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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
History of Changes
  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:

MedlinePlus related topics: Constipation
U.S. FDA Resources

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
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, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013