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A Exploratory Study of KWA-0711 in Patients With Chronic Idiopathic Constipation (CIC)

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: NCT01600001
Recruitment Status : Completed
First Posted : May 16, 2012
Last Update Posted : October 30, 2013
Sponsor:
Information provided by (Responsible Party):
Kissei Pharmaceutical Co., Ltd.

May 14, 2012
May 16, 2012
October 30, 2013
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Improvement of signs and symptoms associated with constipation [ Time Frame: 4 weeks ]
Same as current
Complete list of historical versions of study NCT01600001 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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A Exploratory Study of KWA-0711 in Patients With Chronic Idiopathic Constipation (CIC)
A Randomized, Double-blind, Placebo-controlled, Phase II Study of KWA-0711 in Patients With Chronic Idiopathic Constipation (CIC)
The purpose of this study is to evaluate the efficacy and safety of KWA-0711 in Chronic Idiopathic Constipation (CIC) patients.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Chronic Idiopathic Constipation
  • Drug: KWA-0711
  • Drug: Placebo
  • Experimental: Drug:KWA-0711 dose 1
    Intervention: Drug: KWA-0711
  • Experimental: Drug:KWA-0711 dose 2
    Intervention: Drug: KWA-0711
  • Experimental: Drug:KWA-0711 dose 3
    Intervention: Drug: KWA-0711
  • Experimental: Drug:KWA-0711 dose 4
    Intervention: Drug: KWA-0711
  • Placebo Comparator: Drug: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
Same as current
Not Provided
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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
Sexes Eligible for Study: All
20 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01600001
KWA1201
No
Not Provided
Not Provided
Kissei Pharmaceutical Co., Ltd.
Kissei Pharmaceutical Co., Ltd.
Not Provided
Not Provided
Kissei Pharmaceutical Co., Ltd.
October 2013

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