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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Helminthiasis, Amoebiasis

Intervention / Treatment
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* Drug: Mebendazole
* Drug: Quinfamide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mebendazole + Quinfamide<br>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. | Drug: Mebendazole<br>* Mebendazole 600 milligram (mg) tablet orally once starting on Day 1 and 21.<br>Drug: Quinfamide<br>* Quinfamide 200 mg tablet orally once starting on Day 1 and 21.<br>|
| Experimental: Mebendazole + Quinfamide + Placebo<br>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. | Drug: Mebendazole<br>* Mebendazole 600 milligram (mg) tablet orally once starting on Day 1 and 21.<br>Drug: Quinfamide<br>* Quinfamide 200 mg tablet orally once starting on Day 1 and 21.<br>Drug: Placebo<br>* Placebo tablet orally once starting on Day 21.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Day 43 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Screening up to follow-up (Day 43) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amoebiasis, Mebendazole, Quinfamide, Mexican population, Helminthiasis