Targin for Non-cancer Pain

NCT01918098 ↗

Phase 3 Completed 230 enrolled Mundipharma (China) Pharmaceutical Co. Ltd

RandomizedParallel-groupDouble-blindTreatment

Summary

To determine the improvement in symptoms of constipation in subjects receiving treatment with oxycodone/naloxone prolonged release tablets (OXN) compared to oxycodone prolonged release tablets (OXY) based on the Bowel Function Index (BFI)

Timeline

Start: 2013-09-01
Primary completion: 2017-03-30
Completion: 2017-03-30

Outcome

Met primary endpoint

paper at week 8 improvements were greater with OXN PR vs OXY PR (least squares mean [LSM] difference (95% CI) - 9.1 (- 14.0, - 4.2); P < 0.001. PMID 32020565 ↗

Publications

Leng X, Zhang F, Yao S, Weng X, Lu K, Chen G, Huang M, Huang Y, Zeng X, Hopp M, Lu G. Prolonged-Release (PR) Oxycodone/Naloxone Improves Bowel Function Compared with Oxycodone PR and Provides Effective Analgesia in Chinese Patients with Non-malignant Pain: A Randomized, Double-Blind Trial. Adv Ther. 2020 Mar;37(3):1188-1202. doi: 10.1007/s12325-020-01244-x. Epub 2020 Feb 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Naloxone	Small molecule	2.5 mg	—
Subject	Naloxone	Small molecule	5 mg	—
Subject	Naloxone	Small molecule	10 mg	—
Subject	Oxycodone	Other / unclassified	5 mg	—
Subject	Oxycodone	Other / unclassified	10 mg	—
Subject	Oxycodone	Other / unclassified	20 mg	—

Indications

No indication recorded.