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

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.
 
ClinicalTrials.gov Identifier: NCT01460225
Recruitment Status : Completed
First Posted : October 26, 2011
Results First Posted : July 13, 2018
Last Update Posted : July 13, 2018
Sponsor:
Collaborator:
Takeda Pharmaceuticals North America, Inc.
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

Study Description
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Brief Summary:
This prospective study is designed to evaluate how lubiprostone may affect gastric motor and sensory function.

Condition or disease Intervention/treatment Phase
Chronic Idiopathic Constipation Drug: lubiprostone Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: N/A
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
Study Start Date : September 2007
Actual Primary Completion Date : December 2010
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment
24 micrograms of lubiprostone twice daily for one week.
 Drug: lubiprostone
24 micrograms twice daily for 1 week


Outcome Measures
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Primary Outcome Measures :
  1. Gastric Emptying [ Time Frame: Day 1 and Day 7 ]
    gastric emptying was measured before and after 7 days of treatment.at set times (2 and 4 hours post eating a radio-labeled meal)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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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
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01460225    
Other Study ID Numbers: 07-033L
First Posted: October 26, 2011    Key Record Dates
Results First Posted: July 13, 2018
Last Update Posted: July 13, 2018
Last Verified: July 2018
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:
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Constipation
Signs and Symptoms, Digestive
Lubiprostone
 Chloride Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action