Evaluation of the Quality of Life of Patients With Opioid... | NCT04173858

Studies
Evaluation of the Quality of Life of Patients With Opioid-induced Constipation Under Treatment With Naloxegol

NCT04173858

Sponsor

Kyowa Kirin Farmacéutica S.L.U.

Status

Completed

Last Update Posted

Nov 22, 2019Actual

Enrollment

126Actual

Phase

Not provided

Conditions

Opioid-induced Constipation

Interventions

Naloxegol

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 21, 2017Actual

Primary Completion Date

Oct 31, 2019Actual

Completion Date

Oct 31, 2019Actual

First Submitted Date

Nov 18, 2019

First Submission Date that Met QC Criteria

Nov 21, 2019

First Posted Date

Nov 22, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 21, 2019

Last Update Posted Date

Nov 22, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

126Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental		Patients with confirmed opioid-induced constipation diagnosis and inadequate response to laxatives.	Drug: Naloxegol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Naloxegol	Drug	25 mg oral naloxegol once daily.	Experimental

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assessment of Quality of Life	Patient Assessment of Constipation Quality of Life (PAC-QoL) Questionnaire	12 months

Secondary Outcomes

Measure	Description	Time Frame
Assessment of Constipation Symptoms	Patient Assessment of Constipation Symptoms (PAC-SYM) Questionnaire	15 days
Assessment of Constipation Symptoms	Patient Assessment of Constipation Symptoms (PAC-SYM) Questionnaire

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Ambulatory oncology patients in Spain with diagnosis of OIC.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Universitario de Torrejon		Torrejón de Ardoz	Madrid	28850	Spain

Condition Browse Module

MeSH Terms

ID	Term
D000079689	Opioid-Induced Constipation

Ancestor Terms

ID	Term
D003248	Constipation
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000589308	naloxegol

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided