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Opioid-induced Bowel Dysfunction (OBD) 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: NCT01298219
Recruitment Status : Completed
First Posted : February 17, 2011
Results First Posted : December 24, 2019
Last Update Posted : February 11, 2020
Sponsor:
Collaborator:
Sucampo Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Mallinckrodt ( Sucampo Pharma Americas, LLC )

Brief Summary:
The primary purpose of the study is to evaluate the efficacy and safety of lubiprostone administration in subjects with Opioid-induced Bowel Dysfunction.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 439 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Care provider and outcomes assessor were also blinded for this double-blind trial.
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: Lubiprostone
24 mcg capsules twice daily (BID)
Drug: Lubiprostone
24 mcg administered orally twice daily (BID)
Other Name: Amitiza

Placebo Comparator: Placebo
0 mcg capsules twice daily (BID)
Drug: Placebo
Matching placebo, 0 mcg administered orally twice daily (BID)
Other Name: No other names




Primary Outcome Measures :
  1. Number of Participants Classified as Treatment Responders Within 12 Weeks [ Time Frame: 12 weeks ]
    Spontaneous bowel movement (SBM) is defined as any BM that does not occur within 24 hours after use of rescue medication. To be classified as responders, participants are required to demonstrate at least moderate response (≥ 1 SBM improvement over baseline SBM frequency) for all treatment weeks for which observed data are available, and must additionally demonstrate a full response (≥ 3 SBMs per week) for at least 9 of the 12 treatment weeks.


Secondary Outcome Measures :
  1. Number of SBMs Per Week at Week 8 [ Time Frame: at Week 8 ]
  2. Number of Participants Who Experienced First SBM Within 48 Hours After Dose Initiation [ Time Frame: within 48 hours post-dose ]
  3. Number of SBMs Per Week at Week 12 [ Time Frame: at Week 12 ]
  4. Number of SBMs Per Week Overall [ Time Frame: within 14 weeks ]
    Overall is defined as the length of time from first dose to last follow-up within 2 weeks after last dose.



Information from the National Library of Medicine

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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:

A patient can be considered for eligibility to participate if he/she:

  • Has been consistently treated for chronic, noncancer-related pain with any oral, transdermal, intravenous, or subcutaneous opioid for at least 30 days prior to screening
  • Is diagnosed with OBD
  • Is capable of utilizing an electronic diary to report daily spontaneous bowel movements (SBMs)
  • Is willing to continue opioid therapy and discontinue the use of laxatives, stool softeners, and other concomitant medications affecting gastrointestinal motility throughout the study

Exclusion Criteria:

A patient cannot be considered for eligibility to participate if he/she:

  • Uses opioids for the treatment of cancer-related pain, abdominal pain, mechanical bowel obstructions, bowel disorders, and constipation not arising from opioid use, but instead attributable to dietary, neurologic, congenital, or endocrine disorders, scleroderma, and/or for the management of drug addiction

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): NCT01298219


Locations
Show Show 142 study locations
Sponsors and Collaborators
Sucampo Pharma Americas, LLC
Sucampo Pharmaceuticals, Inc.
Investigators
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Study Director: Clinical Study Leader Mallinckrodt
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Responsible Party: Sucampo Pharma Americas, LLC
ClinicalTrials.gov Identifier: NCT01298219    
Other Study ID Numbers: OBD1033
First Posted: February 17, 2011    Key Record Dates
Results First Posted: December 24, 2019
Last Update Posted: February 11, 2020
Last Verified: February 2013
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Lubiprostone
Chloride Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action