DiarrheaPhase 3NCT01326338
Nitazoxanide for the Treatment of Prolonged Diarrhea in Children
A Phase 3 study testing Nitazoxanide in people with Diarrhea, run by Romark Laboratories L.C. at 1 site in Peru.
Trial summary
The purpose of this study was to determine the efficacy of nitazoxanide suspension compared to placebo in treating prolonged diarrhea in children. Read more about this study
- Who is it for?
- Ages 12 months to 11 years
- Conditions the study is for
- Diarrhea
- What is being tested?
- Nitazoxanide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 sitePeru
- Study dates
- Mar 2005to May 2006
- 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 months to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients with diarrhea ≥3 days but <30 days duration.
- No visible blood in stool.
Who cannot join
- Use of any antibacterial, antiparasitic or antiviral drugs within 5 days of enrollment.
- 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 according to the investigator's judgment.
- Patients known to have or suspected of having AIDS or other immune deficiencies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-Center, Double-Blind, Placebo-Controlled Study of Nitazoxanide Suspension in the Treatment of Prolonged Diarrhea in Children
The purpose of this study was to determine the efficacy of nitazoxanide suspension compared to placebo in treating prolonged diarrhea in children.
- Conditions
- Diarrhea
- Being tested
- Nitazoxanide
- Keywords
- Diarrhea
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NitazoxanideDrug
Also called Alinia
Nitazoxanide Oral Suspension 100 mg/5 ml for patients aged 1-3 years twice daily for 3 days or Nitazoxanide Oral Suspension 200 mg/10 ml for patients aged 4-11 years twice daily for 3 days
| Study group | Role | What they receive |
|---|---|---|
| Nitazoxanide Suspension | Experimental | Nitazoxanide Oral Suspension 100 mg/5 ml for patients aged 1-3 years or Nitazoxanide Oral Suspension 200 mg/10 ml for patients aged 4-11 years Receives: Drug: Nitazoxanide |
| Placebo Suspension | Placebo comparator | Placebo Oral Suspension 5 ml for patients aged 1-3 years and Placebo Oral Suspension 10 ml for patients aged 4-11 years Receives: Drug: Nitazoxanide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from first dose to resolution of symptoms
Resolution of symptoms defined as resolution of all gastrointestinal symptoms associated with prolonged diarrhea at enrollment including abdominal pain or tenderness, distention, etc. with the patient not requiring anti-motility or other palliative treatment. Symptom resolution must be maintained for at least 72 hours to be considered valid.
Measured: Up to 17 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2011 (estimated)
- Study startMar 2005
- Primary completionMay 2006
- Study completionMay 2006
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 DiarrheaStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Romark Laboratories L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Nicolas Lopez, MD, Principal investigator, Regional Hospital of Cajamarca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01326338
- Sponsor's protocol ID
- RM02-3019
- Status last verified
- Mar 2011
- First submitted
- 28 Mar 2011
- Last updated
- 30 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Rossignol JF, Lopez-Chegne N, Julcamoro LM, Carrion ME, Bardin MC. Nitazoxanide for the empiric treatment of pediatric infectious diarrhea. Trans R Soc Trop Med Hyg. 2012 Mar;106(3):167-73. doi: 10.1016/j.trstmh.2011.11.007. Epub 2012 Jan 31.
PubMed 22301075
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center, Double-Blind, Placebo-Controlled Study of Nitazoxanide Suspension in the Treatment of Prolonged Diarrhea in Children
- ClinicalTrials.gov ID
- NCT01326338
- Acronym / sponsor ID
- RM02-3019
- Conditions
- Diarrhea
- Keywords
- Diarrhea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Romark Laboratories L.C.Industry (pharma, biotech, devices)
- Study start
- Mar 2005
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 30 Mar 2011 (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 was to determine the efficacy of nitazoxanide suspension compared to placebo in treating prolonged diarrhea in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nitazoxanide Suspension | Experimental | Drug: NitazoxanideNitazoxanide Oral Suspension 100 mg/5 ml for patients aged 1-3 years or Nitazoxanide Oral Suspension 200 mg/10 ml for patients aged 4-11 years |
| Placebo Suspension | Placebo comparator | Drug: NitazoxanidePlacebo Oral Suspension 5 ml for patients aged 1-3 years and Placebo Oral Suspension 10 ml for patients aged 4-11 years |
Who may qualify
- Ages
- 12 months to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients with diarrhea ≥3 days but <30 days duration.
- No visible blood in stool.
Key exclusion criteria (6 listed)
- Use of any antibacterial, antiparasitic or antiviral drugs within 5 days of enrollment.
- 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 according to the investigator's judgment.
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 |
|---|---|---|
| NitazoxanideAlso: AliniaNitazoxanide Oral Suspension 100 mg/5 ml for patients aged 1-3 years twice daily for 3 days or Nitazoxanide Oral Suspension 200 mg/10 ml for patients aged 4-11 years twice daily for 3 days | Drug | Nitazoxanide Suspension, Placebo Suspension |
Primary outcome
Time from first dose to resolution of symptoms
Time frame: Up to 17 days
Resolution of symptoms defined as resolution of all gastrointestinal symptoms associated with prolonged diarrhea at enrollment including abdominal pain or tenderness, distention, etc. with the patient not requiring anti-motility or other palliative treatment. Symptom resolution must be maintained for at least 72 hours to be considered valid.
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 30 Mar 2011.
- Derived from this study: PubMed 22301075Rossignol JF, Lopez-Chegne N, Julcamoro LM, Carrion ME, Bardin MC. Nitazoxanide for the empiric treatment of pediatric infectious diarrhea. Trans R Soc Trop Med Hyg. 2012 Mar;106(3):167-73. doi: 10.1016/j.trstmh.2011.11.007. Epub 2012 Jan 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.
Nicolas Lopez, MD principal investigator
Regional Hospital of Cajamarca
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 Nitazoxanide in people with Diarrhea, run by Romark Laboratories L.C. at 1 site in Peru.
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 2 inclusion and 6 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 30 Mar 2011. 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 Peru. 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?
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?
Time from first dose to resolution of symptoms (time frame: Up to 17 days). 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 NCT01326338, 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 30 Mar 2011.