HelminthiasisPhase 4NCT02385058
Study to Evaluate Efficacy and Safety of a Double Treatment Plan Using a Combination of Mebendazole and Quinfamide for Treating Intestinal Helminthiasis and Amebiasis in the Mexican Population
A Phase 4 study testing Mebendazole and Quinfamide in people with Helminthiasis and Amoebiasis, run by Janssen-Cilag Ltd. at 1 site in Mexico.
Trial summary
The purpose of this study is to assess the efficacy and safety of the combination of mebendazole plus quinfamide for the treatment of intestinal helminthiasis and amoebiasis in Mexican population. Read more about this study
- Who is it for?
- Ages 10 to 75 years
- Conditions the study is for
- Helminthiasis, Amoebiasis
- What is being tested?
- Mebendazole and Quinfamide
- 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 siteMexico
- Study dates
- Oct 2005to Jan 2006
- Phase
- Phase 4
- 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 10 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Minors whose parents or tutor grant his/her informed consent in writing to participate in the study. Adult participants that give their informed consent in writing to participate
- Participants having a copro-parasitoscopy test (scatology) (at least 1 with a series of 3) qualitative and quantitative and/or search of live amoeba, that comes out positive for one or more of the following parasites: Ascaris lumbricoides, Enterobius vermicularis, Trichuris trichuria, Taenia solium, Necator americanus, Ancylostoma duodenale and Trophozoites of Entamoeba histolytica
- With at least two or more of the following symptoms: Anorexia, Nausea, Vomit, Abdominal pain, Diarrhea, Constipation, Evacuations with mucus, Evacuations with blood, Gas discharge, Weight loss and Bruxism
Who cannot join
- Participants with any known allergy to any of the drugs used in the investigation
- Female Participant in reproductive age not using an adequate contraceptive method
- Pregnant or lactating Participant
- Participant with any life-threatening condition (cancer, AIDS, etc.)
- Participant known to be a carrier of some illness that alters the metabolism or drug excretion (hepatic or renal illness) interfering with the absorption (malabsorption) or interferes with the evaluation of the Participant during the study
- Participants that have taken any antiparasitic drug 14 days previous to his/her inclusion in this clinical investigation protocol
- Participants with diagnosis of extra-intestinal amoebiasis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-Blind, Placebo-Controlled, Randomized, Prospective, Two-Stage, Two-Arm Study to Evaluate the Efficaciousness and Safety of a Double Treatment Plan Using a Combination of Mebendazole and Quinfamide for Treating Intestinal Helminthiasis and Amebiasis in the Mexican Population
The purpose of this study is to assess the efficacy and safety of the combination of mebendazole plus quinfamide for the treatment of intestinal helminthiasis and amoebiasis in Mexican population.
Read the detailed description
This is a double-blind (neither investigator nor participant knows which treatment the participant receives), placebo-controlled (placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial), randomized (study medication assigned to participants by chance), prospective (study following patients forward in time) study. The total study duration for each participant will be approximately 48 days. The study will consist of 3 parts: Screening Phase (5 days) and double-blind treatment Phase (from Day 1 to 21, consists of Phase-1 and Phase-2) and follow-up Phase (from Day 21 to 43). Participants will receive mebendazole (600 milligram [mg]) and quinfamide (200 mg) tablets orally once starting on Day 1 and mebendazole 600 mg and quinfamide (200 mg) or placebo tablets orally once starting on Day 21. Efficacy will be primarily evaluated by percentage of participants with eradication of helminthic and/or protozoa. Participants' safety will be monitored throughout the study.
- Conditions
- Helminthiasis, Amoebiasis
- Being tested
- Mebendazole, Quinfamide, Placebo
- Keywords
- Helminthiasis, Amoebiasis, Mebendazole, Quinfamide, Mexican population
- Medical subject headings
- Helminthiasis, Amebiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MebendazoleDrug
Mebendazole 600 milligram (mg) tablet orally once starting on Day 1 and 21.
QuinfamideDrug
Quinfamide 200 mg tablet orally once starting on Day 1 and 21.
PlaceboDrug
Placebo tablet orally once starting on Day 21.
| Study group | Role | What they receive |
|---|---|---|
| Mebendazole + Quinfamide | Experimental | Participants will receive mebendazole 600 milligram (mg) and quinfamide 200 mg tablets orally once starting on Day 1 and 21 in both Phase 1 and 2. Receives: Drug: Mebendazole; Drug: Quinfamide |
| Mebendazole + Quinfamide + Placebo | Experimental | Participants will receive mebendazole 600 mg and quinfamide 200 mg tablets orally once starting on Day 1 in Phase 1 and placebo tablets orally once starting on Day 21 in Phase 2. Receives: Drug: Mebendazole; Drug: Quinfamide; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Eradication of Helminthic and/or Protozoa (Trophozoites of Amoeba)
Participants must show the results of a negative copro-parasitoscopy exam and fresh amoeba test after the first and second treatment phase. Those participants presenting a positive result during the control exams will be considered as "Therapeutic failure".
Measured: Day 21
Percentage of Participants with Eradication of Helminthic and/or Protozoa (Trophozoites of Amoeba)
Participants must show the results of a negative copro-parasitoscopy exam and fresh amoeba test after the first and second treatment phase. Those participants presenting a positive result during the control exams will be considered as "Therapeutic failure".
Measured: Day 43
Secondary outcomes (3)
Percentage of Participants with Abdominal Symptoms Relieve
Evaluation of abdominal symptoms relief will be carried by the questionnaires, each one of the symptoms presence will be evaluated determining its presence or absence, intensity, and changes throughout the treatment period.
Measured: Day 43
Percentage of Participants with Improved Quality of Life
Evaluation of improved quality of life will be carried by the questionnaires, the results will be evaluated according to the symptomatic satisfaction scales, scale ranges from Excellent to Terrible (Excellent = very satisfied, Good= satisfied, Poor= more or less satisfied, Bad= unsatisfied and Terrible= very unsatisfied), which should show that there was an improvement in the sensation of wellbeing of the participant compared with the symptoms provoked by the presence of the intestinal parasitosis.
Measured: Day 43
Number of Participants with Adverse Events (AEs) and Serious AEs
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: Screening up to follow-up (Day 43)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2015 (estimated)
- Study startOct 2005
- Primary completionJan 2006
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HelminthiasisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag Ltd Clinical Trial, Study director, Janssen-Cilag Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02385058
- Sponsor's protocol ID
- CR003685
- Other IDs
- JC/AMO/REC/0605, MEBENDAZOLGAI3001
- Status last verified
- Apr 2015
- First submitted
- 5 Mar 2015
- Last updated
- 14 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Placebo-Controlled, Randomized, Prospective, Two-Stage, Two-Arm Study to Evaluate the Efficaciousness and Safety of a Double Treatment Plan Using a Combination of Mebendazole and Quinfamide for Treating Intestinal Helminthiasis and Amebiasis in the Mexican Population
- ClinicalTrials.gov ID
- NCT02385058
- Acronym / sponsor ID
- CR003685
- Conditions
- Helminthiasis, Amoebiasis
- Keywords
- Helminthiasis, Amoebiasis, Mebendazole, Quinfamide, Mexican population
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Janssen-Cilag Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 11 Mar 2015 (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 assess the efficacy and safety of the combination of mebendazole plus quinfamide for the treatment of intestinal helminthiasis and amoebiasis in Mexican population.
Detailed description
This is a double-blind (neither investigator nor participant knows which treatment the participant receives), placebo-controlled (placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial), randomized (study medication assigned to participants by chance), prospective (study following patients forward in time) study. The total study duration for each participant will be approximately 48 days. The study will consist of 3 parts: Screening Phase (5 days) and double-blind treatment Phase (from Day 1 to 21, consists of Phase-1 and Phase-2) and follow-up Phase (from Day 21 to 43). Participants will receive mebendazole (600 milligram [mg]) and quinfamide (200 mg) tablets orally once starting on Day 1 and mebendazole 600 mg and quinfamide (200 mg) or placebo tablets orally once starting on Day 21. Efficacy will be primarily evaluated by percentage of participants with eradication of helminthic and/or protozoa. Participants' safety will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mebendazole + Quinfamide | Experimental | Drug: Mebendazole, Drug: QuinfamideParticipants will receive mebendazole 600 milligram (mg) and quinfamide 200 mg tablets orally once starting on Day 1 and 21 in both Phase 1 and 2. |
| Mebendazole + Quinfamide + Placebo | Experimental | Drug: Mebendazole, Drug: Quinfamide, Drug: PlaceboParticipants will receive mebendazole 600 mg and quinfamide 200 mg tablets orally once starting on Day 1 in Phase 1 and placebo tablets orally once starting on Day 21 in Phase 2. |
Who may qualify
- Ages
- 10 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Minors whose parents or tutor grant his/her informed consent in writing to participate in the study. Adult participants that give their informed consent in writing to participate
- Participants having a copro-parasitoscopy test (scatology) (at least 1 with a series of 3) qualitative and quantitative and/or search of live amoeba, that comes out positive for one or more of the following parasites: Ascaris lumbricoides, Enterobius vermicularis, Trichuris trichuria, Taenia solium, Necator americanus, Ancylostoma duodenale and Trophozoites of Entamoeba histolytica
- With at least two or more of the following symptoms: Anorexia, Nausea, Vomit, Abdominal pain, Diarrhea, Constipation, Evacuations with mucus, Evacuations with blood, Gas discharge, Weight loss and Bruxism
Key exclusion criteria (7 listed)
- Participants with any known allergy to any of the drugs used in the investigation
- Female Participant in reproductive age not using an adequate contraceptive method
- Pregnant or lactating Participant
- Participant with any life-threatening condition (cancer, AIDS, etc.)
- Participant known to be a carrier of some illness that alters the metabolism or drug excretion (hepatic or renal illness) interfering with the absorption (malabsorption) or interferes with the evaluation of the Participant during 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 |
|---|---|---|
| MebendazoleMebendazole 600 milligram (mg) tablet orally once starting on Day 1 and 21. | Drug | Mebendazole + Quinfamide, Mebendazole + Quinfamide + Placebo |
| QuinfamideQuinfamide 200 mg tablet orally once starting on Day 1 and 21. | Drug | Mebendazole + Quinfamide, Mebendazole + Quinfamide + Placebo |
| PlaceboPlacebo tablet orally once starting on Day 21. | Drug | Mebendazole + Quinfamide + Placebo |
Primary outcome
Percentage of Participants with Eradication of Helminthic and/or Protozoa (Trophozoites of Amoeba)
Time frame: Day 21
Participants must show the results of a negative copro-parasitoscopy exam and fresh amoeba test after the first and second treatment phase. Those participants presenting a positive result during the control exams will be considered as "Therapeutic failure".
Percentage of Participants with Eradication of Helminthic and/or Protozoa (Trophozoites of Amoeba)
Time frame: Day 43
Participants must show the results of a negative copro-parasitoscopy exam and fresh amoeba test after the first and second treatment phase. Those participants presenting a positive result during the control exams will be considered as "Therapeutic failure".
3 secondary outcomes
Percentage of Participants with Abdominal Symptoms Relieve
Time frame: Day 43
Percentage of Participants with Improved Quality of Life
Time frame: Day 43
Number of Participants with Adverse Events (AEs) and Serious AEs
Time frame: Screening up to follow-up (Day 43)
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 14 Apr 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.
Janssen-Cilag Ltd Clinical Trial study director
Janssen-Cilag Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mebendazole and Quinfamide in people with Helminthiasis and Amoebiasis, run by Janssen-Cilag Ltd. at 1 site in Mexico.
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 7 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 14 Apr 2015. 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 Mexico. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Percentage of Participants with Eradication of Helminthic and/or Protozoa (Trophozoites of Amoeba) (time frame: Day 21). The study lists 2 primary outcomes in all. 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 14 Apr 2015.