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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2006-01-31

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.

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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.

Conditions

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Helminthiasis Amoebiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Mebendazole + Quinfamide

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.

Group Type EXPERIMENTAL

Mebendazole

Intervention Type DRUG

Mebendazole 600 milligram (mg) tablet orally once starting on Day 1 and 21.

Quinfamide

Intervention Type DRUG

Quinfamide 200 mg tablet orally once starting on Day 1 and 21.

Mebendazole + Quinfamide + Placebo

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.

Group Type EXPERIMENTAL

Mebendazole

Intervention Type DRUG

Mebendazole 600 milligram (mg) tablet orally once starting on Day 1 and 21.

Quinfamide

Intervention Type DRUG

Quinfamide 200 mg tablet orally once starting on Day 1 and 21.

Placebo

Intervention Type DRUG

Placebo tablet orally once starting on Day 21.

Interventions

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Mebendazole

Mebendazole 600 milligram (mg) tablet orally once starting on Day 1 and 21.

Intervention Type DRUG

Quinfamide

Quinfamide 200 mg tablet orally once starting on Day 1 and 21.

Intervention Type DRUG

Placebo

Placebo tablet orally once starting on Day 21.

Intervention Type DRUG

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

Minimum Eligible Age

10 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No