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Completed

NCT Number: NCT02281630

Phase II Dose-Finding Study of KWA-0711 in Patients With Chronic Constipation (CC)

The purpose of this study is to evaluate the efficacy and safety of KWA-0711, and to determine its optimal dose in Chronic Constipation (CC) patients.

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Key information

Conditions

Chronic Constipation

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tokyo and Other Japanese City, Japan

Who can participate

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

Inclusion criteria

  • The patients who experienced fewer than three SBMs 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

Placebo

Drug

Primary outcomes

  1. Change from baseline in the weekly number of Spontaneous Bowel Movements (SBMs) at Week 1

    Time frame: 1 week

Secondary outcomes

  1. Complete SBM (CSBM) frequency and responder rate

    Time frame: 4 weeks

  2. SBM frequency and responder rate

    Time frame: 4 weeks

  3. Time to first SBM after the initial dose

    Time frame: 4 weeks

  4. Stool consistency

    Time frame: 4 weeks

  5. Degree of straining

    Time frame: 4 weeks

  6. Abdominal bloating and discomfort

    Time frame: 4 weeks

  7. Use of rescue medications

    Time frame: 4 weeks

  8. Global assessment of constipation severity

    Time frame: 4 weeks

  9. Japanese version of IBS-QOL

    Time frame: 4 weeks

  10. Global assessment of treatment effectiveness

    Time frame: 4 weeks

  11. Satisfaction rating for the condition of bowel movements

    Time frame: 4 weeks

  12. Adverse events, ECGs, vital signs, and clinical labs

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Kissei Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

Phase II, Randomized, Placebo-controlled, Double-blind, Parallel-group Study of KWA-0711 Administered Orally for 4 Weeks to Evaluate Its Efficacy and Safety, and to Determine Its Optimal Dose in Patients With Chronic Constipation (CC)

Important dates

Study start
2014
Primary completion
2015
First posted
Nov 3, 2014
Registry last updated
May 22, 2017

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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