Prolonged Release Naloxone HCl Dose Escalation Study in OIC Patients

• Research type

  Research Study

• Full title

  Randomised, double-blind, placebo-controlled, parallel-group design, multi-centre, dose-escalation phase III trial to investigate the efficacy, safety and tolerability of Naloxone HCl PR tablets administered in a dose range of 6 mg to 48 mg once daily in patients with opioid induced constipation

• IRAS ID

  124232

• Contact name

  mblagden

• Sponsor organisation

  Develco Pharma Schweiz AG

• Eudract number

  2012-004311-31

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• Research summary

  Opioid medications are often used for the management of pain and pain relief, in accordance with recommended clinical guidelines. However a common side effect of these medications is persistent moderate to severe constipation (so called opioid induced constipation or OIC). OIC is a major reason for stopping or switching opioid therapy and can lead to high healthcare costs for these patients. Naloxone is a well characterised and approved (marketed) product, which has a good demonstrated safety profile. It has recently been shown that Naloxone can block the effect of opioids in the gut to reduce OIC (when taken orally). At present there is no oral formulation of naloxone alone that exists for OIC. This study therefore intends to investigate the efficacy, safety and tolerability of prolonged release (PR) Naloxone tablets in OIC patients when taken once daily. In this study Naloxone PR will be tested together with a once daily regimen of oxycodone or hydromorphone HCl PR tablets XL (opioids). The study itself will consist of six phases: (1) screening phase, (2) titration phase, (3) run-in phase, (4) treatment phase, (5) extension phase and (6) follow-up phase, which are discussed in greater detail later. The study design has been extensively discussed and agreed with the German Regulatory Agency (BfArM). This study design is very similar to another study for which Naloxone was administered twice daily. The study design involving the twice daily administration of Naloxone was discussed and agreed with the MHRA.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  13/EE/0051

• Date of REC Opinion

  19 Mar 2013

• REC opinion

  Further Information Favourable Opinion