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

Helminthiasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02385058
• Other study ID #: CR003685
• Secondary ID: JC/AMO/REC/0605M
• Status: Completed
• Phase: Phase 4
• First received: March 5, 2015
• Last updated: April 13, 2015
• Start date: October 2005
• Est. completion date: January 2006

Study information

• Verified date: April 2015
• Source: Janssen-Cilag Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Protection Against Health Risks
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amebiasis
• Amoebiasis
• Helminthiasis
• Intestinal Diseases

Intervention

Drug:
• Mebendazole
Mebendazole 600 milligram (mg) tablet orally once starting on Day 1 and 21.
• Quinfamide
Quinfamide 200 mg tablet orally once starting on Day 1 and 21.
• Placebo
Placebo tablet orally once starting on Day 21.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen-Cilag Ltd.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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)	Yes