Evaluation of the Quality of Life of Patients With Opioid-induced Constipation Under Treatment With Naloxegol
KYONAL
1 other identifier
observational
126
1 country
1
Brief Summary
Opioid-induced constipation (OIC) is a common feature in patients treated with strong opioids. Such medication is often prescribed together with a laxative (osmotic, emollient), with effectiveness depending on the individual patient. Peripherally-acting, mu-opioid receptor antagonists (PAMORAs), such as Naloxegol, have proven to be effective against OIC in patients with inadequate response to laxatives without reducing opioid analgesic effect. However, evidence regarding efficacy and safety on patients with cancer is still scarce. The objective of this study was to analyze the efficacy of naloxegol in a real-world setting by assessing Quality of Life outcomes, and to obtain data on its safety in the long term in patients with cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2019
CompletedFirst Submitted
Initial submission to the registry
November 18, 2019
CompletedFirst Posted
Study publicly available on registry
November 22, 2019
CompletedNovember 22, 2019
November 1, 2019
2.1 years
November 18, 2019
November 21, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of Quality of Life
Patient Assessment of Constipation Quality of Life (PAC-QoL) Questionnaire
12 months
Secondary Outcomes (4)
Assessment of Constipation Symptoms
15 days
Assessment of Constipation Symptoms
1 month
Assessment of Constipation Symptoms
3 months
Assessment of Constipation Symptoms
6 months
Study Arms (1)
Experimental
Patients with confirmed opioid-induced constipation diagnosis and inadequate response to laxatives.
Interventions
Eligibility Criteria
Ambulatory oncology patients in Spain with diagnosis of OIC.
You may qualify if:
- Diagnosis of Cancer
- Treatment with opioids
- OIC symptoms
- Inadequate response to laxatives
- Karnofsky equal or above 50
- Ambulatory
- Must be able to complete questionnaire forms
You may not qualify if:
- Hypersensitivity to Naloxegol or vehicle
- Suspicion or high risk of gastrointestinal block
- High risk of GI perforation
- Severe liver failure
- Pregnancy or breastfeeding
- Use of potent CYP3A4 inhibitors
- Cognitive impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Universitario de Torrejon
Torrejón de Ardoz, Madrid, 28850, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2019
First Posted
November 22, 2019
Study Start
September 21, 2017
Primary Completion
October 31, 2019
Study Completion
October 31, 2019
Last Updated
November 22, 2019
Record last verified: 2019-11