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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Opioid-Induced Constipation (OIC)

Treatments: Drug: Placebo; Drug: NKTR-118

Study type: Interventional

Funder types: Industry

Identifiers

NCT01395524

D3820C00007

Details and patient eligibility

About

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.

Enrollment: 302 patients

Sex: All

Ages: 18 to 84 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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302 participants in 3 patient groups, including a placebo group

NKTR-118 12.5mg

Experimental group

Treatment:

Drug: NKTR-118

Drug: NKTR-118

NKTR-118 25mg

Experimental group

Treatment:

Drug: NKTR-118

Drug: NKTR-118

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo