AmebiasisPhase 3NCT00366236
Study of Nitazoxanide in the Treatment of Amebiasis in Adults and Adolescents
A Phase 3 study testing Nitazoxanide in people with Amebiasis, run by Romark Laboratories L.C. at 2 sites in Egypt.
Trial summary
The purpose of this study is to determine the effect of nitazoxanide tablets in treating diarrhea caused by Entamoeba histolytica in adults and adolescents. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Amebiasis
- What is being tested?
- Nitazoxanide
- How many people
- 50 participants
- Where
- 2 sitesEgypt
- Study dates
- Feb 2004to Nov 2005
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥12 years.
- Patients with diarrhea (≥3 bowel movements/day) with one or more enteric symptoms such as bloody stools, rectal bleeding or enlarged colon.
- Positive stool ELISA test for Entamoeba histolytica within 7 days prior to enrollment.
Who cannot join
- Patients with identified causes of diarrhea other than E. histolytica.
- Use within 2 weeks of enrollment of any drug or therapy with possible anti-protozoal activity.
- Females who are pregnant, suspected of being pregnant or breastfeeding.
- Serious systemic disorders incompatible with the study.
- History of hypersensitivity to nitazoxanide.
- Patients in whom the possibility of receiving placebo and not being able to receive immediately an effective treatment will be incompatible with the severity of the patient's illness.
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- Patients with amebic liver abscess.
- Patients known to have or suspected of having AIDS.
- Patient with immune deficiencies.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Multi-Center, Double-Blind, Placebo-Controlled Study of Nitazoxanide Tablets in the Treatment of Diarrhea Caused by Entamoeba Histolytica in Adults and Adolescents
The purpose of this study is to determine the effect of nitazoxanide tablets in treating diarrhea caused by Entamoeba histolytica in adults and adolescents.
- Conditions
- Amebiasis
- Being tested
- Nitazoxanide
- Keywords
- Amebiasis, Entamoeba histolytica
- Medical subject headings
- Amebiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NitazoxanideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of clinical symptoms of amebiasis
Secondary outcomes (2)
Eradication of cyst or trophozoites of E. histolytica from post-treatment stool samples
Time from initiation of treatment to passage of last unformed stool
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2006 (estimated)
- Study startFeb 2004
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmebiasisStudies 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
- Single group
- Masking
- Double blind
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Romark Laboratories L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Samir M Kabil, MD, Principal investigator, Benha UniversityYehia El-Gohary, MD, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00366236
- Sponsor's protocol ID
- RM01-3017
- Status last verified
- Aug 2006
- First submitted
- 18 Aug 2006
- Last updated
- 21 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center, Double-Blind, Placebo-Controlled Study of Nitazoxanide Tablets in the Treatment of Diarrhea Caused by Entamoeba Histolytica in Adults and Adolescents
- ClinicalTrials.gov ID
- NCT00366236
- Acronym / sponsor ID
- RM01-3017
- Conditions
- Amebiasis
- Keywords
- Amebiasis, Entamoeba histolytica
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- Romark Laboratories L.C.Industry (pharma, biotech, devices)
- Study start
- Feb 2004
- Study completion
- Nov 2005
- First posted
- 21 Aug 2006 (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.
The purpose of this study is to determine the effect of nitazoxanide tablets in treating diarrhea caused by Entamoeba histolytica in adults and adolescents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥12 years.
- Patients with diarrhea (≥3 bowel movements/day) with one or more enteric symptoms such as bloody stools, rectal bleeding or enlarged colon.
- Positive stool ELISA test for Entamoeba histolytica within 7 days prior to enrollment.
Key exclusion criteria (9 listed)
- Patients with identified causes of diarrhea other than E. histolytica.
- Use within 2 weeks of enrollment of any drug or therapy with possible anti-protozoal activity.
- Females who are pregnant, suspected of being pregnant or breastfeeding.
- Serious systemic disorders incompatible with the study.
- History of hypersensitivity to nitazoxanide.
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 |
|---|---|---|
| Nitazoxanide | Drug | – |
Primary outcome
Resolution of clinical symptoms of amebiasis
2 secondary outcomes
Eradication of cyst or trophozoites of E. histolytica from post-treatment stool samples
Time from initiation of treatment to passage of last unformed stool
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 21 Aug 2006.
Related trials for Amebiasis
RecruitingPhase 3
Parasitic Ulcer Treatment Trial
Acanthamoeba Keratitis
Not yet recruitingPhase 3
Efficacy of Diloxanide Furoate as Additional Luminal Agent Along With Metronidazole for the Treatment of Amoebic Liver Abscess
Liver Abscess, Amoebic Liver Abscess
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.
Samir M Kabil, MD principal investigator
Benha University
Yehia El-Gohary, MD principal investigator
Alexandria University
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 Nitazoxanide in people with Amebiasis, run by Romark Laboratories L.C. at 2 sites in Egypt.
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 9 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 21 Aug 2006. 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 Egypt. 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?
Resolution of clinical symptoms of amebiasis. 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 21 Aug 2006.