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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.
 
ClinicalTrials.gov Identifier: NCT00597428
Recruitment Status : Completed
First Posted : January 18, 2008
Results First Posted : December 7, 2015
Last Update Posted : December 10, 2019
Sponsor:
Collaborator:
Sucampo Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Mallinckrodt ( Sucampo Pharma Americas, LLC )

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Opioid-Induced Bowel Dysfunction Drug: Lubiprostone Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 437 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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)
Study Start Date : August 2007
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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®


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 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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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 ClinicalTrials.gov identifier (NCT number): NCT00597428


Locations
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Sponsors and Collaborators
Sucampo Pharma Americas, LLC
Sucampo Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Egilius L.H. Spierings, M.D., Ph.D. MedVadis Research Corporation
More Information
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Responsible Party: Sucampo Pharma Americas, LLC
ClinicalTrials.gov Identifier: NCT00597428    
Other Study ID Numbers: OBD0632
First Posted: January 18, 2008    Key Record Dates
Results First Posted: December 7, 2015
Last Update Posted: December 10, 2019
Last Verified: November 2015
Additional relevant MeSH terms:
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Intestinal Diseases
Gastrointestinal Diseases
Opioid-Induced Constipation
Digestive System Diseases
Constipation
Signs and Symptoms, Digestive
Narcotic-Related Disorders
 Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Lubiprostone
Chloride Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action