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Completed

NCT Number: NCT00620061

Opioid-induced Bowel Dysfunction: Long-Term Assessment of Lubiprostone

The purpose of this study is to evaluate the long-term safety and efficacy of lubiprostone administration in participants 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 Centre Pain Clinic, Winnipeg, Manitoba, Canada

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Has completed 12 weeks of blinded treatment in NCT00595946 or NCT00597428
  • Will continue to be treated consistently for chronic, non-cancer-related pain with any full agonist opiate and will continue opiate therapy for the duration of the study
  • Willing to continue to abstain from use of disallowed medications as defined per protocol

Exclusion criteria

  • Has newly diagnosed impaired renal function identified at the Screening Visit [i.e., serum creatinine concentration > 1.8 milligrams per deciliter (mg/dL)]
  • Has experienced an unexplained and/or clinically significant weight loss defined as > 5% within 90 days prior to Screening Visit.
  • Has plans to participate in another trial with an investigational drug or device during the course of the extension study

Treatment and study plan

Lubiprostone 24

Drug

24 mcg capsules for oral administration

Other names: Amitiza

Primary outcomes

  1. Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month

    Time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9

    A Spontaneous Bowel Movement (SBM) is defined as any bowel movement (BM) that did not occur within the 24-hour period following use of a rescue medication.

  2. Mean Weekly Bowel Movements (BMs) Per Month

    Time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9

    A Bowel Movement (BM) is defined as any BM (whether spontaneous or not)

Secondary outcomes

  1. Number of Participants Classified as Monthly Responders

    Time frame: Months 1, 2, 3, 4, 5, 6, 7, 8, and 9

    A weekly SBM frequency rate is calculated as (168 x Number of SBMs / Number of hours observed).

    A participant with an SBM frequency rate between 3 and 4 was considered a moderate responder. A subject with an SBM frequency rate higher than 4 was considered a full responder. If a subject was a moderate responder or full responder for at least half the weeks in a month, then he or she was considered a monthly responder.

  2. Straining Associated With Spontaneous Bowel Movements by Month

    Time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9

    Participants rate the straining associated with the SBM on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe The highest score is 4, and lower scores are better.

  3. Stool Consistency of Spontaneous Bowel Movements by Month

    Time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9

    Participants rate each spontaneous bowel movement on a scale where 0 = very loose, 1 = loose, 2 = normal, 3 = hard, 4 = very hard (little balls) The highest score is 4, but the best score is 2.

  4. Constipation Severity by Month

    Time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9

    Participants rate the severity of their constipation on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.

    The highest score is 4, but the best score is 0.

  5. Abdominal Bloating by Month

    Time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9

    Participants rate their bloating on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.

    The highest score is 4, but the best score is 0.

  6. Abdominal Discomfort by Month

    Time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9

    Participants rate their abdominal discomfort on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.

    The highest score is 4, but the best score is 0.

  7. Bowel Habit Regularity by Month

    Time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9

    Participants rate their bowel habit regularity on a balanced scale of 1 to 7 where 1=Very Regular and 7=Very Irregular.

    The highest score is 7, but the best score is 1.

  8. Treatment Effectiveness by Month

    Time frame: Months 1, 2, 3, 4, 5, 6, 7, 8, and 9

    Participants rate treatment effectiveness on a scale where 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, 4 = extremely effective.

    The highest and best score is 4.

  9. Mean Weekly Complete SBMs by Month

    Time frame: Months 1, 2, 3, 4, 5, 6, 7, 8, and 9

    Participants rate each SBM as complete if their bowels feel completely empty after the SBM

  10. Mean Weekly Complete BMs by Month

    Time frame: Months 1, 2, 3, 4, 5, 6, 7, 8, and 9

    Participants rate each BM as complete if their bowels feel completely empty after the BM

Sponsors and collaborators

Lead sponsor

Sucampo Pharma Americas, LLC

Industry

Registry information

Official study title

A Multi-center, Open-labeled Study of the Long-term Safety and Efficacy of Lubiprostone in Patients With Opioid-induced Bowel Dysfunction

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Feb 21, 2008
Registry last updated
Jan 21, 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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