Rotavirus InfectionPhase 2/3NCT00302640
Study of Nitazoxanide Suspension in the Treatment of Diarrhea Caused by Enteric Viruses in Children
A Phase 2/3 study testing Alinia (nitazoxanide) in people with Rotavirus Infection and Adenoviridae Infection, run by Romark Laboratories L.C..
Trial summary
The purpose of this study is to determine the effect of nitazoxanide suspension in treating diarrhea caused by enteric viruses in children less than 12 years of age. Read more about this study
- Who is it for?
- Ages Up to 11 years
- Conditions the study is for
- Rotavirus Infection, Adenoviridae Infection, Norovirus Infection
- What is being tested?
- Alinia (nitazoxanide)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Feb 2005to Sep 2005
- Phase
- Phase 2/3
- 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 Up to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age <12 years.
- Patients with diarrhea (defined as 3 or more stools per day with liquid or semi-solid consistency, the number and consistency of stools being unusual for that person).
- Stool positive for adenovirus, norovirus or rotavirus by ELISA.
Who cannot join
- Females who are pregnant, suspected of being pregnant or breastfeeding.
- Other identified causes of diarrhea at screening.
- Serious systemic disorders incompatible with the study.
About this study
Official title: Multi-center, Double-blind, Placebo-controlled Study of Nitazoxanide Suspension in the Treatment of Diarrhea Caused by Enteric Viruses in Children
The purpose of this study is to determine the effect of nitazoxanide suspension in treating diarrhea caused by enteric viruses in children less than 12 years of age.
- Being tested
- Alinia (nitazoxanide)
- Medical subject headings
- Rotavirus Infections, Adenoviridae Infections, Caliciviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alinia (nitazoxanide)Drug
| Study group | Role | What they receive |
|---|---|---|
| Nitazoxanide | Active comparator | 7.5mg/kg (age under 12 months), 5 mL (100mg nitazoxanide; age 1-3 years), 10 mL (200mg nitazoxanide; age 4-11 years) twice daily x 3 days Receives: Drug: Alinia (nitazoxanide) |
| Placebo | Placebo comparator | 7.5mg/kg (age under 12 months), 5 mL (100mg nitazoxanide; age 1-3 years), 10 mL (200mg nitazoxanide; age 4-11 years) twice daily x 3 days Receives: Drug: Alinia (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.
Median time: 31 hours for nitazoxanide group and 75 hours for the placebo group
Measured: P-0.0105
Secondary outcomes (1)
Virologic response (negative ELISA) at day 7-10.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2006 (estimated)
- Study startFeb 2005
- Study completionSep 2005
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 Rotavirus 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Romark Laboratories L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mona Abu-Zekry, MD, Principal investigator, Cairo University Children's Hospital, Cairo, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00302640
- Sponsor's protocol ID
- RM02-3021
- Status last verified
- May 2012
- First submitted
- 13 Mar 2006
- Last updated
- 31 May 2012
- Results posted
- No
Publications
Rossignol JF, Abu-Zekry M, Hussein A, Santoro MG. Effect of nitazoxanide for treatment of severe rotavirus diarrhoea: randomised double-blind placebo-controlled trial. Lancet. 2006 Jul 8;368(9530):124-9. doi: 10.1016/S0140-6736(06)68852-1.
PubMed 16829296
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2012. 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 Diarrhea Caused by Enteric Viruses in Children
- ClinicalTrials.gov ID
- NCT00302640
- Acronym / sponsor ID
- RM02-3021
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Romark Laboratories L.C.Industry (pharma, biotech, devices)
- Study start
- Feb 2005
- Study completion
- Sep 2005
- First posted
- 14 Mar 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 suspension in treating diarrhea caused by enteric viruses in children less than 12 years of age.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nitazoxanide | Active comparator | Drug: Alinia (nitazoxanide)7.5mg/kg (age under 12 months), 5 mL (100mg nitazoxanide; age 1-3 years), 10 mL (200mg nitazoxanide; age 4-11 years) twice daily x 3 days |
| Placebo | Placebo comparator | Drug: Alinia (nitazoxanide)7.5mg/kg (age under 12 months), 5 mL (100mg nitazoxanide; age 1-3 years), 10 mL (200mg nitazoxanide; age 4-11 years) twice daily x 3 days |
Who may qualify
- Ages
- Up to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age <12 years.
- Patients with diarrhea (defined as 3 or more stools per day with liquid or semi-solid consistency, the number and consistency of stools being unusual for that person).
- Stool positive for adenovirus, norovirus or rotavirus by ELISA.
Key exclusion criteria (3 listed)
- Females who are pregnant, suspected of being pregnant or breastfeeding.
- Other identified causes of diarrhea at screening.
- Serious systemic disorders incompatible with the study.
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 |
|---|---|---|
| Alinia (nitazoxanide) | Drug | Nitazoxanide, Placebo |
Primary outcome
Time from first dose to resolution of symptoms.
Time frame: P-0.0105
Median time: 31 hours for nitazoxanide group and 75 hours for the placebo group
1 secondary outcome
Virologic response (negative ELISA) at day 7-10.
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 31 May 2012.
- Results publication: PubMed 16829296Rossignol JF, Abu-Zekry M, Hussein A, Santoro MG. Effect of nitazoxanide for treatment of severe rotavirus diarrhoea: randomised double-blind placebo-controlled trial. Lancet. 2006 Jul 8;368(9530):124-9. doi: 10.1016/S0140-6736(06)68852-1.
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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.
Mona Abu-Zekry, MD principal investigator
Cairo University Children's Hospital, Cairo, Egypt
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Alinia (nitazoxanide) in people with Rotavirus Infection and Adenoviridae Infection, run by Romark Laboratories L.C..
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 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 31 May 2012. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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: P-0.0105). 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 NCT00302640, 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 31 May 2012.