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Completed

NCT Number: NCT01298219

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

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

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Key information

Conditions

Opioid-Induced Bowel Dysfunction Chemically-Induced Disorders Constipation Mental Disorders Narcotic-Related Disorders Opioid-Induced Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pain Clinic-Heilig Hart Ziekenhuis Roeselare, Roeselare, Westlaan 123, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lubiprostone

Drug

24 mcg administered orally twice daily (BID)

Other names: Amitiza

Placebo

Drug

Matching placebo, 0 mcg administered orally twice daily (BID)

Other names: No other names

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Sucampo Pharma Americas, LLC

Industry

Collaborators

  • Sucampo Pharmaceuticals, Inc.

Registry information

Official study title

A Multicenter, Randomized, Placebo-controlled, Double-blinded Study of the Efficacy and Safety of Lubiprostone in Subjects With Opioid-induced Bowel Dysfunction

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 17, 2011
Registry last updated
Feb 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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