Naloxegol in Cancer Opioid-Induced Constipation
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|ClinicalTrials.gov Identifier: NCT02745353|
Recruitment Status : Recruiting
First Posted : April 20, 2016
Last Update Posted : March 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Constipation||Drug: naloxegol||Phase 2|
Opioid-induced constipation (OIC) is a common symptom in patients with cancer-related pain and requires burdensome self-titration of laxatives for prophylaxis and treatment. Consequently, naloxegol may have an important role in this setting. Naloxegol has been evaluated in relieving OIC with cancer patients in a randomized, double blind, placebo-controlled trial over 4 weeks with a 12-week extension phase. However, accrual was challenging and the trial was closed early. Given the complexity of cancer and its treatment, a key first step is to determine if evaluating naloxegol versus standard of care is feasible in the management of OIC in this setting.
Subjects will receive naloxegol 25mg daily or usual care for a 2-week initial treatment period followed by 3-day washout period, then a 2-week crossover treatment period where subjects will receive naloxegol or usual care. Treatment assignment during the initial and crossover treatment periods will be dictated by the randomization arm. Subjects will also have the option to participate in a 12-week extension phase of naloxegol.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Randomized, Single Center, Pilot Feasibility Study to Evaluate Naloxegol for Opioid-Induced Constipation in Cancer Patients|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2021|
Active Comparator: A
Patients in Arm A will receive a single daily dose of 25mg naloxegol for the 2-week initial treatment period, followed by a 3-day washout period and 2-week crossover treatment period in which the patient will receive the treating physician's usual care for OIC using a stimulant laxative + rescue medication.
Other Name: MOVANTIK
Active Comparator: B
Patients in Arm B will receive the treating physician's usual care for OIC using a stimulant laxative + rescue medication for the 2-week initial treatment period, followed by a 3-day washout period and 2-week crossover period in which the patient will receive a single daily dose of 25mg naloxegol.
Other Name: MOVANTIK
- feasibility [ Time Frame: 4 weeks ]completion of all study drugs
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02745353
|Contact: Chelsea Hagmannfirstname.lastname@example.org|
|United States, California|
|UCSD Moores Cancer Center||Recruiting|
|La Jolla, California, United States, 92093|
|Principal Investigator:||Eric Roeland, MD||University of California, San Diego|