Lubiprostone Effects on Visceral Pain Sensitivity

NCT01166789 | Completed Phase 1

• 1 other identifier: 07-004L
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome

Keywords

IBS; pain threshold; constipation

Outcome Measures

Primary Outcomes (1)

• Pain threshold

  2 weeks

Study Arms (2)

Lubiprostone

ACTIVE COMPARATOR

Lubiprostone 48ug taken daily for 14 days.

Drug: Lubiprostone

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Lubiprostone DRUG

48ug daily taken as 24ug capsules twice per day, in morning and evening.

Also known as: Amitiza

Lubiprostone

Placebo DRUG

2 capsules daily, taken in morning and evening

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• clinical diagnosis of IBS-C
• meeting Rome III diagnostic criteria for IBS-C
• age 18 or older

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Takeda: collaborator

Study Sites (1)

UNC Clinical and Translational Research Center

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome; Constipation

Interventions

Lubiprostone

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alprostadil; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Study Officials

• William E Whitehead, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: July 19, 2010
• First Posted: July 21, 2010
• Study Start: February 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: September 16, 2011

Record last verified: 2011-09

Locations

US (1)