Lubiprostone Effects on Visceral Pain Sensitivity

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

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.

Condition or disease	Intervention/treatment	Phase
Irritable Bowel Syndrome	Drug: Lubiprostone; Drug: Placebo	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 62 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Lubiprostone Effects on Visceral Pain Sensitivity
• Study Start Date: February 2008
• Actual Primary Completion Date: August 2010
• Actual Study Completion Date: August 2010

Arms and Interventions

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 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

Outcome Measures

Primary Outcome Measures :

1. Pain threshold [ Time Frame: 2 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: William Whitehead, PhD, Professor of Medicine, University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT01166789
• Other Study ID Numbers: 07-004L
• First Posted: July 21, 2010
• Last Update Posted: September 16, 2011
• Last Verified: September 2011

Keywords provided by William Whitehead, PhD, University of North Carolina, Chapel Hill:

IBS; pain threshold; constipation

Additional relevant MeSH terms:

Irritable Bowel Syndrome; Visceral Pain; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Nociceptive Pain; Pain; Neurologic Manifestations; Lubiprostone; Chloride Channel Agonists; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action