Effects of Lubiprostone on Gastric Function in Patients With Chronic Idiopathic Constipation

This study has been completed.
Sponsor:
Collaborator:
Takeda Pharmaceuticals North America, Inc.
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT01460225
First received: July 19, 2010
Last updated: February 24, 2012
Last verified: February 2012
  Purpose

This prospective study is designed to evaluate how lubiprostone may affect gastric motor and sensory function.


Condition Intervention Phase
Chronic Idiopathic Constipation
Drug: lubiprostone
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Effects of Lubiprostone on Gastric Sensory and Motor Function in Patients With Chronic Idiopathic Constipation

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • evaluation of gastric emptying [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: September 2007
Study Completion Date: January 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: lubiprostone
    24 micrograms twice daily for 1 week
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • chronic idiopathic constipation

Exclusion Criteria:

  • medications that slow gastrointestinal (GI) motility
  • prior surgery to the GI tract
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01460225

Locations
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Takeda Pharmaceuticals North America, Inc.
  More Information

No publications provided

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01460225     History of Changes
Other Study ID Numbers: 07-033L
Study First Received: July 19, 2010
Last Updated: February 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Dartmouth-Hitchcock Medical Center:
constipation
chronic idiopathic constipation
no prior history of surgery to the colon
not on any type of medication that could alter gastrointestinal motility or transit

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

ClinicalTrials.gov processed this record on October 23, 2014