ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02385058
Recruitment Status : Completed
First Posted : March 11, 2015
Last Update Posted : April 14, 2015
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag Ltd.

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.

Condition or disease Intervention/treatment Phase
Helminthiasis Amoebiasis Drug: Mebendazole Drug: Quinfamide Drug: Placebo Phase 4

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  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : October 2005
Actual Primary Completion Date : January 2006
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Mebendazole

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.




Primary Outcome Measures :
  1. 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".

  2. 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".


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   10 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02385058


Locations
Mexico
Mex, Mexico
Sponsors and Collaborators
Janssen-Cilag Ltd.
Investigators
Study Director: Janssen-Cilag Ltd Clinical Trial Janssen-Cilag Ltd.

Responsible Party: Janssen-Cilag Ltd.
ClinicalTrials.gov Identifier: NCT02385058     History of Changes
Other Study ID Numbers: CR003685
JC/AMO/REC/0605 ( Other Identifier: Janssen-Cilag Ltd )
MEBENDAZOLGAI3001 ( Other Identifier: Janssen-Cilag Ltd )
First Posted: March 11, 2015    Key Record Dates
Last Update Posted: April 14, 2015
Last Verified: April 2015

Keywords provided by Janssen-Cilag Ltd.:
Helminthiasis
Amoebiasis
Mebendazole
Quinfamide
Mexican population

Additional relevant MeSH terms:
Piperazine
Piperazine citrate
Helminthiasis
Amebiasis
Dysentery, Amebic
Parasitic Diseases
Protozoan Infections
Intestinal Diseases, Parasitic
Dysentery
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Mebendazole
Antinematodal Agents
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents