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

Phase 3CompletedNCT00620061

Sucampo Pharma Americas, LLC439 enrolled

Overview

The purpose of this study is to evaluate the long-term safety and efficacy of lubiprostone administration in participants with opioid-induced bowel dysfunction.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

439

Conditions

Opioid-Induced Bowel Dysfunction

Interventions

Lubiprostone 24DRUG

24 mcg capsules for oral administration

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (123)

Outcomes

Primary Outcomes

Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month

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.

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

Mean Weekly Bowel Movements (BMs) Per Month

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

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

Secondary Outcomes

Number of Participants Classified as Monthly Responders

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.

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

Straining Associated With Spontaneous Bowel Movements by Month

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.

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

Stool Consistency of Spontaneous Bowel Movements by Month

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.

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

Constipation Severity by Month

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

The Birmingham Pain Center

Birmingham, Alabama, United States

Simon Williamson Clinic, PC

Hueytown, Alabama, United States

Alabama Orthopedic Clinic

Mobile, Alabama, United States

Clinical Research Advantage, Inc./ Mesa Family Medical Center

Mesa, Arizona, United States

Redpoint Research

Phoenix, Arizona, United States

HOPE Research Institute

Phoenix, Arizona, United States

Clinical Research Advantage, Inc.

Phoenix, Arizona, United States

Clinical Research Advantage, Inc. / East Valley Family Physicians, PLC

Tempe, Arizona, United States

Clinical Research Advantage, Inc.

Tempe, Arizona, United States

Premiere Pharamaceutical Research, LLC

Tempe, Arizona, United States

...and 113 more locations

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.

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

Abdominal Bloating by Month

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.

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

Abdominal Discomfort by Month

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.

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

Bowel Habit Regularity by Month

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.

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

Treatment Effectiveness by Month

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.

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

Mean Weekly Complete SBMs by Month

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

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

Mean Weekly Complete BMs by Month

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

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