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A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Multiple-Dose, Dose Escalation Study to Evaluate the Efficacy, Safety and Tolerability of NKTR-118 in Patients with Opioid-Induced Constipation...

Update Il y a 4 ans
Reference: EUCTR2007-005421-30

A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Multiple-Dose, Dose Escalation Study to Evaluate the Efficacy, Safety and Tolerability of NKTR-118 in Patients with Opioid-Induced Constipation (OIC)

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Extract

Objectives: Primary Objective: To evaluate the efficacy of NKTR-118 at various dose levels, with efficacy defined as the change in the number of spontaneous bowel movements (SBMs) per week from baseline. The primary endpoint is the change from baseline in SBMs/week averaged throughout the treatment period, defined as SBMs/week for the overall treatment period minus baseline SBMs/week.

Inclusion criteria

  • Opioid induced constipation

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