Back to resultsEffects of Lubiprostone on Gastric Function in Patients With Chronic Idiopathic Constipation
Primary Purpose
Chronic Idiopathic Constipation
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
lubiprostone
Sponsored by
About this trial
This is an interventional health services research trial for Chronic Idiopathic Constipation focused on measuring 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
Eligibility Criteria
Inclusion Criteria:
- chronic idiopathic constipation
Exclusion Criteria:
- medications that slow gastrointestinal (GI) motility
- prior surgery to the GI tract
Sites / Locations
- Dartmouth-Hitchcock Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
24 micrograms of lubiprostone twice daily for one week.
Outcomes
Primary Outcome Measures
Gastric Emptying
gastric emptying was measured before and after 7 days of treatment.at set times (2 and 4 hours post eating a radio-labeled meal)
Secondary Outcome Measures
Full Information
NCT ID
NCT01460225
First Posted
July 19, 2010
Last Updated
July 12, 2018
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Takeda Pharmaceuticals North America, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01460225
Brief Title
Effects of Lubiprostone on Gastric Function in Patients With Chronic Idiopathic Constipation
Official Title
Effects of Lubiprostone on Gastric Sensory and Motor Function in Patients With Chronic Idiopathic Constipation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Takeda Pharmaceuticals North America, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This prospective study is designed to evaluate how lubiprostone may affect gastric motor and sensory function.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Idiopathic Constipation
Keywords
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
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
24 micrograms of lubiprostone twice daily for one week.
Intervention Type
Drug
Intervention Name(s)
lubiprostone
Intervention Description
24 micrograms twice daily for 1 week
Primary Outcome Measure Information:
Title
Gastric Emptying
Description
gastric emptying was measured before and after 7 days of treatment.at set times (2 and 4 hours post eating a radio-labeled meal)
Time Frame
Day 1 and Day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
chronic idiopathic constipation
Exclusion Criteria:
medications that slow gastrointestinal (GI) motility
prior surgery to the GI tract
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effects of Lubiprostone on Gastric Function in Patients With Chronic Idiopathic Constipation
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