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Naloxegol in Cancer Opioid-Induced Constipation

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ClinicalTrials.gov Identifier: NCT02745353
Recruitment Status : Terminated (Couldn't enough accrue patients)
First Posted : April 20, 2016
Results First Posted : September 4, 2019
Last Update Posted : December 9, 2019
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Joseph Ma, University of California, San Diego

Tracking Information
First Submitted Date  ICMJE April 15, 2016
First Posted Date  ICMJE April 20, 2016
Results First Submitted Date  ICMJE April 19, 2019
Results First Posted Date  ICMJE September 4, 2019
Last Update Posted Date December 9, 2019
Actual Study Start Date  ICMJE May 2016
Actual Primary Completion Date June 22, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2019)
Number of Participants That Completed Naloxegol 25mg and the Number of Participants That Completed Standard of Care [ Time Frame: 4 weeks ]
completion of treatment defined as participants receiving all single daily doses for 2 weeks
Original Primary Outcome Measures  ICMJE
 (submitted: April 15, 2016)
feasibility [ Time Frame: 4 weeks ]
completion of all study drugs
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Naloxegol in Cancer Opioid-Induced Constipation
Official Title  ICMJE A Phase II, Randomized, Single Center, Pilot Feasibility Study to Evaluate Naloxegol for Opioid-Induced Constipation in Cancer Patients
Brief Summary The purpose of this study is to compare the effect of naloxegol versus the patient's usual care in treating opioid-induced constipation, as well as the effect on the patient's quality of life and how much pain is experienced. Also, the purpose of this study is to compare whether treatment with naloxegol versus usual care has any impact on the number of hospital or clinic visits or telephone calls to the patient's physician that are related to constipation, and to determine the patient's preference for continuing to receive naloxegol as treatment for opioid-induced constipation.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Constipation
Intervention  ICMJE Drug: naloxegol
Other Name: MOVANTIK
Study Arms  ICMJE
  • 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.
    Intervention: Drug: naloxegol
  • 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.
    Intervention: Drug: naloxegol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 30, 2019)
7
Original Estimated Enrollment  ICMJE
 (submitted: April 15, 2016)
60
Actual Study Completion Date  ICMJE June 22, 2017
Actual Primary Completion Date June 22, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adults greater than or equal to 18 years old.
  • Eastern Cooperative Oncology Group (ECOG) less than or equal to 3.
  • Glomerular filtration rate (GFR) greater than or equal to 30 ml/min/1.73m2 by Modification of Diet in Renal Disease (MDRD).
  • Corrected serum calcium level less than or equal to 10.5 mg/dL.
  • Estimated life expectancy greater than or equal to 6 months.
  • Negative pregnancy test prior to initiating study treatment for females of childbearing potential.

Exclusion Criteria:

  • Patients receiving the following medications within 3 days of Study Day 1 and/or are planned to receive throughout the duration of the study period: opioid antagonist, mixed antagonist, a strong CYP3A4 and/or P-glycoprotein (P-gp) inhibitor, a moderate CYP3A4 and/or P-gp inhibitor, and/or a strong CYP3A4 inducer.
  • Concurrent total parenteral nutrition and/or use of metoclopramide.
  • Patients at high risk for bowel perforation.
  • Constipation that was not primarily caused by opioids in the investigator's medical opinion.
  • A condition that may have affected the permeability of the blood-brain barrier (e.g., known brain metastases, meningeal metastases, brain injury, multiple sclerosis, recent brain injury, uncontrolled epilepsy)
  • Patient has clinically active diverticular disease.
  • Past medical history of irritable bowel syndrome, signs of active gastrointestinal (GI) bleeding, acute surgical abdomen, bowel stents, indwelling peritoneal catheter, mechanical GI obstruction, fecal impaction, or fecal ostomy.
  • Patient has motility/neurologic disorders including autonomic failure (spinal cord lesions, tumor invasion of nerves) and/or poorly controlled endocrine/metabolic disorders (hypercalcemia, hypokalemia, diabetes, hypothyroidism), as determined by the investigator.
  • Uncontrolled cancer pain despite analgesic therapy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02745353
Other Study ID Numbers  ICMJE 160121
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Joseph Ma, University of California, San Diego
Study Sponsor  ICMJE Joseph Ma
Collaborators  ICMJE AstraZeneca
Investigators  ICMJE
Principal Investigator: Joseph Ma, PharmD UCSD
PRS Account University of California, San Diego
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP