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Lubiprostone Effects on Visceral Pain Sensitivity

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ClinicalTrials.gov Identifier: NCT01166789
Recruitment Status : Completed
First Posted : July 21, 2010
Last Update Posted : September 16, 2011
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
William Whitehead, PhD, University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date  ICMJE July 19, 2010
First Posted Date  ICMJE July 21, 2010
Last Update Posted Date September 16, 2011
Study Start Date  ICMJE February 2008
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2010)
Pain threshold [ Time Frame: 2 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
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 Lubiprostone Effects on Visceral Pain Sensitivity
Official Title  ICMJE Lubiprostone Effects on Visceral Pain Sensitivity
Brief Summary The purpose of this research study is to determine how Lubiprostone, a medication used to treat irritable bowel syndrome with constipation predominant symptoms (IBS-C), works to reduce clinical pain. Lubiprostone acts in the small intestine to cause an increase in the secretion of chloride, water and sodium. The increased fluid causes food residue to move through the bowel more quickly and makes the stools softer. First, we want to test the idea that Lubiprostone works by making a person less sensitive to pain. Second, we want to confirm that Lubiprostone decreases the time it takes fecal matter to travel through your GI tract, referred to as transit time.
Detailed Description Subjects will be enrolled in an 8-week study requiring a total of 7 visits to the UNC Center for Clinical and Translational Research. The protocol is divided into 4 two-week periods: (1) Two-week baseline diary symptom monitoring, followed by a barostat test of pain sensitivity. (2) Two-week treatment with either Lubiprostone or placebo, with daily symptom diary recording and barostat test of pain sensitivity at the end. In addition, patients will be tested for whole gut transit time by the radio-opaque marker (Sitzmark) technique in the second week. (3) Two-week washout period, during which patients will continue the symptom diary. (4) Two-week crossover to Lubiprostone or placebo, identical to the second two-week period.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Irritable Bowel Syndrome
Intervention  ICMJE
  • Drug: Lubiprostone
    48ug daily taken as 24ug capsules twice per day, in morning and evening.
    Other Name: Amitiza
  • Drug: Placebo
    2 capsules daily, taken in morning and evening
Study Arms  ICMJE
  • Active Comparator: Lubiprostone
    Lubiprostone 48ug taken daily for 14 days.
    Intervention: Drug: Lubiprostone
  • Placebo Comparator: Placebo
    2 capsules containing a substance with no active ingredient taken daily for 14 days.
    Intervention: Drug: Placebo
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: July 19, 2010)
62
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • clinical diagnosis of IBS-C
  • meeting Rome III diagnostic criteria for IBS-C
  • age 18 or older

Exclusion Criteria:

  • use of laxatives or prokinetics within two weeks prior to the study or during the study
  • use of IBS-specific compounds, opiates, anticholinergics, or any drug likely to cause constipation as a side-effect
  • use of analgesics for 48 hours prior to the study
  • hypothyroid condition
  • history of bowel resection except appendectomy or cholecystectomy
  • psychotic disorder, major depression, substance abuse (other than tobacco), or other psychiatric condition likely to interfere with the conduct of the study. Subjects treated for depression more than 2 years ago or for situational circumstances may be eligible for the study at the investigator's discretion
  • renal disease
  • inflammatory or ischemic disease of the rectum
  • known to be an unreliable subject
  • Because this study involves exposure to radiation, subjects who are pregnant or planning to become pregnant, employees currently working with radiation, and subjects who have participated in research involving radiation within the past year will also be excluded.
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 NCT01166789
Other Study ID Numbers  ICMJE 07-004L
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party William Whitehead, PhD, University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE Takeda
Investigators  ICMJE
Principal Investigator: William E Whitehead, PhD University of North Carolina, Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date September 2011

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