2 sites in Sri Lanka.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Necator Americanus Infection
- What is being tested?
- Mebendazole polymorph A and C 500 mg and Mebendazole polymorph C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 214 participants
- Where
- 2 sitesSri Lanka
- Study dates
- May 2011to Jun 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Necator americanus infection, as determined by examination of a single faecal smear, alone or with Ascaris lumbricoides or Trichuris trichiura
Who cannot join
- Children below the age of 2 years
- Pregnant women
- Individuals with diarrhea on day of treatment
Trial locations and contacts
2 sites in 1 country.
Sri Lanka2 sites
Agalawatta Plantations PLC
Nivithigala, Sabragamuwa
Lellopitiya Estate, Hapugastenne Plantations PLC
Ratnapura, Sabragamuwa
About this study
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.
Read the 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.
- Conditions
- Necator Americanus Infection
- Being tested
- Mebendazole polymorph A and C 500 mg, Mebendazole polymorph C, Placebo
- Keywords
- Hookworm, Necator americanus, Mebendazole
- Medical subject headings
- Ancylostomiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mebendazole polymorph A and C 500 mgDrug
Also called Lot FG10M01
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
Also called Lot FG10H01
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
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo tablets produced by the State Pharmaceutical Manufacturing Corporation of Sri Lanka Receives: 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 Receives: 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 Receives: Drug: Mebendazole polymorph C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure Rate
Cure rate={(Number positive pretreatment - Number positive posttreatment)÷(Number positive pretreatment)}×100
Measured: Two weeks
Secondary outcomes (2)
Faecal Egg Count Reduction 1 (FECR1)
FECR1= {[(Arithmetic mean of pretreatment egg counts)-(arithmetic mean of posttreatment egg counts)]÷(arithmetic mean of pretreatment egg counts)}×100
Measured: Two weeks
Faecal Egg Count Reduction 2 (FECR2)
FECR2=〈Arithmetic mean {[(pretreatment egg count)-(posttreatment egg count)]÷(pretreatment egg count)}〉×100
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2011 (estimated)
- Study startMay 2011
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Necator Americanus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kelaniya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, N R de Silva, University of Kelaniya
- Investigators
- Nilanthi R de Silva, MD, Principal investigator, Faculty of Medicine, University of Kelaniya, Sri Lanka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01350271
- Sponsor's protocol ID
- P39/04/2010
- Other IDs
- Ragama ERC
- Status last verified
- Apr 2013
- First submitted
- 6 May 2011
- Last updated
- 22 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Different Mebendazole Polymorphs in the Treatment of Soil-transmitted Helminth Infections
- ClinicalTrials.gov ID
- NCT01350271
- Acronym / sponsor ID
- P39/04/2010
- Conditions
- Necator Americanus Infection
- Keywords
- Hookworm, Necator americanus, Mebendazole
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- University of KelaniyaUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 9 May 2011 (estimated)
- Results
- Posted 22 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablets produced by the State Pharmaceutical Manufacturing Corporation of Sri Lanka |
| Mebendazole polymorph A and C 500 mg | Active comparator | Drug: Mebendazole polymorph A and C 500 mgMebendazole 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 C 500 mg | Experimental | Drug: Mebendazole polymorph CMebendazole tablets manufactured by the State Pharmaceutical Manufacturing Corporation of Sri Lanka, containing 500mg dose of mebendazole as Polymorph C alone |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Necator americanus infection, as determined by examination of a single faecal smear, alone or with Ascaris lumbricoides or Trichuris trichiura
Key exclusion criteria (3 listed)
- Children below the age of 2 years
- Pregnant women
- Individuals with diarrhea on day of treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mebendazole polymorph A and C 500 mgAlso: Lot FG10M01Mebendazole 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 CAlso: Lot FG10H01Mebendazole tablets manufactured by the State Pharmaceutical Manufacturing Corporation of Sri Lanka, containing 500mg dose of mebendazole as Polymorph C alone | Drug | Mebendazole polymorph C 500 mg |
| PlaceboPlacebo tablets produced by the State Pharmaceutical Manufacturing Corporation of Sri Lanka | Drug | Placebo |
Primary outcome
Cure Rate
Time frame: Two weeks
Cure rate={(Number positive pretreatment - Number positive posttreatment)÷(Number positive pretreatment)}×100
2 secondary outcomes
Faecal Egg Count Reduction 1 (FECR1)
Time frame: Two weeks
Faecal Egg Count Reduction 2 (FECR2)
Time frame: Two weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Necator Americanus Infection
RecruitingPhase 1
Experimental Infection of Hookworm-naïve Adults With Dermally-applied Infectious Necator Americanus Hookworm Larvae
Hookworm Infection
Active, not recruiting
Cement flooRs AnD chiLd hEalth (CRADLE)
Ascaris Lumbricoides Infection, Necator Americanus Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nilanthi R de Silva, MD principal investigator
Faculty of Medicine, University of Kelaniya, Sri Lanka
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mebendazole polymorph A and C 500 mg and Mebendazole polymorph C in people with Necator Americanus Infection, run by University of Kelaniya at 2 sites in Sri Lanka.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sri Lanka. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure Rate (time frame: Two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2013.