A Post-Marketing Surveillance of the Abuse of Eluxadoline using Poison Centre Data in the United States and Canada

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/37043
• EU PAS number:
  EUPAS25247
• Study ID:
  37043
• Official title and acronym:
  A Post-Marketing Surveillance of the Abuse of Eluxadoline using Poison Centre Data in the United States and Canada
• DARWIN EU® study:
  No
• Study countries:
  Canada

  United States
• Study description:
  The primary objective is to quantify the rate of abuse and serious adverse events for eluxadoline during a 3-year post approval period
• Study status:
  Finalised

Study timelines

Date when funding contract was signed

Planned: 30/05/2018

Actual: 30/05/2018

Study start date

Planned: 01/01/2017

Actual: 01/01/2017

Data analysis start date

Planned: 01/11/2018

Date of interim report, if expected

Planned: 31/12/2018

Actual: 20/12/2018

Date of final study report

Planned: 31/07/2020

Actual: 24/06/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Allergan

Study protocol

Initial protocol

Poison Center Eluxadoline Study Protocol 07AUG2018_Redacted

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only

Other study registration identification numbers and links

CMO-EPI-GI-0582