Opioid-induced Bowel Dysfunction (OBD) Pivotal Assessment of Lubiprostone (OPAL)

Completed · Phase 3 · Has a placebo group

Conditions studied: Opioid-induced Bowel Dysfunction

In brief

The primary purpose of the study is to evaluate the efficacy and safety of lubiprostone administration in subjects with Opioid-induced Bowel Dysfunction.

Key facts

Study ID

NCT01298219

Run by

Sucampo Pharma Americas, LLC

People needed

439

Starts

2010-12-01

Expected to finish

2011-11-01

Last updated by the study team

2020-02-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A patient can be considered for eligibility to participate if he/she:
• Has been consistently treated for chronic, noncancer-related pain with any oral, transdermal, intravenous, or subcutaneous opioid for at least 30 days prior to screening
• Is diagnosed with OBD
• Is capable of utilizing an electronic diary to report daily spontaneous bowel movements (SBMs)
• Is willing to continue opioid therapy and discontinue the use of laxatives, stool softeners, and other concomitant medications affecting gastrointestinal motility throughout the study

You may not qualify if…

• A patient cannot be considered for eligibility to participate if he/she:
• Uses opioids for the treatment of cancer-related pain, abdominal pain, mechanical bowel obstructions, bowel disorders, and constipation not arising from opioid use, but instead attributable to dietary, neurologic, congenital, or endocrine disorders, scleroderma, and/or for the management of drug addiction

Where it is running

• Innovative Clinical Trials, Inc. — Birmingham, Alabama, United States
• Achieve Clinical Research — Birmingham, Alabama, United States
• Alabama Clinical Therapeutics — Birmingham, Alabama, United States
• G&L Research, LLC — Foley, Alabama, United States
• Healthscan Research — Montgomery, Alabama, United States
• River Region Research — Tallassee, Alabama, United States
• Anasazi Internal Medicine PC — Phoenix, Arizona, United States
• Aureas Research, Inc — Little Rock, Arkansas, United States
• Certified Clinical Research — Carmichael, California, United States
• California Clinical Research, Inc. — Davis, California, United States
• Family Medical Center — Foothill Ranch, California, United States
• South Orange County Surgical Medical Group — Laguna Hills, California, United States
• Clinical Trials Research — Lincoln, California, United States
• Clear Vision Research — Long Beach, California, United States
• Long Beach VA Medical Center — Long Beach, California, United States
• Clear Vision Research — Los Angeles, California, United States
• Facey Medical Foundation — Mission Hills, California, United States
• North County Clinical Research — Oceanside, California, United States
• SDS Clinical Trials, Inc. — Orange, California, United States
• Probe Clinical Research Corporation — Riverside, California, United States
• Probe Clinical Research Corporation - Santa Ana — Santa Ana, California, United States
• Westlake Medical Research — Westlake Village, California, United States
• Mountain View Clinical Research — Denver, Colorado, United States
• Meridien Research — Bradenton, Florida, United States
• North Alabama Research Center — Athens, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.