Assessment of Efficacy and Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation

Summary

The purpose of this study is to evaluate the effect and safety of NKTR-118 treatment of opioid-induced constipation in patients with non-cancer-related pain, including those patients that have inadequate response to laxative therapy (LIR).

Timeline

Start

2011-03

Primary completion

2012-08

Completion

2012-08

Outcome

Met primary endpoint

registry analysis (superiority or other test); NKTR-118 12.5 mg vs Placebo; p = 0.015; Risk Ratio (RR) 1.380 (95% CI 1.062 to 1.795); Cochran-Mantel-Haenszel NCT01309841 ↗

registry analysis (superiority or other test); NKTR-118 25 mg vs Placebo; p = 0.001; Risk Ratio (RR) 1.509 (95% CI 1.168 to 1.949); Cochran-Mantel-Haenszel NCT01309841 ↗

Publications

• Webster L, Tummala R, Diva U, Lappalainen J. A 12-week extension study to assess the safety and tolerability of naloxegol in patients with noncancer pain and opioid-induced constipation. J Opioid Manag. 2016 Nov/Dec;12(6):405-419. doi: 10.5055/jom.2016.0360.
• Lawson R, King F, Marsh K, Altincatal A, Cimen A. Impact of Treatment with Naloxegol for Opioid-Induced Constipation on Patients' Health State Utility. Adv Ther. 2016 Aug;33(8):1331-46. doi: 10.1007/s12325-016-0365-y. Epub 2016 Jun 24.
• Tack J, Lappalainen J, Diva U, Tummala R, Sostek M. Efficacy and safety of naloxegol in patients with opioid-induced constipation and laxative-inadequate response. United European Gastroenterol J. 2015 Oct;3(5):471-80. doi: 10.1177/2050640615604543.
• Chey WD, Webster L, Sostek M, Lappalainen J, Barker PN, Tack J. Naloxegol for opioid-induced constipation in patients with noncancer pain. N Engl J Med. 2014 Jun 19;370(25):2387-96. doi: 10.1056/NEJMoa1310246. Epub 2014 Jun 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Naloxegol	Unknown	12.5 mg	Oral
Subject	Naloxegol	Unknown	25 mg	Oral

Indications