The purpose of this study is to evaluate the long-term safety and tolerability of NKTR-118 treatment of opioid-induced constipation (OIC) in patients with non-cancer-related pain.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
844
25 mg oral tablet once daily
As prescribed by the investigator
Incidence of Patients Experiencing at Least One Adverse Event (AE)
The incidence of patients experiencing at least one AE during the randomized treatment and follow-up periods was calculated.
Time frame: Baseline (Week 0) to end of the follow-up period
Incidence of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP)
The incidence of patients experiencing AEs that resulted in discontinuation of IP during the randomized treatment or follow-up periods was calculated.
Time frame: Baseline (Week 0) to end of the follow-up period
Incidence of Patients Experiencing Severe Adverse Events (SAEs)
The incidence of patients experiencing SAEs during the randomized treatment and follow-up periods was calculated.
Time frame: Baseline (Week 0) to end of the follow-up period
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Research Site
Athens, Alabama, United States
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Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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Mobile, Alabama, United States
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Pell City, Alabama, United States
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Garden Grove, Arizona, United States
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Goodyear, Arizona, United States
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Mesa, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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