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Completed

NCT Number: NCT02343978

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

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

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Key information

Conditions

Chronic Constipation

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tokyo, Japan

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KWA-0711

Drug

Primary outcomes

  1. Incidence of Adverse Events

    Time frame: 2 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Kissei Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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)

Important dates

Study start
2014
Primary completion
2015
First posted
Jan 22, 2015
Registry last updated
May 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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