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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Constipation
Intervention Drug: naloxegol
Enrollment 7
Recruitment Details  
Pre-assignment Details  
Arm/Group Title A- Naloxegol/ Standard of Care B- Standard of Care/ Naloxegol
Hide Arm/Group Description

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.

naloxegol

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.

naloxegol

Period Title: First Intervention (2 Weeks)
Started 4 3
Completed 1 1
Not Completed 3 2
Period Title: Washout (3 Days)
Started 1 1
Completed 1 1
Not Completed 0 0
Period Title: Second Intervention (2 Weeks)
Started 1 1
Completed 1 0
Not Completed 0 1
Arm/Group Title A- Naloxegol/Standard of Care B - Standard of Care/Naloxegol Total
Hide Arm/Group Description

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.

naloxegol

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.

naloxegol

Total of all reporting groups
Overall Number of Baseline Participants 4 3 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 7 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
  75.0%
2
  66.7%
5
  71.4%
>=65 years
1
  25.0%
1
  33.3%
2
  28.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 7 participants
Female
2
  50.0%
1
  33.3%
3
  42.9%
Male
2
  50.0%
2
  66.7%
4
  57.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 7 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
4
 100.0%
3
 100.0%
7
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 3 participants 7 participants
4 3 7
1.Primary Outcome
Title Number of Participants That Completed Naloxegol 25mg and the Number of Participants That Completed Standard of Care
Hide Description completion of treatment defined as participants receiving all single daily doses for 2 weeks
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A (Naloxegol/Standard of Care) Arm B (Standard of Care/ Naloxego)
Hide Arm/Group Description:

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.

naloxegol

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.

naloxegol

Overall Number of Participants Analyzed 4 3
Measure Type: Count of Participants
Unit of Measure: Participants
Naloxegol
4
 100.0%
3
 100.0%
Standard of Care
1
  25.0%
1
  33.3%
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Naloxegol Standard of Care
Hide Arm/Group Description All patients who received a single daily dose of 25 mg Naloxegol during the entire study duration All patients who received Standard of Care during the entire study duration
All-Cause Mortality
Naloxegol Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   2/5 (40.00%)      0/4 (0.00%)    
Hide Serious Adverse Events
Naloxegol Standard of Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/5 (60.00%)      1/4 (25.00%)    
Blood and lymphatic system disorders     
Anemia   2/5 (40.00%)  2 0/4 (0.00%)  0
platelet count decreased   1/5 (20.00%)  1 0/4 (0.00%)  0
Immune system disorders     
Fever   1/5 (20.00%)  1 0/4 (0.00%)  0
Surgical and medical procedures     
Hospitalization   2/5 (40.00%)  3 1/4 (25.00%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Naloxegol Standard of Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/5 (60.00%)      2/4 (50.00%)    
Blood and lymphatic system disorders     
Hypoalbuminemia   1/5 (20.00%)  1 0/4 (0.00%)  0
Anemia   1/5 (20.00%)  2 1/4 (25.00%)  1
Hyperkalemia   0/5 (0.00%)  0 1/4 (25.00%)  1
General disorders     
Fever   1/5 (20.00%)  1 0/4 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Eric Roeland, MD
Organization: UCSD
Phone: (858) 534-7079
EMail: eroeland@ucsd.edu
Layout table for additonal information
Responsible Party: Joseph Ma, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02745353    
Other Study ID Numbers: 160121
First Submitted: April 15, 2016
First Posted: April 20, 2016
Results First Submitted: April 19, 2019
Results First Posted: September 4, 2019
Last Update Posted: December 9, 2019