CompletedPhase 3

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

United States, Canada439 participantsStarted 2007-12

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month

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

Mean Weekly Bowel Movements (BMs) Per Month

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

Trial details

NCT IDNCT00620061

SponsorSucampo Pharma Americas, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-09

Results submitted2016-07-12

View on ClinicalTrials.gov More Opioid-Induced Bowel Dysfunction trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.