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Lubiprostone Effects on Visceral Pain Sensitivity

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lubiprostone
Placebo
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring IBS, pain threshold, constipation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UNC Clinical and Translational Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Lubiprostone

Placebo

Arm Description

Lubiprostone 48ug taken daily for 14 days.

2 capsules containing a substance with no active ingredient taken daily for 14 days.

Outcomes

Primary Outcome Measures

Pain threshold

Secondary Outcome Measures

Full Information

First Posted
July 19, 2010
Last Updated
September 14, 2011
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT01166789
Brief Title
Lubiprostone Effects on Visceral Pain Sensitivity
Official Title
Lubiprostone Effects on Visceral Pain Sensitivity
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Takeda

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
IBS, pain threshold, constipation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lubiprostone
Arm Type
Active Comparator
Arm Description
Lubiprostone 48ug taken daily for 14 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
2 capsules containing a substance with no active ingredient taken daily for 14 days.
Intervention Type
Drug
Intervention Name(s)
Lubiprostone
Other Intervention Name(s)
Amitiza
Intervention Description
48ug daily taken as 24ug capsules twice per day, in morning and evening.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
2 capsules daily, taken in morning and evening
Primary Outcome Measure Information:
Title
Pain threshold
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William E Whitehead, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNC Clinical and Translational Research Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

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Lubiprostone Effects on Visceral Pain Sensitivity

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