Chronic StrongyloidiasisPhase 3NCT00765024
Ivermectin Versus Albendazole for Chronic Strongyloidiasis
A Phase 3 study testing Ivermectin and Albendazole in people with Chronic Strongyloidiasis, run by Mahidol University at 1 site in Thailand.
Trial summary
A prospective controlled trial to compare the efficacy and safety of 7-day albendazole, single dose ivermectin, and 2-single dose ivermectin in 72 patients with chronic strongyloidiasis will be conducted at Siriraj Hospital, Bangkok, Thailand. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Strongyloidiasis
- What is being tested?
- Ivermectin and Albendazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteThailand
- Study dates
- Jul 2008to Apr 2010
- Phase
- Phase 3
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with positive strongyloides larva in the stool
Who cannot join
- Pregnancy
- Lactating women
- Known allergy to any study drug
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Ivermectin Versus Albendazole for Chronic Strongyloidiasis
A prospective controlled trial to compare the efficacy and safety of 7-day albendazole, single dose ivermectin, and 2-single dose ivermectin in 72 patients with chronic strongyloidiasis will be conducted at Siriraj Hospital, Bangkok, Thailand.
- Conditions
- Chronic Strongyloidiasis
- Being tested
- Ivermectin, Albendazole
- Keywords
- strongyloidiasis, ivermectin, albendazole
- Medical subject headings
- Strongyloidiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvermectinDrug
Also called stromectal
single dose of 200 mcg/kg
ivermectinDrug
Also called stromectal
two single dose of 200mcg/kg in 2 weeks
AlbendazoleDrug
Albendazole 7 days
| Study group | Role | What they receive |
|---|---|---|
| Albendazole | Active comparator | Albendazole for 7 days Receives: Drug: Albendazole |
| ivermectin | Experimental | ivermectin 200 mcg/kg single dose Receives: Drug: Ivermectin |
| ivermectin 2 doses | Experimental | ivermectin 200 mcg/kg two doses in 2 weeks Receives: Drug: ivermectin |
What is being measured
The primary outcome is the main question the study is designed to answer.
cure rate
Measured: 1 year
Secondary outcomes (1)
safety
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2008 (estimated)
- Study startJul 2008
- Primary completionApr 2010
- Study completionApr 2010
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 Chronic StrongyloidiasisStudies 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
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- Atlantic Laboratory Ltd
- Responsible party
- Sponsor
- Investigators
- Yupin Suputtamongkol, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00765024
- Sponsor's protocol ID
- TM001-2008
- Status last verified
- Sep 2017
- First submitted
- 30 Sep 2008
- Last updated
- 7 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Suputtamongkol Y, Premasathian N, Bhumimuang K, Waywa D, Nilganuwong S, Karuphong E, Anekthananon T, Wanachiwanawin D, Silpasakorn S. Efficacy and safety of single and double doses of ivermectin versus 7-day high dose albendazole for chronic strongyloidiasis. PLoS Negl Trop Dis. 2011 May 10;5(5):e1044. doi: 10.1371/journal.pntd.0001044.
PubMed 21572981
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Ivermectin Versus Albendazole for Chronic Strongyloidiasis
- ClinicalTrials.gov ID
- NCT00765024
- Acronym / sponsor ID
- TM001-2008
- Conditions
- Chronic Strongyloidiasis
- Keywords
- strongyloidiasis, ivermectin, albendazole
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- Atlantic Laboratory Ltd
- Study start
- Jul 2008 (actual)
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 2 Oct 2008 (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.
A prospective controlled trial to compare the efficacy and safety of 7-day albendazole, single dose ivermectin, and 2-single dose ivermectin in 72 patients with chronic strongyloidiasis will be conducted at Siriraj Hospital, Bangkok, Thailand.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Albendazole | Active comparator | Drug: AlbendazoleAlbendazole for 7 days |
| ivermectin | Experimental | Drug: Ivermectinivermectin 200 mcg/kg single dose |
| ivermectin 2 doses | Experimental | Drug: ivermectinivermectin 200 mcg/kg two doses in 2 weeks |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with positive strongyloides larva in the stool
Key exclusion criteria (3 listed)
- Pregnancy
- Lactating women
- Known allergy to any study drug
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 |
|---|---|---|
| IvermectinAlso: stromectalsingle dose of 200 mcg/kg | Drug | ivermectin |
| ivermectinAlso: stromectaltwo single dose of 200mcg/kg in 2 weeks | Drug | ivermectin 2 doses |
| AlbendazoleAlbendazole 7 days | Drug | Albendazole |
Primary outcome
cure rate
Time frame: 1 year
1 secondary outcome
safety
Time frame: 1 year
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 7 Sep 2017.
- Derived from this study: PubMed 21572981Suputtamongkol Y, Premasathian N, Bhumimuang K, Waywa D, Nilganuwong S, Karuphong E, Anekthananon T, Wanachiwanawin D, Silpasakorn S. Efficacy and safety of single and double doses of ivermectin versus 7-day high dose albendazole for chronic strongyloidiasis. PLoS Negl Trop Dis. 2011 May 10;5(5):e1044. doi: 10.1371/journal.pntd.0001044.
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.
Yupin Suputtamongkol, MD principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ivermectin and Albendazole in people with Chronic Strongyloidiasis, run by Mahidol University at 1 site in Thailand.
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 7 Sep 2017. 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 Thailand. 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. 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?
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?
cure rate (time frame: 1 year). 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 NCT00765024, 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 7 Sep 2017.