Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

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

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. Identifier: NCT02281630
Recruitment Status : Completed
First Posted : November 2, 2014
Last Update Posted : May 22, 2017
Information provided by (Responsible Party):
Kissei Pharmaceutical Co., Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Constipation Drug: KWA-0711 Drug: Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 388 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : October 15, 2014
Actual Primary Completion Date : April 28, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
Experimental: KWA-0711 High dose Drug: KWA-0711
Experimental: KWA-0711 Low dose Drug: KWA-0711
Placebo Comparator: Placebo Drug: Placebo

Primary Outcome Measures :
  1. Change from baseline in the weekly number of Spontaneous Bowel Movements (SBMs) at Week 1 [ Time Frame: 1 week ]

Secondary Outcome Measures :
  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 ]

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.

Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All

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.

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 identifier (NCT number): NCT02281630

Layout table for location information
Tokyo and Other Japanese City, Japan
Sponsors and Collaborators
Kissei Pharmaceutical Co., Ltd.
Layout table for investigator information
Study Director: Tatsuro Takei Kissei Pharmaceutical Co., Ltd.
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Kissei Pharmaceutical Co., Ltd. Identifier: NCT02281630    
Other Study ID Numbers: KWA1204
First Posted: November 2, 2014    Key Record Dates
Last Update Posted: May 22, 2017
Last Verified: May 2017
Keywords provided by Kissei Pharmaceutical Co., Ltd.:
Chronic Constipation
Additional relevant MeSH terms:
Layout table for MeSH terms
Signs and Symptoms, Digestive