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Trial record 2 of 194 for:    chronic constipation

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.
 
ClinicalTrials.gov Identifier: NCT02281630
Recruitment Status : Completed
First Posted : November 3, 2014
Last Update Posted : May 22, 2017
Sponsor:
Information provided by (Responsible Party):
Kissei Pharmaceutical Co., Ltd.

Tracking Information
First Submitted Date  ICMJE October 22, 2014
First Posted Date  ICMJE November 3, 2014
Last Update Posted Date May 22, 2017
Actual Study Start Date  ICMJE October 15, 2014
Actual Primary Completion Date April 28, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2014)
Change from baseline in the weekly number of Spontaneous Bowel Movements (SBMs) at Week 1 [ Time Frame: 1 week ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 30, 2014)
Change from baseline in the weekly number of Spontaneous Bowel Movements (SBMs) at Week 1 [ Time Frame: 4 weeks ]
Change History Complete list of historical versions of study NCT02281630 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2017)
  • Complete SBM (CSBM) frequency and responder rate [ Time Frame: 4 weeks ]
  • SBM frequency and responder rate [ Time Frame: 4 weeks ]
  • Time to first SBM after the initial dose [ Time Frame: 4 weeks ]
  • Stool consistency [ Time Frame: 4 weeks ]
  • Degree of straining [ Time Frame: 4 weeks ]
  • Abdominal bloating and discomfort [ Time Frame: 4 weeks ]
  • Use of rescue medications [ Time Frame: 4 weeks ]
  • Global assessment of constipation severity [ Time Frame: 4 weeks ]
  • Japanese version of IBS-QOL [ Time Frame: 4 weeks ]
  • Global assessment of treatment effectiveness [ Time Frame: 4 weeks ]
  • Satisfaction rating for the condition of bowel movements [ Time Frame: 4 weeks ]
  • Adverse events, ECGs, vital signs, and clinical labs [ Time Frame: 4 weeks ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase II Dose-Finding Study of KWA-0711 in Patients With Chronic Constipation (CC)
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Constipation
Intervention  ICMJE
  • Drug: KWA-0711
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: KWA-0711 High dose
    Intervention: Drug: KWA-0711
  • Experimental: KWA-0711 Low dose
    Intervention: Drug: KWA-0711
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Fukudo S, Endo Y, Hongo M, Nakajima A, Abe T, Kobayashi H, Nakata T, Nakajima T, Sameshima K, Kaku K; Mizagliflozin Study Group. Safety and efficacy of the sodium-glucose cotransporter 1 inhibitor mizagliflozin for functional constipation: a randomised, placebo-controlled, double-blind phase 2 trial. Lancet Gastroenterol Hepatol. 2018 Sep;3(9):603-613. doi: 10.1016/S2468-1253(18)30165-1. Epub 2018 Jul 25. Erratum in: Lancet Gastroenterol Hepatol. 2018 Sep;3(9):e4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 10, 2017)
388
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date April 28, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02281630
Other Study ID Numbers  ICMJE KWA1204
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kissei Pharmaceutical Co., Ltd.
Study Sponsor  ICMJE Kissei Pharmaceutical Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Tatsuro Takei Kissei Pharmaceutical Co., Ltd.
PRS Account Kissei Pharmaceutical Co., Ltd.
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP