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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01298219
Recruitment Status : Completed
First Posted : February 17, 2011
Last Update Posted : February 5, 2013
Information provided by (Responsible Party):
Sucampo Pharma Americas, LLC ( Sucampo Pharmaceuticals, Inc. )

Brief Summary:

The primary purpose of the study is to evaluate the efficacy and safety of lubiprostone administration in subjects with


Condition or disease Intervention/treatment Phase
Opioid-induced Bowel Dysfunction Drug: Lubiprostone Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 447 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Placebo-controlled, Double-blinded Study of the Efficacy and Safety of Lubiprostone in Subjects With Opioid-induced Bowel Dysfunction
Study Start Date : December 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 2 Drug: Lubiprostone
24 mcg capsules twice daily (BID)

Placebo Comparator: 1 Drug: Placebo
0 mcg capsules twice daily (BID)

Primary Outcome Measures :
  1. Overall SBM response rate [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in SBM frequency [ Time Frame: Week 8, 12 and Overall ]
  2. First post-dose SBM (percentage of patients) [ Time Frame: 24 and 48 hours post-dose ]
  3. Responder rates [ Time Frame: Week 1 through Week 12 ]
  4. Mean changes from baseline in straining, stool consistency, constipation severity, abdominal bloating, abdominal discomfort, bowel habit regularity [ Time Frame: 12 weeks ]
  5. Treatment effectiveness [ Time Frame: 12 weeks ]
  6. Health related quality of life [ Time Frame: 12 weeks ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Consistent treatment for chronic, non-cancer-related pain with any oral, transdermal, intravenous, or subcutaneous opioid (full

agonist) other than methadone for at least 30 days prior to screening, and will continue opioid therapy throughout the study.

Diagnosis of opioid-induced bowel dysfunction (OBD) as confirmed during the screening period.

If patient has a history of chronic constipation (>90days), condition must have been exacerbated by initiation of opioid

treatment. Use of prescribed or OTC medication that affects gastrointestinal motility (other than opioid therapy) must be discontinued from the

screening visit through the completion of the study. If treated for clinical depression with SSRIs, SNRIs, or MAO inhibitors, treatment must have been at a stable dose for at least 30

days prior to screening and not likely to change during the study. Patient must discontinue use of laxatives and stool softeners (with the exception of approved rescue medications) while on


Exclusion Criteria:

Treatment with opioid therapy for cancer-related pain, abdominal pain, scleroderma, and/or for the management of drug

addiction. Patient has current evidence of, or has been treated for, cancer within the past 5 years (with the exception of localized basal

cell, squamous cell skin cancer, or in situ cancer that has been resected). Changes in opioid treatment, route of administration or dose adjustments (increased or decreased by +/-30% in morphine equivalent

daily dose [MEDD] of opioid treatment) within 30 days of screening, or likelihood of opioid discontinuation over the course of the study.

Gastrointestinal or abdominal surgical procedures within 90 days prior to screening or has had a bowel resection at any time.

Non-ambulatory patients or those who are unable to eat/drink, take oral medications, or to hold down oral medications due to

vomiting. Female patients of childbearing potential who are unable/unwilling to use protocol-specified method(s) of birth control and/or are

pregnant, nursing, or plan to become pregnant or nurse during the study. Prior use of Amitiza, lubiprostone, SPI-0211, or RU-0211. Patients receiving methadone, methadone HCl, or a congener of methadone either alone or as part of opioid regimen.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01298219

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Sponsors and Collaborators
Sucampo Pharmaceuticals, Inc.
Principal Investigator: Mazen Jamal, MD, MPH UCI College of Medicine

Responsible Party: Sucampo Pharmaceuticals, Inc. Identifier: NCT01298219     History of Changes
Other Study ID Numbers: OBD1033
First Posted: February 17, 2011    Key Record Dates
Last Update Posted: February 5, 2013
Last Verified: February 2013

Additional relevant MeSH terms:
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Chloride Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action