Rotavirus InfectionPhase 2NCT01328925
Efficacy Study of Nitazoxanide Suspension in the Treatment of Rotavirus Disease in Children
A Phase 2 study testing Nitazoxanide in people with Rotavirus Infection and Viral Gastroenteritis Due to Rotavirus, run by Romark Laboratories L.C. at 1 site in Egypt.
Trial summary
The purpose of this study is to determine the effectiveness of nitazoxanide suspension compared to placebo in treating rotavirus disease in pediatric patients less than 6 years of age. Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Rotavirus Infection, Viral Gastroenteritis Due to Rotavirus
- 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 siteEgypt
- Study dates
- Dec 2005to Jun 2006
- Phase
- Phase 2
- 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 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age < 6 years.
- Patients with diarrhea (defined as 3 or more liquid stools per day).
- Stool positive for rotavirus by ELISA.
Who cannot join
- Other identified causes of diarrhea at screening (pathogenic protozoa, bacteria, viruses or lactose intolerance).
- Serious systemic disorders incompatible with the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind, Placebo-controlled Study of Nitazoxanide Suspension in the Treatment of Rotavirus Disease in Children
The purpose of this study is to determine the effectiveness of nitazoxanide suspension compared to placebo in treating rotavirus disease in pediatric patients less than 6 years of age.
- Being tested
- Nitazoxanide
- Keywords
- Rotavirus, Viral gastroenteritis, Gastroenteritis
- Medical subject headings
- Rotavirus Infections, Gastroenteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NitazoxanideDrug
Also called Alinia, NTZ
Nitazoxanide Oral Suspension dose based on age:
Age <12 months- 7.5 mg/kg by mouth twice daily for 3 days; Age 12-47 months- 100 mg/5 ml by mouth twice daily for 3 days; Age 48-72 months- 200 mg/10 ml by mouth twice daily for 3 days
| Study group | Role | What they receive |
|---|---|---|
| Nitazoxanide Oral Suspension | Experimental | Nitazoxanide Oral Suspension 100 mg/5 ml Receives: Drug: Nitazoxanide |
| Placebo Oral Suspension | Placebo comparator | Placebo Oral Suspension 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 all gastrointestinal symptoms associated with viral 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 48 hours to be considered valid.
Measured: Up to 14 days
Secondary outcomes (5)
Time from first dose to virologic response
Daily stool samples will be analyzed by ELISA for the presence of rotavirus. Virologic response is defined by a negative ELISA stool test for rotavirus on 2 consecutive days.
Measured: Up to 14 days
Time from first dose to hospital discharge
For hospitalized patients, the study will monitor the time in hours from the first dose of study medication to discharge from the hospital.
Measured: Up to 14 days
Volume of oral rehydration solutions consumed
Measured: Up to 14 days
Frequency of intravenous rehydration required
Measured: Up to 14 days
Stool weight
Measured: Up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2011 (estimated)
- Study startDec 2005
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 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
- Mona Abu-Zekry, MD, Principal investigator, Cairo University Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01328925
- Sponsor's protocol ID
- RM02-3022
- Status last verified
- Apr 2011
- First submitted
- 29 Mar 2011
- Last updated
- 5 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Placebo-controlled Study of Nitazoxanide Suspension in the Treatment of Rotavirus Disease in Children
- ClinicalTrials.gov ID
- NCT01328925
- Acronym / sponsor ID
- RM02-3022
- Keywords
- Rotavirus, Viral gastroenteritis, Gastroenteritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Romark Laboratories L.C.Industry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 5 Apr 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 is to determine the effectiveness of nitazoxanide suspension compared to placebo in treating rotavirus disease in pediatric patients less than 6 years of age.
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 Oral Suspension | Experimental | Drug: NitazoxanideNitazoxanide Oral Suspension 100 mg/5 ml |
| Placebo Oral Suspension | Placebo comparator | Drug: NitazoxanidePlacebo Oral Suspension |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age < 6 years.
- Patients with diarrhea (defined as 3 or more liquid stools per day).
- Stool positive for rotavirus by ELISA.
Key exclusion criteria (2 listed)
- Other identified causes of diarrhea at screening (pathogenic protozoa, bacteria, viruses or lactose intolerance).
- 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 |
|---|---|---|
| NitazoxanideAlso: Alinia, NTZNitazoxanide Oral Suspension dose based on age: Age <12 months- 7.5 mg/kg by mouth twice daily for 3 days; Age 12-47 months- 100 mg/5 ml by mouth twice daily for 3 days; Age 48-72 months- 200 mg/10 ml by mouth twice daily for 3 days | Drug | Nitazoxanide Oral Suspension, Placebo Oral Suspension |
Primary outcome
Time from first dose to resolution of symptoms.
Time frame: Up to 14 days
Resolution of all gastrointestinal symptoms associated with viral 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 48 hours to be considered valid.
5 secondary outcomes
Time from first dose to virologic response
Time frame: Up to 14 days
Time from first dose to hospital discharge
Time frame: Up to 14 days
Volume of oral rehydration solutions consumed
Time frame: Up to 14 days
Frequency of intravenous rehydration required
Time frame: Up to 14 days
Stool weight
Time frame: Up to 14 days
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 5 Apr 2011.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nitazoxanide in people with Rotavirus Infection and Viral Gastroenteritis Due to Rotavirus, run by Romark Laboratories L.C. at 1 site 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 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 5 Apr 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 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 14 days). 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 5 Apr 2011.