Lubiprostone Effects on Visceral Pain Sensitivity

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.

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Drug: Lubiprostone; Drug: Placebo

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: Interventional
• Enrollment (Actual): 62
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC Clinical and Translational Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pain threshold	2 weeks

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Takeda

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (ACTUAL): August 1, 2010
• Study Completion (ACTUAL): August 1, 2010

Study Registration Dates

• First Submitted: July 19, 2010
• First Submitted That Met QC Criteria: July 19, 2010
• First Posted (ESTIMATE): July 21, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): September 16, 2011
• Last Update Submitted That Met QC Criteria: September 14, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: IBS; pain threshold; constipation
• Additional Relevant MeSH Terms: Digestive System Diseases; Pain; Neurologic Manifestations; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Nociceptive Pain; Irritable Bowel Syndrome; Visceral Pain; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Chloride Channel Agonists; Lubiprostone
• Other Study ID Numbers: 07-004L