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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

Tracking Information
First Submitted Date  ICMJE July 19, 2010
First Posted Date  ICMJE October 26, 2011
Results First Submitted Date  ICMJE April 3, 2018
Results First Posted Date  ICMJE July 13, 2018
Last Update Posted Date July 13, 2018
Study Start Date  ICMJE September 2007
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2018)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: October 25, 2011)
evaluation of gastric emptying [ Time Frame: 1 week ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Lubiprostone on Gastric Function in Patients With Chronic Idiopathic Constipation
Official Title  ICMJE Effects of Lubiprostone on Gastric Sensory and Motor Function in Patients With Chronic Idiopathic Constipation
Brief Summary This prospective study is designed to evaluate how lubiprostone may affect gastric motor and sensory function.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Chronic Idiopathic Constipation
Intervention  ICMJE Drug: lubiprostone
24 micrograms twice daily for 1 week
Study Arms  ICMJE Experimental: Treatment
24 micrograms of lubiprostone twice daily for one week.
Intervention: Drug: lubiprostone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 24, 2012)
19
Original Estimated Enrollment  ICMJE
 (submitted: October 25, 2011)
24
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • chronic idiopathic constipation

Exclusion Criteria:

  • medications that slow gastrointestinal (GI) motility
  • prior surgery to the GI tract
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01460225
Other Study ID Numbers  ICMJE 07-033L
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dartmouth-Hitchcock Medical Center
Study Sponsor  ICMJE Dartmouth-Hitchcock Medical Center
Collaborators  ICMJE Takeda Pharmaceuticals North America, Inc.
Investigators  ICMJE Not Provided
PRS Account Dartmouth-Hitchcock Medical Center
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP