Opioid-induced Constipation
Conditions
Keywords
Naloxegol, PAMORA
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.
Interventions
DRUGNaloxegol
25 mg oral naloxegol once daily.
Sponsors
Kyowa Kirin Farmacéutica S.L.U.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
at the start of the study: * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Quality of Life | 12 months | Patient Assessment of Constipation Quality of Life (PAC-QoL) Questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Constipation Symptoms | 15 days | Patient Assessment of Constipation Symptoms (PAC-SYM) Questionnaire |
Countries
Spain
Outcome results
None listed