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Phase II Study of KWA-0711 in Patients With Chronic Constipation (CC)

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: NCT02343978
Recruitment Status : Completed
First Posted : January 22, 2015
Last Update Posted : May 22, 2017
Sponsor:
Information provided by (Responsible Party):
Kissei Pharmaceutical Co., Ltd.

Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of KWA-0711 in Chronic Constipation (CC) patients.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II, Randomized, Open-label Study of KWA-0711 Administrated Orally for 2 Weeks to Evaluate Its Safety and Efficacy in Patients With Chronic Constipation (CC)
Actual Study Start Date : December 26, 2014
Actual Primary Completion Date : May 1, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
Experimental: KWA-0711 High dose Drug: KWA-0711
Experimental: KWA-0711 Low dose Drug: KWA-0711



Primary Outcome Measures :
  1. Incidence of Adverse Events [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Change in fasting and postprandial blood glucose levels [ Time Frame: 2 weeks ]
  2. Change in fasting and postprandial insulin levels [ Time Frame: 2 weeks ]
  3. ECGs, vital signs, and clinical labs [ Time Frame: 2 weeks ]
  4. Improvement of signs and symptoms associated with constipation [ Time Frame: 2 weeks ]


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 (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

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): NCT02343978


Locations
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Japan
Tokyo, Japan
Sponsors and Collaborators
Kissei Pharmaceutical Co., Ltd.
Investigators
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Study Director: Tatsuro Takei Kissei Pharmaceutical Co., Ltd.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02343978     History of Changes
Other Study ID Numbers: KWA1205
First Posted: January 22, 2015    Key Record Dates
Last Update Posted: May 22, 2017
Last Verified: May 2017
Keywords provided by Kissei Pharmaceutical Co., Ltd.:
Chronic Constipation
CC
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive
Signs and Symptoms