Lubiprostone Effects on Visceral Pain Sensitivity

This study has been completed.
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
William Whitehead, PhD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01166789
First received: July 19, 2010
Last updated: September 14, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Irritable Bowel Syndrome
Drug: Lubiprostone
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Lubiprostone Effects on Visceral Pain Sensitivity

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Pain threshold [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: February 2008
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lubiprostone
Lubiprostone 48ug taken daily for 14 days.
Drug: Lubiprostone
48ug daily taken as 24ug capsules twice per day, in morning and evening.
Other Name: Amitiza
Placebo Comparator: Placebo
2 capsules containing a substance with no active ingredient taken daily for 14 days.
Drug: Placebo
2 capsules daily, taken in morning and evening

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01166789

Locations
United States, North Carolina
UNC Clinical and Translational Research Center
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Takeda
Investigators
Principal Investigator: William E Whitehead, PhD University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: William Whitehead, PhD, Professor of Medicine, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01166789     History of Changes
Other Study ID Numbers: 07-004L
Study First Received: July 19, 2010
Last Updated: September 14, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
IBS
pain threshold
constipation

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 29, 2014