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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
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, see Learn About Clinical Studies.

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
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on November 25, 2014