A 12-week Extension of the Phase III Study (D3820C00004) to Assess the Effect and Safety of NKTR-118 in Patients With Non-cancer-related Pain and Opioid-induced Constipation

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effect and safety of NKTR-118 treatment of opioid-induced constipation in patients with non-cancer-related pain over a 6-month period.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Analgesics, Opioid; Naloxegol

Criteria

Inclusion Criteria:

• Must have completed the 12-week study D3820C00004 through Visit 8.

• Provision of written informed consent prior to any study-specific procedures.

• Men and women who were between the ages of >18 and <85 years at the time of the screening visit for study D3820C00004.

• Continuing to receive a stable maintenance opioid regimen consisting of a total daily dose of 30 mg to 1000 mg of oral morphine, or equianalgesic amount(s) of 1 or more other opioid therapies.

• Willingness to continue abstinence from all laxatives and other bowel regimens including prune juice and herbal products throughout this additional 12-week treatment period, and to use only bisacodyl as rescue medication if a bowel movement (BM) has not occurred within at least 72 hours of the last recorded BM.

Exclusion Criteria:

• Patients receiving opioid regimen for treatment of pain related to cancer.

• History of cancer within 5 years from the screening visit of study D3820C00004 with the exception of basal cell cancer and squamous cell skin cancer.

• Medical conditions and treatments associated with diarrhea, intermittent loose stools, or constipation.

• Other issues related to the gastrointestinal tract that could impose risk to the patient.

• Pregnancy or lactation.