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

Sucampo

Status and phase: Completed; Phase 3

Conditions: Opioid-Induced Bowel Dysfunction

Treatments: Drug: Lubiprostone 24

Study type: Interventional

Funder types: Industry

Identifiers

NCT00620061

OBD06S1

Details and patient eligibility

About

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

Enrollment: 439 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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439 participants in 1 patient group

All Participants

Experimental group

Description:

Lubiprostone: 24 mcg capsule twice daily (BID) for 36 weeks

Treatment:

Drug: Lubiprostone 24