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OpenTrials
Completed

NCT Number: NCT01937663

A Single-blind, Dose-tapering Study of KWA-0711 in Patients With Chronic Constipation

The purpose of this study is to evaluate the efficacy and safety of tapered KWA-0711 dose in chronic constipation patients.

Completed

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Key information

Conditions

Chronic Constipation Constipation Digestive System Diseases Gastrointestinal Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tokyo, Japan

Who can participate

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

Inclusion criteria

  • The patients who experienced fewer than three spontaneous bowel movements per week for more than 6 months prior to the enrollment.
  • The patients who experienced one or more of the following signs or symptoms during more than 25% of bowel movements for more than 6 months: straining, lumpy or hard stools, and a sensation of incomplete evacuation

Exclusion criteria

  • Patients who have secondary constipation caused by systemic disorder.
  • Patients who have organic constipation.
  • Patients who received intestinal resection.

Treatment and study plan

KWA-0711

Drug

Primary outcomes

  1. Improvement of signs and symptoms associated with constipation

    Time frame: 4 weeks

    • Frequency of Spontaneous Bowel Movements
    • Bowel Movement Timing
    • Stool Consistency
    • Abdominal Assessment
    • QOL Assessment

Sponsors and collaborators

Lead sponsor

Kissei Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Primary completion
2014
First posted
Sep 9, 2013
Registry last updated
Nov 13, 2014

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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