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CompletedNCT02343978Updated May 22, 2017

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

A Phase 2 interventional study of KWA-0711 in Chronic Constipation, sponsored by Kissei Pharmaceutical Co., Ltd.. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2017-05-22.

Sponsored by Kissei Pharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
37
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Chronic Constipation

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Keywords

  • Chronic Constipation
  • CC
03

In context

Constipation

1,018 studies on the registry are indexed under Constipation; 139 are open to participants now.

This study's enrollment of 37 is below the median of 80 across 850 interventional studies indexed under Constipation.

Browse Constipation studies →

Lead sponsor

Kissei Pharmaceutical Co., Ltd. is the lead sponsor of 61 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All

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

Exclusion Criteria:

  • Patients who have secondary constipation caused by systemic disorder
  • Patients who have organic constipation
  • Patients who received intestinal resection
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
37 participants (actual)

Study arms

  • Experimental
    KWA-0711 High dose

    Drug: KWA-0711

  • Experimental
    KWA-0711 Low dose

    Drug: KWA-0711

Interventions

  • DrugKWA-0711
06

What researchers measure

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

07

Study locations

1 site
  • Tokyo, Japan
08

References and documents

Publications

  • Fukudo S, Endo Y, Hongo M, Nakajima A, Abe T, Kobayashi H, Nakata T, Nakajima T, Sameshima K, Kaku K; Mizagliflozin Study Group. Safety and efficacy of the sodium-glucose cotransporter 1 inhibitor mizagliflozin for functional constipation: a randomised, placebo-controlled, double-blind phase 2 trial. Lancet Gastroenterol Hepatol. 2018 Sep;3(9):603-613. doi: 10.1016/S2468-1253(18)30165-1. Epub 2018 Jul 25. Erratum In: Lancet Gastroenterol Hepatol. 2018 Sep;3(9):e4. doi: 10.1016/S2468-1253(18)30245-0. PubMed 30056028 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02343978
Lead sponsor
Kissei Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Jan 22, 2015
Start date
Dec 26, 2014
Primary completion
May 1, 2015
Last update
May 22, 2017

Study contacts

Tatsuro Takei
study director · Kissei Pharmaceutical Co., Ltd.
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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