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Completed

NCT Number: NCT00685607

Study to Determine the Best Way to Measure How Quickly the Drug Can Give Relief From Sudden Diarrhea

For six hours following drug administration, subjects will rate the severity of specific symptoms. At the end of the six hour study, subjects will rate the overall effectiveness of the product.

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Key information

Conditions

Diarrhea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Universidad Autonoma de Guadalajara

Guadalajara, Jalisco, 44100, Mexico

About this study

A six-hour study to evaluate multiple early efficacy endpoints in loperamide-simethicone therapy to help identify speed of onset of symptomatic treatment of acute nonspecific diarrhea (ANSD).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of acute diarrhea with gas-related abdominal discomfort, meeting specific criteria
  • Willing to follow the protocol requirements and comply with protocol restrictions, including use of contraception
  • Able to understand the informed consent process and sign the form
  • Cooperative, reliable and willing to comply with the protocol requirements and schedule, and able to record efficacy and safety assessments.

Exclusion criteria

  • Female subjects who are pregnant, lactating or experiencing perimenstrual abdominal or pelvic discomfort
  • Illness requires hospitalization, IV fluids or antibiotics
  • Has taken antibiotics in the past 7 days or a symptomatic antidiarrheal compound in the past 12 hours or any analgesic in the past 6 hours
  • History of significant underlying enteric, pulmonary, hepatic, cardiac, renal disease, seizure disorder, IBD, cancer, uncontrolled diabetes, or any other unstable medical condition
  • History of hypersensitivity to loperamide or simethicone
  • Has previously participated in this study or received an investigational drug within the 30 day period before screening

Treatment and study plan

loperamide-simethicone

Drug

Four caplets containing 2 mg loperamide HCl and 125 mg of simethicone each, administered orally with 4-8 oz. of water according to the labeled directions of the currently marketed product (i.e., 2 caplets after first loose stool, followed by 1 caplet after each subsequent loose stool, not to exceed 4 caplets in 24 hours). The treatment period will last six hours.

Other names: Imodium

Matching Placebo

Drug

Four placebo caplets matching the caplets in Arm 1, administered orally with 4-8 oz. of water according to the labeled directions of the currently marketed product (i.e., 2 caplets after first loose stool, followed by 1 caplet after each subsequent loose stool, not to exceed 4 caplets in 24 hours). The treatment period will last six hours.

Other names: Placebo

Primary outcomes

  1. Evaluate Multiple Endpoints

    Time frame: 6 hours

Secondary outcomes

  1. Time to improvement in stool form

    Time frame: 6 hours

  2. Time to improvement in urge to defecate

    Time frame: 6 hours

  3. Time to improvement in gas-related abdominal discomfort

    Time frame: 6 hours

  4. Time to improvement of change in normal activities of daily living

    Time frame: 6 hours

  5. Subject global impression of efficacy of study medication at the end of the treatment period

    Time frame: 6 hours

  6. Physical examination and vital signs at the screening visit and the monitoring of adverse events throughout the course of the study

    Time frame: 6 hours

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Consumer and Personal Products Worldwide

Industry

Registry information

Official study title

A Placebo-Controlled, Double-Blind, Randomized Pilot Study to Evaluate the Appropriateness of Multiple Endpoints in Measuring the Onset of Clinical Efficacy of Loperamide-Simethicone Caplets in the Treatment of Acute Non-specific Diarrhea

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
May 28, 2008
Registry last updated
Oct 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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