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Completed

NCT Number: NCT00067561

Study Of Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome Having Failed Conventional Therapy

The purpose of this study is to compare the safety and effectiveness of different doses of an investigational medication in women with severe diarrhea-predominant Irritable Bowel Syndrome (IBS) who have failed conventional therapy.

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Key information

Conditions

Irritable Colon Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome Irritable Bowel Syndrome (IBS)

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Nedlands, Western Australia, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosed with severe diarrhea-predominant Irritable Bowel Syndrome (IBS).
  • Failed conventional therapy.
  • Willing to make daily calls on a touch-tone telephone.

Exclusion criteria

  • History of or current chronic or severe constipation.
  • Bloody diarrhea, abdominal pain with rectal bleeding.
  • Thrombophlebitis.
  • Abnormal thyroid stimulating hormone (TSH) value.
  • Alcohol and/or substance abuse within past two years.
  • Pregnant or lactating.
  • History/treatment of malignancy within past five years.

Treatment and study plan

Alosetron

Drug

Primary outcomes

  1. Subject self assessment of improvement between treatment groups using the IBS Global Improvement Scale; comparison of safety and tolerability between treatment groups with respect to adverse events & laboratory abnormalities.

Secondary outcomes

  1. Comparison of treatment groups with respect to subject relief of IBS pain & discomfort.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Twelve-Week, Randomized, Double Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of 0.5 mg QD, 1 mg QD and 1 mg BID of Alosetron in Female Subjects With Severe Diarrhea-predominant IBS Who Have Failed Conventional Therapy

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Aug 25, 2003
Registry last updated
Apr 16, 2015

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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