Stopped: The study was stopped due to challenges recruiting eligible patients.
The purpose of this study is to determine if naloxegol can be used in the treatment of opioid-induced constipation in patients with cancer and pain. This phase 4 study consists of a two week randomized double blind period followed by a two week open-label period.
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Numerical Rating Scale (NRS) for Pain Change From Baseline
Timeframe: Assessed from screening/Opioid Induced Constipation (OIC) Confirmation period through study completion, approximately 6 weeks.
Daily Opioid Use Change From Baseline
Timeframe: Assessed from screening through study completion, approximately 6 weeks.
Adverse Events Associated With Blood Laboratory Result Changes From Baseline
Timeframe: Change from Baseline at End of Double Blind Phase (Visit 3, approximately day 15)
Electrocardiogram QTC Interval
Timeframe: Change from Baseline at End of Double Blind Phase (Visit 3, approximately day 15)
Electrocardiogram Heart Rate
Timeframe: Change from Baseline at End of Double Blind Phase (Visit 3, approximately day 15)
Change From Baseline in Systolic Blood Pressure
Timeframe: Change from Baseline in systolic blood pressure through study completion, approximately 6 weeks.
Change From Baseline in Diastolic Blood Pressure
Timeframe: Change from Baseline in diastolic blood pressure through study completion, approximately 6 weeks.
Change From Baseline in Respiratory Rate
Timeframe: Change from Baseline in respiratory rate through study completion, approximately 6 weeks.
Change From Baseline in Pulse Rate
Timeframe: Change from Baseline in pulse rate through study completion, approximately 6 weeks.