NCT01167127

An Open Study to Observe OXN Treatment for Patients With Moderate to Severe Non-malignant Pain

Completed Phase 3 Last updated 11 February 2013

What this trial tests

Phase 3 trial testing Oxycodone hydrochloride and naloxone hydrochloride combination, prolonged release in Pain in 113 participants. Completed in 1 April 2011.

Timeline

1 June 2009

Primary endpoint
1 April 2011

1 April 2011

Quick facts

Lead sponsor	Mundipharma Pharmaceuticals B.V.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	113
Start date	1 June 2009
Primary completion	1 April 2011
Estimated completion	1 April 2011
Sites	1 location across Netherlands

Drugs / interventions tested

• Oxycodone hydrochloride and naloxone hydrochloride combination, prolonged release — full drug profile →

Conditions studied

• Pain — all drugs for Pain →

Sponsor

Mundipharma Pharmaceuticals B.V. — full company profile →

Who can join

18 and older, any sex, with Pain. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Pain Relief
  The Pain relief (NAS, 0-100) and the Bowel Function Index (BFI), 3 questions, both at week 1-4 of the core study

Sponsor's own description

The main objective of the study is to observe the OXN treatment of patients with moderate to severe non-malignant pain in daily clinical practise with respect to pain relief and bowel function. Patients who have insufficient pain relief and/or unacceptable side effects with the previous analgesic treatment WHO step 1 or 2 and require around-the-clock opioid therapy can be included in the study.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Personalized medicine for pathological circadian dysfunctions.
   Skelton RL, Kornhauser JM, Tate BA. · · 2015 · cited 5× · PMID 26150790 · DOI 10.3389/fphar.2015.00125