Assessment of Efficacy and Safety 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

NCT01323790

D3820C00005

2011-001986-41 (EudraCT Number)

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, including those patients that have inadequate response to laxative therapy (LIR).

Enrollment: 700 patients

Sex: All

Ages: 18 to 84 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provision of written informed consent prior to any study-specific procedures.
• Self-reported active symptoms of OIC at screening (<3 SBMs/week and experiencing ≥1 reported symptom of hard/lumpy stools, straining, or sensation of incomplete evacuation/anorectal obstruction in at least 25% of BMs over the previous 4 weeks); and Documented confirmed OIC (<3 SBMs/week on average over the 2-week OIC confirmation period.
• Receiving 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 for a minimum of 4 weeks prior to screening for non-cancer-related pain with no anticipated change in opioid dose requirement over the proposed study period as a result of disease progression.
• Willingness to stop all laxatives and other bowel regimens including prune juice and herbal products throughout the 2-week OIC confirmation period and the 12-week treatment period, and to use only bisacodyl as rescue medication if a 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 first study visit 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 to the gastrointestinal tract that could impose a risk to the patient.
• Pregnancy or lactation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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700 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

Oral treatment

Treatment:

Drug: NKTR-118

Drug: NKTR-118

2

Experimental group

Description:

Oral treatment

Treatment:

Drug: NKTR-118

Drug: NKTR-118

3

Placebo Comparator group

Description:

Oral treatment

Treatment:

Drug: Placebo