The Impact of Lubiprostone on Mucus Secretion in Asymptomatic Volunteers and Patients With Chronic Constipation

This study is currently recruiting participants.

Verified by University of Kansas, March 2009

First Received: January 7, 2008 Last Updated: March 26, 2009 History of Changes

Sponsors and Collaborators:	University of Kansas Takeda Global Research & Development Center, Inc.
Information provided by:	University of Kansas
ClinicalTrials.gov Identifier:	NCT00595036

Purpose

This study is going to investigate if lubiprostone, the FDA approved drug for constipation, may effect production of digestive juice and other viscous-like substances in the stomach in healthy volunteers and patients diagnosed with constipation. Based on the mechanism of action of lubiprostone, it is possible to believe that this drug is able to effect not only the colon but also the stomach with increasing production of the important enzymes and protective digestive substances.

Condition	Intervention	Phase
Constipation	Drug: Lubiprostone Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	The Impact of Lubiprostone on Mucus Secretion in Asymptomatic Volunteers and Patients With Chronic Constipation

Resource links provided by NLM:

MedlinePlus related topics: Constipation

Drug Information available for: Lubiprostone

U.S. FDA Resources

Further study details as provided by University of Kansas:

Primary Outcome Measures:

Effect of gastric mucus and mucin production before and after stimulation with lubiprostone in healthy and constipated subjects [ Time Frame: 3 Weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Viscosity of gastric secretion before and after lubiprostone in healthy and constipated subjects [ Time Frame: 3 Weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	January 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Lubiprostone Lubiprostone 24 mcg
2: Placebo Comparator	Drug: Placebo Placebo

Detailed Description:

This study is designed to learn if there is any correlation between treatment of constipation and similar response in gastric activities achieved by lubiprostone. The short duration of the treatment phase is not expected to alleviate the symptoms of constipation but rather to answer scientific questions related to improvement of secretion in the GI tract.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Symptomatic: 6 month history of constipation

Exclusion Criteria:

Pregnancy or planning to become pregnant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00595036

Contacts

Contact: Irene Sarosiek, MD

(913) 588-3852

isarosie@kumc.edu

Locations

United States, Kansas
University of Kansas Medical Center	Recruiting
Kansas City, Kansas, United States, 66160
Contact: Irene Sarosiek, MD 913-588-3852 isarosie@kumc.edu
Principal Investigator: Jerzy Sarosiek, MD, PhD

Sponsors and Collaborators

University of Kansas

Takeda Global Research & Development Center, Inc.

Investigators

Principal Investigator:

Jerzy Sarosiek, MD, PhD

University of Kansas

More Information

No publications provided

Responsible Party:	University of Kansas Medical Center ( Jerzy Sarosiek, MD, PhD )
Study ID Numbers:	11029
Study First Received:	January 7, 2008
Last Updated:	March 26, 2009
ClinicalTrials.gov Identifier:	NCT00595036 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms
Signs and Symptoms, Digestive
Constipation

Additional relevant MeSH terms:

Signs and Symptoms
Signs and Symptoms, Digestive
Constipation

ClinicalTrials.gov processed this record on August 30, 2009