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

This study has been completed.
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Sucampo Pharma Americas, LLC ( Sucampo Pharmaceuticals, Inc. )
ClinicalTrials.gov Identifier:
NCT01298219
First received: January 20, 2011
Last updated: February 1, 2013
Last verified: February 2013
  Purpose

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

OBD.


Condition Intervention Phase
Opioid-induced Bowel Dysfunction
Drug: Lubiprostone
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Sucampo Pharma Americas, LLC:

Primary Outcome Measures:
  • Overall SBM response rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in SBM frequency [ Time Frame: Week 8, 12 and Overall ] [ Designated as safety issue: No ]
  • First post-dose SBM (percentage of patients) [ Time Frame: 24 and 48 hours post-dose ] [ Designated as safety issue: No ]
  • Responder rates [ Time Frame: Week 1 through Week 12 ] [ Designated as safety issue: No ]
  • Mean changes from baseline in straining, stool consistency, constipation severity, abdominal bloating, abdominal discomfort, bowel habit regularity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Treatment effectiveness [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Health related quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 447
Study Start Date: December 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2 Drug: Lubiprostone
24 mcg capsules twice daily (BID)
Placebo Comparator: 1 Drug: Placebo
0 mcg capsules twice daily (BID)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

study.

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01298219

  Show 142 Study Locations
Sponsors and Collaborators
Sucampo Pharmaceuticals, Inc.
Takeda
Investigators
Principal Investigator: Mazen Jamal, MD, MPH UCI College of Medicine
  More Information

No publications provided

Responsible Party: Sucampo Pharma Americas, LLC ( Sucampo Pharmaceuticals, Inc. )
ClinicalTrials.gov Identifier: NCT01298219     History of Changes
Other Study ID Numbers: OBD1033
Study First Received: January 20, 2011
Last Updated: February 1, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants

ClinicalTrials.gov processed this record on July 28, 2014