Assessment of Efficacy and Safety in Relieving Opioid-induced Constipation in Patients With Cancer-related Pain
Condition: Opioid-Induced Constipation
MeSH terms: Constipation; Opioid-Induced Constipation; Cancer Pain
Intervention: NKTR-118; NKTR-118; Placebo
Intervention description: 12.5 mg oral tablet once daily; 25 mg oral tablet once daily; Oral treatment
Intervention MeSH terms: Naloxegol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cancer-Related Pain; Opioid-Induced Constipation; OIC

Summary:

      The purpose of this study is to compare the effect of NKTR-118 with placebo in the treatment
      of opioid-induced constipation (OIC) in patients with cancer-related pain, including those
      patients that have inadequate response to laxative therapy (LIR).

      The study consists of 2 parts; A initial 4-week treatment period (part A) and then a 12 week
      extension with active treatment (part B).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of written informed consent prior to any study-specific procedures.

          -  Men and women aged 18 or older.

          -  Histologically or cytologically confirmed neoplasm causing pain and requiring
             management with opioids.

          -  Self-reported active symptoms of OIC at screening (<3 RFBMs/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 RFBMs/week on average aver the 2-week OIC
             confirmation period.

          -  Receiving a stable maintenance opioid regimen consisting of a total daily dose of >30
             mg of oral morphine, or equianalgesic amount(s) of 1 or more opioid therapies for a
             minimum of 4 weeks prior to screening for cancer-related pain with no anticipated
             change in opioid dose requirement over the proposed study period as a result of
             disease progression.

        Exclusion Criteria:

          -  Patients receiving Opioid regimen for treatment of pain other than related to cancer.

          -  Any condition that may have affected the permeability of the blood-brain barrier, eg,
             known brain metastases, meningeal metastases, brain injury, multiple sclerosis, recent
             brain injury, uncontrolled epilepsy.

          -  Patients with cancer-related pain due to ovarian cancer, leukaemia, or lymphoma are
             excluded. Patients with multiple myeloma will be allowed.

          -  Patients requiring radiation therapy between the diaphragm and pelvis 4 weeks prior to
             Visit 1 (screening) and/or during Part A of the study are excluded. Any patients with
             suspected clinically relevant radiation-induced injury of small or large intestine are
             excluded.

          -  Pregnancy or lactation.