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

Phase 3

Completed

• Conditions: Opioid-induced Bowel Dysfunction
• Interventions: Drug: Placebo; Drug: Lubiprostone

• Registration Number: NCT01298219
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-01-20
• Study First Submitted QC: 2011-02-15
• Study First Posted: 2011-02-17
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2013-02
• Disposition First Submitted: 2013-02-01
• Disposition First Submitted QC: 2013-02-01
• Disposition First Posted: 2013-02-05
• Results First Submitted: 2019-12-02
• Results First Submitted QC: 2019-12-06
• Results First Posted: 2019-12-24
• Last Update Submitted: 2020-02-03
• Last Update Posted: 2020-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 439

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	0 mcg capsules twice daily (BID)
Lubiprostone	Lubiprostone	24 mcg capsules twice daily (BID)

Primary Outcome Measures

Name	Time	Method
Number of Participants Classified as Treatment Responders Within 12 Weeks	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

Name	Time	Method
Number of SBMs Per Week at Week 12	at Week 12
Number of SBMs Per Week Overall	within 14 weeks	Overall is defined as the length of time from first dose to last follow-up within 2 weeks after last dose.
Number of SBMs Per Week at Week 8	at Week 8
Number of Participants Who Experienced First SBM Within 48 Hours After Dose Initiation	within 48 hours post-dose

Trial Locations

Locations (140)

North Alabama Research Center; 🇺🇸 Athens, Alabama, United States

Innovative Clinical Trials, Inc.; 🇺🇸 Birmingham, Alabama, United States

Achieve Clinical Research; 🇺🇸 Birmingham, Alabama, United States

Alabama Clinical Therapeutics; 🇺🇸 Birmingham, Alabama, United States

G&L Research, LLC; 🇺🇸 Foley, Alabama, United States

Healthscan Research; 🇺🇸 Montgomery, Alabama, United States

River Region Research; 🇺🇸 Tallassee, Alabama, United States

Anasazi Internal Medicine PC; 🇺🇸 Phoenix, Arizona, United States

Aureas Research, Inc; 🇺🇸 Little Rock, Arkansas, United States

Certified Clinical Research; 🇺🇸 Carmichael, California, United States

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