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A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NKTR-118 in Patients With Non-Cancer-Related Pain and Opioid-Induced Constipation (OIC)

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Trial Profile

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NKTR-118 in Patients With Non-Cancer-Related Pain and Opioid-Induced Constipation (OIC)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 22 Dec 2022

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At a glance

  • Drugs Naloxegol (Primary)
  • Indications Constipation
  • Focus Registrational; Therapeutic Use
  • Acronyms KODIAC-05
  • Sponsors AstraZeneca

Most Recent Events

  • 26 Oct 2022 Results of pooled analysis from KODIAC 4/5; NCT01309841/NCT01323790 studies, (n=1337) assessing the efficacy of naloxegol in providing clinically meaningful HR-QOL improvement utilizing the patient assessment of constipation quality of life questionnaire (PAC-QOL) in patients with opioid-induced constipation, presented at the American College of Gastroenterology Annual Scientific Meeting and Postgraduate Course 2022.
  • 26 Oct 2022 Results of a pooled analysis assessing symptom improvement utilizing patient assessment of constipation symptoms questionnaire (PAC-SYM) from two randomized, placebo-controlled trials (KODIAC-04 and KODIAC-05) presented at the American College of Gastroenterology Annual Scientific Meeting and Postgraduate Course 2022
  • 27 Oct 2021 Results from pooled analysis of two trials (KODIAC 4 and 5) assessing initial onset and maintenance of response in subjects with extreme OIC at baseline presented at the American College of Gastroenterology Annual Scientific Meeting and Postgraduate Course 2021

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