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

Inclusion 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.