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Opioid-induced Bowel Dysfunction: Long-Term Assessment of Lubiprostone

Information source: Sucampo Pharma Americas, LLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Opioid-Induced Bowel Dysfunction

Intervention: Lubiprostone (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Sucampo Pharmaceuticals, Inc.

Summary

The purpose of this study is to evaluate the long-term safety and efficacy of lubiprostone administration in patients with OBD.

Clinical Details

Official title: A Multi-center, Open-labeled Study of the Long-term Safety and Efficacy of Lubiprostone in Patients With Opioid-induced Bowel Dysfunction

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Evaluation of overall safety, including AEs; clinical laboratory evaluations; vital signs; 12-lead resting electrocardiograms; and physical examination results.

Secondary outcome:

Change from baseline in spontaneous bowel movement (SBM) and bowel movement (BM) frequency

Frequency of SBMs and BMs

Responder rates

Mean change from baseline in straining associated with SBMs; stool consistency of SBMs; constipation severity; treatment effectiveness; abdominal bloating; and abdominal discomfort.

Mean change from baseline in bowel habit regularity

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patient has completed 12 weeks of blinded treatment in the SPI/0211OBD-0631 or

SPI/0211OBD-0632 study.

- Patient will continue to be treated consistently for chronic, non-cancer-related pain

with any full agonist opiate and will continue opiate therapy for the duration of the study.

- Patient must be willing to continue to abstain from use of disallowed medications as

defined per protocol. Exclusion Criteria:

- Patient has newly diagnosed impaired renal function identified at the Screening Visit

(i. e., serum creatinine concentration > 1. 8 mg/dL).

- Patient has experienced an unexplained and/or clinically significant weight loss

defined as > 5% within 90 days prior to Screening Visit.

- Patient plans to participate in another trial with an investigational drug or device

during the course of the extension study.

Locations and Contacts

Alabama Orthopedic Clinic, Mobile, Alabama 36608, United States

Clinical Research Advantage, Inc./ Mesa Family Medical Center, Mesa, Arizona 85203, United States

Clinical Research Advantage, Inc., Tempe, Arizona 85282, United States

Clinical Research Advantage, Inc. / East Valley Family Physicians, PLC, Tempe, Arizona 85222, United States

Premiere Pharamaceutical Research, LLC, Tempe, Arizona 85282, United States

Advanced Clinical Therapeutics, LLC, Tucson, Arizona 85712, United States

Wilson and Charani, Tucson, Arizona 85741, United States

Advanced Clinical Research Institute, Anaheim, California 92801, United States

Northern California Research Corporation, Sacramento, California 95831, United States

Clinicos, LLC, Colorado Springs, Colorado 80904, United States

Clinical Physiology Associates/Clinical Study Center, Fort Meyers, Florida 33916, United States

Century Clinical Research, Holly Hill, Florida 32117, United States

Florida Institute of Medical Research, Jacksonville, Florida 32257, United States

Accord Clinical Research, LLC, Port Orange, Florida 32129, United States

Clinical Research of West Florida, Inc., Tampa, Florida 33603, United States

Stedman Clinical Trials, Tampa, Florida 33613, United States

Best Clinical Research, Decatur, Georgia 30034, United States

Millenium Pain Center, Bloomington, Illinois 61701, United States

Columbia Medical Practice/ RxTrials, Inc., Columbia, Maryland 21045, United States

MedVadis Research Corporation, Wellesley Hills, Massachusetts 02481, United States

Center for Digestive Health, Troy, Michigan 48098, United States

Montana Neuroscience Institute Foundation / Montana Spine and Pain Center, Missoula, Montana 59802, United States

Office of Stephen H. Miller, MD, Las Vegas, Nevada 89106, United States

Long Island Gastrointestinal Research Group, Great Neck, New York 11023, United States

COR Clinical Research, LLC, Oklahoma City, Oklahoma 73103, United States

Memorial Clinical Research, Oklahoma City, Oklahoma 73134, United States

Medford Medical Clinic, LLP, Medford, Oregon 97504, United States

Trident Institute of Medical Research, LLC, North Charleston, South Carolina 29406, United States

Southeastern Clinical Research, Chattanooga, Tennessee 37403, United States

Comprehensive Pain Specialists, PLLC, Hendersonville, Tennessee 37075, United States

New River Valley Research Institute, Christianburg, Virginia 24073, United States

Additional Information

Starting date: November 2007
Last updated: February 1, 2013

Page last updated: August 23, 2015

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