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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01600001
First Posted: May 16, 2012
Last Update Posted: October 30, 2013
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.
Information provided by (Responsible Party):
Kissei Pharmaceutical Co., Ltd.
  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
Intervention Model: Parallel Assignment
Masking: Double
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 ]

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

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.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT01600001


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

Responsible Party: Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01600001     History of Changes
Other Study ID Numbers: KWA1201
First Submitted: May 14, 2012
First Posted: May 16, 2012
Last Update Posted: October 30, 2013
Last Verified: October 2013

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