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

April 13, 2015 updated by: Janssen-Cilag Ltd.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 71 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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".
Day 21
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".
Day 43

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants with Abdominal Symptoms Relieve
Time Frame: Day 43
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
Time Frame: Day 43
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
Time Frame: Screening up to follow-up (Day 43)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen-Cilag Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

January 1, 2006

Study Completion (Actual)

January 1, 2006

Study Registration Dates

First Submitted

March 5, 2015

First Submitted That Met QC Criteria

March 5, 2015

First Posted (Estimate)

March 11, 2015

Study Record Updates

Last Update Posted (Estimate)

April 14, 2015

Last Update Submitted That Met QC Criteria

April 13, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR003685
  • JC/AMO/REC/0605 (Other Identifier: Janssen-Cilag Ltd)
  • MEBENDAZOLGAI3001 (Other Identifier: Janssen-Cilag Ltd)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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