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
1228
mi
from 91732
McKinney, TX
Click here to add this to my saved trials
Charlotte, North Carolina 28209
2101
mi
from 91732
Charlotte, NC
Click here to add this to my saved trials
Chula Vista, California 91910
113
mi
from 91732
Chula Vista, CA
Click here to add this to my saved trials
Concord, North Carolina 28025
2114
mi
from 91732
Concord, NC
Click here to add this to my saved trials
Fayetteville, North Carolina 28304
2208
mi
from 91732
Fayetteville, NC
Click here to add this to my saved trials
Hagerstown, Maryland 21740
2240
mi
from 91732
Hagerstown, MD
Click here to add this to my saved trials
1343
mi
from 91732
Houston, TX
Click here to add this to my saved trials
Huntsville, Alabama 35801
1784
mi
from 91732
Huntsville, AL
Click here to add this to my saved trials
Jackson, Tennessee 38305
1653
mi
from 91732
Jackson, TN
Click here to add this to my saved trials
Johns Creek, Georgia 30097
1872
mi
from 91732
Johns Creek, GA
Click here to add this to my saved trials
Laguna Hills, California 92653
38
mi
from 91732
Laguna Hills, CA
Click here to add this to my saved trials
Little Rock, Arkansas 72205
1463
mi
from 91732
Little Rock, AR
Click here to add this to my saved trials
13
mi
from 91732
Los Angeles, CA
Click here to add this to my saved trials
2320
mi
from 91732
Miami, FL
Click here to add this to my saved trials
Nashville, Tennessee 37205
1759
mi
from 91732
Nashville, TN
Click here to add this to my saved trials
North Little Rock, Arkansas
1464
mi
from 91732
North Little Rock, AR
Click here to add this to my saved trials
Palm Harbor, Florida 34684
2117
mi
from 91732
Palm Harbor, FL
Click here to add this to my saved trials
1219
mi
from 91732
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...
2214
mi
from 91732
Raleigh, NC
Click here to add this to my saved trials
Rialto, California 92377
35
mi
from 91732
Rialto, CA
Click here to add this to my saved trials
Rochester, Minnesota 55905
1524
mi
from 91732
Rochester, MN
Click here to add this to my saved trials