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:
NCT00595946
First received: January 4, 2008
Last updated: February 1, 2013
Last verified: February 2013
  Purpose

The primary purpose of this study is to evaluate the efficacy and safety of lubiprostone administration in patients 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 Multi-center, Randomized, Double-Blinded Study of the Efficacy and Safety of Lubiprostone in Patients With Opioid-induced Bowel Dysfunction (OBD)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change from baseline in SBM frequency [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in SBM frequency [ Time Frame: Week 12 and Overall (average weekly rating) ] [ 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 rate [ Time Frame: Overall (average weekly rating) ] [ Designated as safety issue: No ]
  • Mean changes from baseline in straining, stool consistency, constipation severity, abdominal bloating, abdominal discomfort, and bowel habit regularity [ Time Frame: Overall (average weekly rating) ] [ Designated as safety issue: No ]
  • Treatment effectiveness (patient reported outcome) [ Time Frame: Overall (average weekly rating) ] [ Designated as safety issue: No ]
    5 point scale used to rate patient evaluation of treatment effectiveness


Enrollment: 441
Study Start Date: August 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: Placebo
0 mcg capsules twice daily (BID)
Experimental: 2 Drug: Lubiprostone
24 mcg capsules twice daily (BID)
Other Name: Amitiza®

  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 full agonist opioid for at least 30 days prior to screening.
  • Diagnosis of opioid-induced bowel dysfunction as confirmed during the screening period.
  • If patient has a history of chronic constipation, 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 during 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.
  • Use of laxative and stool softeners (with the exception of approved rescue medications) must be discontinued 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 been treated for cancer in the past 5 years (with the exception of localized basal cell, squamous cell skin cancer, or in situ cancer that has been resected).
  • Opioid dose adjustment (+/- 30%), and/or change in opioid agent or route of administration within 30 days of screening.
  • Gastrointestinal or abdominal surgical procedures within 90 days prior to screening.
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00595946

  Show 95 Study Locations
Sponsors and Collaborators
Sucampo Pharmaceuticals, Inc.
Takeda
Investigators
Principal Investigator: Carol A. Burke, M.D. The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Sucampo Pharma Americas, LLC ( Sucampo Pharmaceuticals, Inc. )
ClinicalTrials.gov Identifier: NCT00595946     History of Changes
Other Study ID Numbers: OBD0631
Study First Received: January 4, 2008
Last Updated: February 1, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

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 April 17, 2014