Who is sponsoring NCT00412100?

NCT00412100 is sponsored by Mundipharma Research GmbH & Co KG.

What drugs are being tested in NCT00412100?

Interventions in NCT00412100: Oxycodone naloxone prolonged release tablets (OXN).

Is NCT00412100 still recruiting?

NCT00412100 is currently completed. Last updated 19 October 2018.

Last reviewed 2018-10-19 · How we verify

NCT00412100

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Randomsied, Double-blind, Double-dummy, Parallel-group Multicentre Study to Demonstrate Improvement in Symptoms of Constipation in Subjects With Non-malignant Pain Taking Oxycodone Equivalent of 60-80 mg/Day as Oxycodone/Naloxone Prolonged Release Compared to Subjects Taking Oxycodone Prolonged Release Tablets Alone

Completed Phase 3 Last updated 19 October 2018

What this trial tests

Phase 3 trial testing Oxycodone naloxone prolonged release tablets (OXN) in Pain. Completed in 1 September 2008.

Timeline

1 April 2006

Primary endpoint
1 July 2008

1 September 2008

Quick facts

Lead sponsor	Mundipharma Research GmbH & Co KG
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Start date	1 April 2006
Primary completion	1 July 2008
Estimated completion	1 September 2008

Drugs / interventions tested

Oxycodone naloxone prolonged release tablets (OXN) — full drug profile →

Conditions studied

Pain — all drugs for Pain →

Sponsor

Mundipharma Research GmbH & Co KG — 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.

To demonstrate that subjects with moderate to severe non malignant pain taking oxycodone/naloxone prolonged release tablets have improvement in symptoms of constipation compared to subjects taking oxycodone prolonged release tablets alone.
Time frame: 12 weeks with a 6 month open label extension

Sponsor's own description

The primary objective is to demonstrate that patients taking oxycodone/naloxone prolonged release tablets have improvement in symptoms of constipation compared to subjects taking oxycodone prolonged release tablets alone.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Efficacy and safety of combined prolonged-release oxycodone and naloxone in the management of moderate/severe chronic non-malignant pain: results of a prospectively designed pooled analysis of two randomised, double-blind clinical trials.
Löwenstein O, Leyendecker P, Lux EA, Blagden M, et al · · 2010 · cited 57× · PMID 20920236 · DOI 10.1186/1472-6904-10-12
Oxycodone/Naloxone: role in chronic pain management, opioid-induced constipation, and abuse deterrence.
DePriest AZ, Miller K. · · 2014 · cited 23× · PMID 25135384 · DOI 10.1007/s40122-014-0026-2

Verify or expand the search:

Other recruiting trials for Pain

Currently open trials in the same condition.

NCT07533409 — Tactile and Pain Sensory Thresholds and Hand Grip Strength · recruiting
NCT07294092 — Ketamine and Propofol NeuroImaging · EARLY_PHASE1 · recruiting
NCT07290205 — Remimazolam NeuroImaging · EARLY_PHASE1 · recruiting
NCT07487610 — Relationship Between Neuropathic Pain and Geriatric Assessment Parameters in Patients Aged 80 Years and Older · recruiting
NCT07454993 — The Effect of Music During Colonoscopy · NA · recruiting

Other Mundipharma Research GmbH & Co KG trials

Trials by the same sponsor.

NCT03062644 — Efficacy and Safety in a Randomised Acute Pain Study of MR308: STARDOM2. · Phase 3 · completed
NCT02982161 — Efficacy and Safety in a Randomised Acute Pain Study of MR308 (Tramadol/Celecoxib). · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00412100 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Mundipharma Research GmbH & Co KG
Last refreshed: 19 October 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00412100.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing