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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01460225
First Posted: October 26, 2011
Last Update Posted: February 27, 2012
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.
Collaborator:
Takeda Pharmaceuticals North America, Inc.
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
  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: None (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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): 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

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01460225     History of Changes
Other Study ID Numbers: 07-033L
First Submitted: July 19, 2010
First Posted: October 26, 2011
Last Update Posted: February 27, 2012
Last Verified: February 2012

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
Lubiprostone
Chloride Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action