Evaluation of the Efficacy and Safety of Lubiprostone in Adults With Mixed or Unsubtyped Irritable Bowel Syndrome



Status:Recruiting
Conditions:Irritable Bowel Syndrome (IBS)
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:7/8/2016
Start Date:February 2015
End Date:December 2016
Contact:Shadreck M Mareya, PhD
Email:info@sucampo.com
Phone:301-961-3400

Use our guide to learn which trials are right for you!

A Randomized, Double-blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Lubiprostone in Adult Subjects With Mixed or Unsubtyped Irritable Bowel Syndrome (IBS-M/IBS-U)

A study of the efficacy and safety of Lubiprostone in subjects diagnosed with IBS-M/IBS-U.

To assess the efficacy and safety of oral lubiprostone, as compared to matching placebo,
when administered orally (at 8 mcg twice daily [BID]) in subjects diagnosed with
IBS-M/IBS-U.

Inclusion Criteria:

- Subject meets the diagnosis of IBS-M or IBS-U as confirmed using the adapted ROME III
Diagnostic Questionnaire for Adult Functional GI Disorders.

- Subject Screening diary entries must show an average worst abdominal pain in the past
24 hours score of at least 4 on a 11-point scale.

- Subject must be on a stable dose of selective serotonin re-uptake inhibitors (SSRIs),
serotonin-specific reuptake inhibitor (SNRIs), or monoamine oxidase inhibitors (MAO)
inhibitors if taking antidepressants.

Exclusion Criteria:

- Subject has current diagnosis of IBS with diarrhea (IBS-D) or IBS with constipation
(IBS-C), according to Rome III Criteria.

- Any gastrointestinal (GI) condition, other than IBS-related, affecting GI motility or
defecation.

- Medical/surgical condition that might interfere with the absorption, distribution,
metabolism, or excretion of the study medication.
We found this trial at
21
sites
Rochester, Minnesota 55905
?
mi
from
Rochester, MN
Click here to add this to my saved trials
Charlotte, North Carolina 28209
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Chula Vista, California 91910
?
mi
from
Chula Vista, CA
Click here to add this to my saved trials
Concord, North Carolina 28025
?
mi
from
Concord, NC
Click here to add this to my saved trials
Fayetteville, North Carolina 28304
?
mi
from
Fayetteville, NC
Click here to add this to my saved trials
Hagerstown, Maryland 21740
?
mi
from
Hagerstown, MD
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
Huntsville, Alabama 35801
?
mi
from
Huntsville, AL
Click here to add this to my saved trials
Jackson, Tennessee 38305
?
mi
from
Jackson, TN
Click here to add this to my saved trials
Johns Creek, Georgia 30097
?
mi
from
Johns Creek, GA
Click here to add this to my saved trials
Laguna Hills, California 92653
?
mi
from
Laguna Hills, CA
Click here to add this to my saved trials
Little Rock, Arkansas 72205
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
McKinney, TX
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
Nashville, Tennessee 37205
?
mi
from
Nashville, TN
Click here to add this to my saved trials
North Little Rock, Arkansas
?
mi
from
North Little Rock, AR
Click here to add this to my saved trials
Palm Harbor, Florida 34684
?
mi
from
Palm Harbor, FL
Click here to add this to my saved trials
?
mi
from
Plano, TX
Click here to add this to my saved trials
3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Rialto, California 92377
?
mi
from
Rialto, CA
Click here to add this to my saved trials