NAXOS
Research type
Research Study
Full title
Randomised, double-blind, placebo-controlled, parallel-group, multi-centre, phase III trial to investigate the efficacy, safety and tolerability of Naloxone HCl PR Tablets in patients with opioid induced constipation
IRAS ID
218482
Contact name
Karin Schmid
Contact email
Sponsor organisation
Develco Pharma Schweiz AG
Eudract number
2017-000657-39
Duration of Study in the UK
1 years, 10 months, 28 days
Research summary
This study is to find out whether Naloxone HCl Prolonged Release Tablets are effecive at treating patients currently suffering from opioid-induced constipation. The patients will be reviewed for their constipation symptoms before being given a treatment. The patient will either receive Naloxone HCl 24 mg total daily, Naloxone HCl 48mg total daily or a placebo. The patient will take the medication twice each day. They will take the treatment for a maximum of 12 weeks and during this time the patients will complete an e-diary to track their bowel movements and when they needed to take a laxative. During the study patients will be expected to have blood samples, but no other invasive assessments will be done. Once the 12 weeks have finished, the patients will have to stop the treatment and will have a final check.
REC name
North East - York Research Ethics Committee
REC reference
17/NE/0173
Date of REC Opinion
11 Jul 2017
REC opinion
Further Information Favourable Opinion