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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01600001
First received: May 14, 2012
Last updated: October 29, 2013
Last verified: October 2013
  Purpose

The purpose of this study is to evaluate the efficacy and safety of KWA-0711 in Chronic Idiopathic Constipation (CIC) patients.


Condition Intervention Phase
Chronic Idiopathic Constipation
Drug: KWA-0711
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Phase II Study of KWA-0711 in Patients With Chronic Idiopathic Constipation (CIC)

Resource links provided by NLM:


Further study details as provided by Kissei Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Improvement of signs and symptoms associated with constipation [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Arms Assigned Interventions
Experimental: Drug:KWA-0711 dose 1 Drug: KWA-0711
Experimental: Drug:KWA-0711 dose 2 Drug: KWA-0711
Experimental: Drug:KWA-0711 dose 3 Drug: KWA-0711
Experimental: Drug:KWA-0711 dose 4 Drug: KWA-0711
Placebo Comparator: Drug: Placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01600001

Locations
Japan
Japan
Tokyo and Other Japanese City, Japan
Sponsors and Collaborators
Kissei Pharmaceutical Co., Ltd.
  More Information

No publications provided

Responsible Party: Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01600001     History of Changes
Other Study ID Numbers: KWA1201
Study First Received: May 14, 2012
Last Updated: October 29, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kissei Pharmaceutical Co., Ltd.:
Chronic Idiopathic Constipation (CIC)
Constipation
Functional gastrointestinal disorders

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014