Schistosoma Hematobium InfectionPhase 3PHAR0211NCT01529710
Safety and Efficacy of Mirazid for Schistosomiasis Treatment
A Phase 3 study testing Myrrh in people with Schistosoma Hematobium Infection and Schistosomiasis Mansoni, run by Pharco Pharmaceuticals at 2 sites in Egypt.
Trial summary
Clinical Trial Phase:Phase III Primary Objectives: Compare Mirazid and Praziquantel cure rates for both Schistosoma species. Compare Mirazid and Praziquantel effect in lowering the intensity of infection for both Schistosoma species. Read more about this study
- Who is it for?
- Ages 15 to 30 years
- Conditions the study is for
- Schistosoma Hematobium Infection, Schistosomiasis Mansoni
- What is being tested?
- Myrrh
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesEgypt
- Study dates
- Dec 2011to Sep 2012
- 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 15 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescent and young adults aged 15-30 years
- Positive for Schistosoma infection of any type.
Who cannot join
- Mixed Schistosoma infection of both types
- History of administration of treatment for Schistosoma infection in the last 6 months prior to the study.
- Severely ill patients
- Advanced chronic liver disease.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Safety and Efficacy of Mirazid for Schistosomiasis Treatment as Compared to Praziquantel: An Open-label Randomized Non-placebo-Controlled Study
Clinical Trial Phase:Phase III
Primary Objectives:
Read more
- Compare Mirazid and Praziquantel cure rates for both Schistosoma species.
- Compare Mirazid and Praziquantel effect in lowering the intensity of infection for both Schistosoma species.
Secondary Objective:Identify and compare the types and severity of side and adverse effects between the Mirazid and Praziquantel.
Study Population:200 Schistosomiasis infected persons of both types of Schistosomiasis aged from 15-35 years. Those subjects will be selected from among those screened.Subjects will include both genders excluding chronically ill such as chronic liver disease patients and those with both types of Schistosomiasis.
Recruitment Period:3 months and subjects follow up for another 3 months followed by 3 months for statistical analysis and report writing Study Duration: Total study duration is expected to be 9 months: 3 months for recruitment, 3 months for follow up and 3 months for data management and report writing.
Endpoints: Will be measured at 3 months of successful administration of treatment either Mirazid or Praziquantel as per the randomization scheme. By then, final assessment of the response to treatment will be done by examining urine or stool of the subject for presence of Schistosoma eggs and its density if found.
Three negative urine or stool samples collected 2-days apart at 12 weeks post treatment will indicate treatment success. One positive sample collected at week 12 will indicate infection with Schistosomiasis.
Read the detailed description
Study Design:This is a phase III, open-label randomized non-placebo-controlled Study in which the investigators will compare the efficacy and safety of Mirazid to Praziquantel as a treatment for Schistosomiasis. After screening, positive subjects for one of the Schistosomiasis will be recruited in the study. They will be treated by Mirazid as 600 mg oral (Soft Gelatin Capsules) for 6 consecutive days or 40mg/Kg body weight of Praziquantel as a single oral dose. Subjects will be evaluated for success of treatment at 12 weeks of treatment. Evaluation will be done by examining urine or stool samples for Schistosomiasis including egg counts for the positive cases.
- Being tested
- Myrrh
- Keywords
- Schistosomiasis hematobium, Schistosomiasis mansoni
- Medical subject headings
- Schistosomiasis haematobia, Schistosomiasis mansoni
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyrrhDrug
Also called Mirazid, Praziquantel, Shistosomiasis, Oral
Subjects will be treated by Mirazid as 600 mg oral (Soft Gelatin Capsules) for 6 consecutive days or 40mg/Kg body weight of Praziquantel as a single oral dose. Subjects will be evaluated for success of treatment at 12 weeks of treatment. Evaluation will be done by examining urine or stool samples for Schistosomiasis including egg counts for the positive cases.
| Study group | Role | What they receive |
|---|---|---|
| Mirazid | Experimental | Mirazid is an antischistosomal drug available in the local Egyptian market since 2001 (Mirazid®). It originates from Myrrh a medicinal herb that has been used for thousands of years. Myrrh (Arabian or Somali Myrrh) is an oleo-gum resin, obtained from the stem of various species of Commiphora (Burseraceae) growing in northeast Africa and Arabia. Receives: Drug: Myrrh |
| Praziquantel | Active comparator | Tablets Receives: Drug: Myrrh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare Mirazid and Praziquantel cure rates for both Schistosoma species, and effect in lowering the intensity of infection for both Schistosoma species.
Measured: 9 months
Secondary outcomes (1)
Identify and compare the types and severity of side and adverse effects between the Mirazid and Praziquantel.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2012 (estimated)
- Study startDec 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schistosoma Hematobium 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharco Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ayat A Haggag, MD, Principal investigator, Ministry of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01529710
- Sponsor's protocol ID
- Mirazid2012
- Acronym
- PHAR0211
- Status last verified
- Feb 2015
- First submitted
- 6 Feb 2012
- Last updated
- 20 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Mirazid for Schistosomiasis Treatment as Compared to Praziquantel: An Open-label Randomized Non-placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT01529710
- Acronym / sponsor ID
- PHAR0211 / Mirazid2012
- Keywords
- Schistosomiasis hematobium, Schistosomiasis mansoni
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Pharco PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 9 Feb 2012 (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.
Clinical Trial Phase:Phase III
Primary Objectives:
- Compare Mirazid and Praziquantel cure rates for both Schistosoma species.
- Compare Mirazid and Praziquantel effect in lowering the intensity of infection for both Schistosoma species.
Secondary Objective:Identify and compare the types and severity of side and adverse effects between the Mirazid and Praziquantel.
Study Population:200 Schistosomiasis infected persons of both types of Schistosomiasis aged from 15-35 years. Those subjects will be selected from among those screened.Subjects will include both genders excluding chronically ill such as chronic liver disease patients and those with both types of Schistosomiasis.
Recruitment Period:3 months and subjects follow up for another 3 months followed by 3 months for statistical analysis and report writing Study Duration: Total study duration is expected to be 9 months: 3 months for recruitment, 3 months for follow up and 3 months for data management and report writing.
Endpoints: Will be measured at 3 months of successful administration of treatment either Mirazid or Praziquantel as per the randomization scheme. By then, final assessment of the response to treatment will be done by examining urine or stool of the subject for presence of Schistosoma eggs and its density if found.
Three negative urine or stool samples collected 2-days apart at 12 weeks post treatment will indicate treatment success. One positive sample collected at week 12 will indicate infection with Schistosomiasis.
Detailed description
Study Design:This is a phase III, open-label randomized non-placebo-controlled Study in which the investigators will compare the efficacy and safety of Mirazid to Praziquantel as a treatment for Schistosomiasis. After screening, positive subjects for one of the Schistosomiasis will be recruited in the study. They will be treated by Mirazid as 600 mg oral (Soft Gelatin Capsules) for 6 consecutive days or 40mg/Kg body weight of Praziquantel as a single oral dose. Subjects will be evaluated for success of treatment at 12 weeks of treatment. Evaluation will be done by examining urine or stool samples for Schistosomiasis including egg counts for the positive cases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mirazid | Experimental | Drug: MyrrhMirazid is an antischistosomal drug available in the local Egyptian market since 2001 (Mirazid®). It originates from Myrrh a medicinal herb that has been used for thousands of years. Myrrh (Arabian or Somali Myrrh) is an oleo-gum resin, obtained from the stem of various species of Commiphora (Burseraceae) growing in northeast Africa and Arabia. |
| Praziquantel | Active comparator | Drug: MyrrhTablets |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Adolescent and young adults aged 15-30 years
- Positive for Schistosoma infection of any type.
Key exclusion criteria (4 listed)
- Mixed Schistosoma infection of both types
- History of administration of treatment for Schistosoma infection in the last 6 months prior to the study.
- Severely ill patients
- Advanced chronic liver disease.
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 |
|---|---|---|
| MyrrhAlso: Mirazid, Praziquantel, Shistosomiasis, OralSubjects will be treated by Mirazid as 600 mg oral (Soft Gelatin Capsules) for 6 consecutive days or 40mg/Kg body weight of Praziquantel as a single oral dose. Subjects will be evaluated for success of treatment at 12 weeks of treatment. Evaluation will be done by examining urine or stool samples for Schistosomiasis including egg counts for the positive cases. | Drug | Mirazid, Praziquantel |
Primary outcome
Compare Mirazid and Praziquantel cure rates for both Schistosoma species, and effect in lowering the intensity of infection for both Schistosoma species.
Time frame: 9 months
1 secondary outcome
Identify and compare the types and severity of side and adverse effects between the Mirazid and Praziquantel.
Time frame: 9 months
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 20 Feb 2015.
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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.
Ayat A Haggag, MD principal investigator
Ministry of Health
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 Myrrh in people with Schistosoma Hematobium Infection and Schistosomiasis Mansoni, run by Pharco Pharmaceuticals 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 2 inclusion and 4 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 20 Feb 2015. 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?
Compare Mirazid and Praziquantel cure rates for both Schistosoma species, and effect in lowering the intensity of infection for both Schistosoma species. (time frame: 9 months). 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 20 Feb 2015.