Study identifier:D3820C00007
ClinicalTrials.gov identifier:NCT01395524
EudraCT identifier:N/A
CTIS identifier:N/A
A Randomized, Double-Blind, Placebo-Controlled 12-Week Extension Study to Assess the Safety and Tolerability of NKTR-118 in Patients with Non-Cancer-Related Pain and Opioid-Induced Constipation (OIC)
Opioid-Induced Constipation (OIC)
Phase 3
No
NKTR-118, Placebo
All
302
Interventional
18 Years - 84 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Jan 2017 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
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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 over a 6-month period.
Location
Location
ADELAIDE, SA, Australia
Location
ALBUQUERQUE, NM, United States
Location
ANAHEIM, CA, United States
Location
ATLANTA, GA, United States
Location
AUSTIN, TX, United States
Location
AVON, IN, United States
Location
BANSKA BYSTRICA, Slovakia
Location
BEAVERCREEK, OH, United States
Arms | Assigned Interventions |
---|---|
Experimental: NKTR-118 12.5mg | Drug: NKTR-118 12.5 mg oral tablet once daily |
Experimental: NKTR-118 25mg | Drug: NKTR-118 25 mg oral tablet once daily |
Placebo Comparator: Placebo | Drug: Placebo Oral tablet intake once daily |
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