Back to resultsStudy 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
Primary Purpose
Helminthiasis, Amoebiasis
Status
Completed
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
Mebendazole
Quinfamide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Helminthiasis focused on measuring Helminthiasis, Amoebiasis, Mebendazole, Quinfamide, Mexican population
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Mebendazole + Quinfamide
Mebendazole + Quinfamide + Placebo
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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".
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".
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02385058
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
January 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen-Cilag Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helminthiasis, Amoebiasis
Keywords
Helminthiasis, Amoebiasis, Mebendazole, Quinfamide, Mexican population
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mebendazole + Quinfamide
Arm Type
Experimental
Arm Description
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.
Arm Title
Mebendazole + Quinfamide + Placebo
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Mebendazole
Intervention Description
Mebendazole 600 milligram (mg) tablet orally once starting on Day 1 and 21.
Intervention Type
Drug
Intervention Name(s)
Quinfamide
Intervention Description
Quinfamide 200 mg tablet orally once starting on Day 1 and 21.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet orally once starting on Day 21.
Primary Outcome Measure Information:
Title
Percentage of Participants with Eradication of Helminthic and/or Protozoa (Trophozoites of Amoeba)
Description
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".
Time Frame
Day 21
Title
Percentage of Participants with Eradication of Helminthic and/or Protozoa (Trophozoites of Amoeba)
Description
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".
Time Frame
Day 43
Secondary Outcome Measure Information:
Title
Percentage of Participants with Abdominal Symptoms Relieve
Description
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.
Time Frame
Day 43
Title
Percentage of Participants with Improved Quality of Life
Description
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.
Time Frame
Day 43
Title
Number of Participants with Adverse Events (AEs) and Serious AEs
Description
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.
Time Frame
Screening up to follow-up (Day 43)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen-Cilag Ltd Clinical Trial
Organizational Affiliation
Janssen-Cilag Ltd.
Official's Role
Study Director
Facility Information:
City
Mex
Country
Mexico
12. IPD Sharing Statement
Learn more about this trial
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
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