Lubiprostone Effects on Visceral Pain Sensitivity

Irritable Bowel Syndrome Clinical Trial

Official title:

Lubiprostone Effects on Visceral Pain Sensitivity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01166789
• Other study ID #: 07-004L
• Status: Completed
• Phase: Phase 1
• First received: July 19, 2010
• Last updated: September 14, 2011
• Start date: February 2008
• Est. completion date: August 2010

Study information

• Verified date: September 2011
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Visceral Pain

Intervention

Drug:
• Lubiprostone
48ug daily taken as 24ug capsules twice per day, in morning and evening.
• Placebo
2 capsules daily, taken in morning and evening

Locations

Country	Name	City	State
United States	UNC Clinical and Translational Research Center	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Takeda

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain threshold		2 weeks	No