Parasitic DiseasesNCT01050452
Safety and Efficacy of Drug Combinations Against Trichuris Trichiura
A study testing albendazole, mebendazole and ivermectin in people with Parasitic Diseases, run by DBL -Institute for Health Research and Development at 1 site in Uganda.
Trial summary
This randomised, controlled, double-blinded clinical study investigates the safety and efficacy of albendazole (ALB), mebendazole (MBD) and ivermectin (IVM) separately, and ALB and MBD each in combination with IVM in the treatment of Trichuris trichiura in children aged 5-14 years. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Parasitic Diseases
- What is being tested?
- albendazole, mebendazole and ivermectin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 750 participants
- Where
- 1 siteUganda
- Study dates
- Oct 2007to Aug 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Those who are enrolled in class one to six
- Are infected with T. trichiura
- Whose parent consent and who are willing to participate
Who cannot join
- Those with acute and chronic diseases other than T. trichiura
- Those with a history of any serious adverse drug reactions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gaps in Helminth Control: Safety and Efficacy of Drug Combinations. Study on Trichuris Trichiura.
This randomised, controlled, double-blinded clinical study investigates the safety and efficacy of albendazole (ALB), mebendazole (MBD) and ivermectin (IVM) separately, and ALB and MBD each in combination with IVM in the treatment of Trichuris trichiura in children aged 5-14 years.
- Conditions
- Parasitic Diseases
- Being tested
- albendazole, mebendazole, ivermectin, albendazole + ivermectin, mebendazole + ivermectin
- Medical subject headings
- Parasitic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
albendazoleDrug
albendazole (400 mg on dose)
mebendazoleDrug
mebendazole (500 mg one dose)
ivermectinDrug
ivermectin (200 microgram/kg body weight)
albendazole + ivermectinDrug
albendazole (400 mg one dose) + ivermectin (200 mg microgram/kg body weight)
mebendazole + ivermectinDrug
mebendazole (500 mg one dose) + ivermectin (200 microgram/kg body weight)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | albendazole treatment Receives: Drug: albendazole |
| 2 | Active comparator | mebendazole treatment Receives: Drug: mebendazole |
| 3 | Active comparator | ivermectin treatment Receives: Drug: ivermectin |
| 4 | Active comparator | albendazole + ivermectin treatment Receives: Drug: albendazole + ivermectin |
| 5 | Active comparator | mebendazole + ivermectin treatment Receives: Drug: mebendazole + ivermectin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Record adverse reactions
Measured: 6 weeks
Secondary outcomes (1)
Efficacy of treatment
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2010 (estimated)
- Study startOct 2007
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parasitic DiseasesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DBL -Institute for Health Research and Development
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01050452
- Sponsor's protocol ID
- AO.UGA.TRI
- Other IDs
- DBL-CHRD
- Status last verified
- Jan 2010
- First submitted
- 22 Jan 2008
- Last updated
- 15 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Namwanje H, Kabatereine NB, Olsen A. Efficacy of single and double doses of albendazole and mebendazole alone and in combination in the treatment of Trichuris trichiura in school-age children in Uganda. Trans R Soc Trop Med Hyg. 2011 Oct;105(10):586-90. doi: 10.1016/j.trstmh.2011.07.009. Epub 2011 Aug 31.
PubMed 21885077
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gaps in Helminth Control: Safety and Efficacy of Drug Combinations. Study on Trichuris Trichiura.
- ClinicalTrials.gov ID
- NCT01050452
- Acronym / sponsor ID
- AO.UGA.TRI
- Conditions
- Parasitic Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- DBL -Institute for Health Research and DevelopmentUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 15 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomised, controlled, double-blinded clinical study investigates the safety and efficacy of albendazole (ALB), mebendazole (MBD) and ivermectin (IVM) separately, and ALB and MBD each in combination with IVM in the treatment of Trichuris trichiura in children aged 5-14 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: albendazolealbendazole treatment |
| 2 | Active comparator | Drug: mebendazolemebendazole treatment |
| 3 | Active comparator | Drug: ivermectinivermectin treatment |
| 4 | Active comparator | Drug: albendazole + ivermectinalbendazole + ivermectin treatment |
| 5 | Active comparator | Drug: mebendazole + ivermectinmebendazole + ivermectin treatment |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Those who are enrolled in class one to six
- Are infected with T. trichiura
- Whose parent consent and who are willing to participate
Key exclusion criteria (2 listed)
- Those with acute and chronic diseases other than T. trichiura
- Those with a history of any serious adverse drug reactions
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 |
|---|---|---|
| albendazolealbendazole (400 mg on dose) | Drug | 1 |
| mebendazolemebendazole (500 mg one dose) | Drug | 2 |
| ivermectinivermectin (200 microgram/kg body weight) | Drug | 3 |
| albendazole + ivermectinalbendazole (400 mg one dose) + ivermectin (200 mg microgram/kg body weight) | Drug | 4 |
| mebendazole + ivermectinmebendazole (500 mg one dose) + ivermectin (200 microgram/kg body weight) | Drug | 5 |
Primary outcome
Record adverse reactions
Time frame: 6 weeks
1 secondary outcome
Efficacy of treatment
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2010.
- Derived from this study: PubMed 21885077Namwanje H, Kabatereine NB, Olsen A. Efficacy of single and double doses of albendazole and mebendazole alone and in combination in the treatment of Trichuris trichiura in school-age children in Uganda. Trans R Soc Trop Med Hyg. 2011 Oct;105(10):586-90. doi: 10.1016/j.trstmh.2011.07.009. Epub 2011 Aug 31.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing albendazole, mebendazole and ivermectin in people with Parasitic Diseases, run by DBL -Institute for Health Research and Development at 1 site in Uganda.
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 3 inclusion and 2 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 15 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Record adverse reactions (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01050452, which also lists 1 linked publication.
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 15 Jan 2010.