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

This study has been completed.
Information provided by (Responsible Party):
Sucampo Pharma Americas, LLC ( Sucampo Pharmaceuticals, Inc. ) Identifier:
First received: January 9, 2008
Last updated: November 2, 2015
Last verified: November 2015
The primary purpose of this study is to evaluate the efficacy and safety of lubiprostone administration in patients with opioid-induced bowel dysfunction (OBD).

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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 Mean Weekly Spontaneous Bowel Movement (SBM) Frequency in Subjects Without Dose Reduction Prior to Week 8 [ Time Frame: Baseline and Week 8 ]

Secondary Outcome Measures:
  • Change From Baseline in Mean Weekly SBM Frequency [ Time Frame: Baseline, Week 12, and Weeks 1-12 ]
    For overall assessment of change, average weekly rating was calculated from data collected from Week 1 through Week 12.

  • First Post-dose SBM [ Time Frame: 24 and 48 hours post-dose ]
    The number of participants that experienced first post-dose SBM 24 and 48 hour of dose initiation.

  • Responder Rate [ Time Frame: Up to 12 weeks ]
    Number of participants, who remained on treatment for at least 8 weeks, and reported response (>=3 SBMs) for at least 50% of weeks on study.

  • Mean Changes From Baseline in Straining, Stool Consistency, Constipation Severity, Abdominal Bloating, Abdominal Discomfort, and Bowel Habit Regularity [ Time Frame: Weeks 1-12 ]
    Ratings over 12-week treatment period were averaged and difference from baseline score calculated Straining scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Stool consistency scale: 0 = very loose, 1 = loose, 2 = normal, 3 = hard, 4 = very hard (little balls) Constipation severity scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Abdominal bloating scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Abdominal discomfort scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Bowel habit regularity scale: 7-point scale, where 1 = very regular and 7 = very irregular

  • Treatment Effectiveness [ Time Frame: Weeks 1-12 ]
    Treatment effectiveness scale: 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, 4 = extremely effective

Enrollment: 437
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: Placebo
0 mcg capsules twice daily (BID)
Drug: Placebo
0 mcg capsules twice daily (BID)
Other Name: No other names
Experimental: Lubiprostone
24 mcg capsules twice daily (BID)
Drug: Lubiprostone
24 mcg capsules twice daily (BID)
Other Name: Amitiza®


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

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 over-the-counter (OTC) medication that affects gastrointestinal motility (other than opioid therapy) must be discontinued during the study.
  • If treated for clinical depression with selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), or monoamine oxidase (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:

  • Opioid dose adjustment (+/- 30%), and/or change in opioid agent or route of administration within 30 days of screening.
  • Non-ambulatory patients, or those who are unable to eat/drink, take oral medications, or to hold down oral medications due to vomiting.
  • 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).
  • Gastrointestinal or abdominal surgical procedures within 90 days prior to screening.
  • 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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00597428

  Show 114 Study Locations
Sponsors and Collaborators
Sucampo Pharmaceuticals, Inc.
Principal Investigator: Egilius L.H. Spierings, M.D., Ph.D. MedVadis Research Corporation
  More Information

Responsible Party: Sucampo Pharmaceuticals, Inc. Identifier: NCT00597428     History of Changes
Other Study ID Numbers: OBD0632
Study First Received: January 9, 2008
Results First Received: November 22, 2013
Last Updated: November 2, 2015

Additional relevant MeSH terms:
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Chloride Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action processed this record on May 22, 2017