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A Single-blind, Dose-titration Study of KWA-0711 in Patients With Chronic Constipation

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ClinicalTrials.gov Identifier: NCT01938196
Recruitment Status : Completed
First Posted : September 10, 2013
Last Update Posted : November 13, 2014
Sponsor:
Information provided by (Responsible Party):
Kissei Pharmaceutical Co., Ltd.

Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of titrated KWA-0711 dose in chronic constipation patients.

Condition or disease Intervention/treatment Phase
Chronic Constipation Drug: KWA-0711 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Primary Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
Experimental: KWA-0711 Dose1 Drug: KWA-0711
Experimental: KWA-0711 Dose2 Drug: KWA-0711
Experimental: KWA-0711 Dose3 Drug: KWA-0711
Experimental: KWA-0711 Dose4 Drug: KWA-0711
Placebo Comparator: Placebo Drug: Placebo



Primary Outcome Measures :
  1. Improvement of signs and symptoms associated with constipation [ Time Frame: 5 weeks ]
    • Frequency of Spontaneous Bowel Movements
    • Bowel Movement Timing
    • Stool Consistency
    • Abdominal Assessment
    • QOL Assessment



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • The patients who experienced fewer than three spontaneous bowel movements 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

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): NCT01938196


Locations
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Japan
Tokyo, Japan
Sponsors and Collaborators
Kissei Pharmaceutical Co., Ltd.

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Responsible Party: Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01938196     History of Changes
Other Study ID Numbers: KWA1202
First Posted: September 10, 2013    Key Record Dates
Last Update Posted: November 13, 2014
Last Verified: November 2014

Keywords provided by Kissei Pharmaceutical Co., Ltd.:
Chronic Constipation
Constipation
Functional gastrointestinal disorders

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