NKTR-118 vs Placebo Relieving OIC in Patients with cancer-related pain

• Research type

  Research Study

• Full title

  A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NKTR-118 in Relieving Opioid-Induced Constipation (OIC) in Patients with Cancer-Related Pain

• IRAS ID

  82655

• Contact name

  Alison Franks

• Sponsor organisation

  AstraZeneca

• Eudract number

  2011-001985-16

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Phase III multi-center, double-blind, randomized, placebo-controlled, parallel group study to evaluate efficacy and safety of 2 doses of NKTR-118 (study medication) and placebo (dummy medication) in treating Opiod Induced Constipation in patients with cancer pain related. Opioid painkillers, such as codeine, morphine or oxycodone cause constipation by slowing down the bowels. NKTR-118 is being tested to determine if it allows the bowels to move on a regular schedule. Based on current knowledge, it is thought that NKTR-118 does not prevent the pain relief effect of opioid painkillers and does not cause withdrawal symptoms from such drugs. Approximately 672 patients (= 18 years old) will be enrolled in the study (to have 336 randomized) at sites in North America, Europe, South Africa and Australia over 12 months. Eligible patients will be randomized to receive NKTR-118 12.5 mg, NKTR-118 25 mg or matching placebo in a 1:1:1 ratio. The randomization scheme will be stratified by concurrent chemotherapy treatment (yes/no). The study duration will be up to approximately 10 weeks consisting of: - initial screening period of up to 14 days - 2-week OIC confirmation period (confirm the diagnosis of OIC and stability of the opioid regimen) - 4-week treatment period - follow-up visit 2 weeks after last dose of study drug Two bottles of study drug will be dispensed at Visit 3 (randomization), each bottle containing 35 tablets. Patients will take 2 tablets (1 from each bottle) once a day 1 hour before eating in the morning during the 4-week treatment period (Days 1 to 28). Electronic Diaries will be used by patients to collect information regarding Bowel Movements (BMs), degree of straining, stool consistency (BSS), complete/incomplete evacuation, pain level (NRS), use of bisacodyl laxative (rescue medication) and opioid medication for breakthrough pain. This study will use an external Data Safety Monitoring Board (DSMB) to monitor patient safety.

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  11/YH/0405

• Date of REC Opinion

  18 Jan 2012

• REC opinion

  Further Information Favourable Opinion