NKTR-118 vs Placebo in Patients with Non-Cancer-Related Pain & OIC
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NKTR-118 in Patients with Non-Cancer-Related Pain and Opioid-Induced Constipation (OIC)
IRAS ID
92908
Contact name
Mark Peter Rockett
Sponsor organisation
AstraZeneca AB
Eudract number
2011-001986-41
Clinicaltrials.gov Identifier
Research summary
This is a Phase III, double-blind, randomized, placebo-controlled, parallel group study to evaluate the efficacy and safety of NKTR-118 (study drug) 12.5 mg and 25 mg in the treatment of opioid induced constipation (OIC) in patients with non-cancer-related pain.Approximately 630 patients aged 18 to 84, in about 120 sites globally, will take part in the study for up to 18 weeks (screening up to 2 weeks, OIC confirmation 2 weeks, treatment up to 12 weeks and a follow-up visit 2 weeks after last dose of NKTR-118) Patients with confirmed OIC and stable maintenance opioid regimen will be randomized to take either: - NKTR-118 12.5 mg once daily - NKTR-118 25 mg once daily - placebo once daily Patients will be asked to stop all their constipation relief aids and provided with a rescue medication instead (bisacodyl), complete an electronic Diary daily (recording things like date and time of spontaneous bowel movement or lack of it, use of bisacodyl, stool consistency, pain level), undergo various assessment such as: - emotional state (Columbia-Suicide Severity Rating Scale) - quality of life (EuroQoL-5D questionnaire) - constipation (Patient Assessment of Constipation Quality of Life; Patient Assessment of Constipation Symptoms; laxative response) - opioid withdrawal symptoms (Modified Himmelsbach Scale) Patients will be required to provide blood and urine samples, have their vital signs and ECG taken throughout the whole duration of the study to assess their eligibility (e.g. screening)and the efficacy and safety of drug (from visit 3 till end of study). Potential patients, at screening, will be assessed for being at risk of colorectal cancer as well to rule out underlying colorectal malignancy as possible contributor to constipation and avoid enrolling patients with underlying malignancy into prolonged clinical trials.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
11/LO/1950
Date of REC Opinion
21 Feb 2012
REC opinion
Further Information Favourable Opinion