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Completed

NCT Number: NCT00595946

Opioid-induced Bowel Dysfunction: Pivotal Assessment of Lubiprostone

The primary purpose of this study is to evaluate the efficacy and safety of lubiprostone administration in patients 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

Health Sciences Center, Hamilton, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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 (OBD) 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 inhibitor (SSRIs), Serotonin-norepinephrine reuptake inhibitor (SNRIs), or Monoamine oxidase inhibitor (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

  • 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).
  • Opioid dose adjustment (+/- 30%), and/or change in opioid agent or route of administration within 30 days of screening.
  • Gastrointestinal or abdominal surgical procedures within 90 days prior to screening.
  • Non-ambulatory patients, or those who are unable to eat/drink, take oral medications, or to hold down oral medications due to vomiting.
  • 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.
  • Prior use of Amitiza, lubiprostone, SPI-0211, or RU-0211.

Treatment and study plan

Lubiprostone

Drug

24 mcg capsules twice daily (BID)

Other names: Amitiza®

Placebo

Drug

0 mcg capsules twice daily (BID)

Other names: No other names

Primary outcomes

  1. Mean Weekly Spontaneous Bowel Movements at Week 8

    Time frame: at Week 8

    Spontaneous bowel movements (SBMs) are defined as bowel movements without the aid of drugs.

Secondary outcomes

  1. Mean Number of Spontaneous Bowel Movements (SBM) Per Week Within 12 Weeks

    Time frame: within 12 weeks

    Average weekly SBM frequency was calculated from data collected from Week 1 through Week 12

  2. Number of Participants With the First Post-dose Spontaneous Bowel Movement Within 48 Hours Post-dose

    Time frame: within 48 hours post-dose

    The number of participants who experienced their first post-dose Spontaneous Bowel Movement within 24 and 48 hours after dosing started.

  3. Number of Participants Classified as Responders

    Time frame: within 12 weeks

    Number of participants who remained on treatment for at least 8 weeks, and reported at least 3 SBMs for at least half the weeks on study.

  4. Mean Change From Baseline in Straining, Stool Consistency, Constipation Severity, Abdominal Bloating, Abdominal Discomfort, and Bowel Habit Regularity

    Time frame: within 12 weeks

    Measures collected over 12-week treatment period were averaged, and the score at baseline was subtracted from the score at week 12 to determine the change from baseline.

    Straining scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe - higher scores are worse;

    Stool consistency scale: 0 = very loose, 1 = loose, 2 = normal, 3 = hard, 4 = very hard (little balls) - middle scores are best;

    Constipation severity scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe - higher scores are worse;

    Abdominal bloating scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe - higher scores are worse;

    Abdominal discomfort scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe - higher scores are worse;

    Bowel habit regularity scale: 7-point scale, where 1 = very regular and 7 = very irregular - higher scores are worse

  5. Participant Reported Outcome of Treatment Effectiveness

    Time frame: within 12 weeks

    Participants rated treatment effectiveness at the end of each treatment week during the study on a 5-point scale, where 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, 4 = extremely effective. The 12 weekly scores were averaged. Higher scores mean the drug was more effective.

Sponsors and collaborators

Lead sponsor

Sucampo Pharma Americas, LLC

Industry

Collaborators

  • Sucampo Pharmaceuticals, Inc.

Registry information

Official study title

A Multi-center, Randomized, Double-Blinded Study of the Efficacy and Safety of Lubiprostone in Patients With Opioid-induced Bowel Dysfunction (OBD)

Acronym: OPAL

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jan 16, 2008
Registry last updated
Dec 16, 2019

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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