Open label, multinational, multicentre, prospective, real world observational study of Naloxegol for patients with cancer pain diagnosed with Opioid Induced Constipation (OIC). (NACASY)

Study summary

No information provided.

Study identification

• EU PAS number:
  EUPAS23610
• Study ID:
  33677
• Official title and acronym:
  Open label, multinational, multicentre, prospective, real world observational study of Naloxegol for patients with cancer pain diagnosed with Opioid Induced Constipation (OIC). (NACASY)
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Finland

  France

  Germany

  Italy

  Netherlands

  Spain

  Sweden

  United Kingdom
• Study description:
  Opioids have been the cornerstone of analgesic treatment for severe chronic pain. Opioid Induced Constipation(OIC) is the most commonly reported adverse effect associated with opioids, and compromises patient satisfaction with analgesic treatment, adherence to analgesic treatment regimens and quality of life. Guidelines recommend laxatives for the management of OIC in patients with cancer. In patients who do not respond to standard laxatives, peripherally acting muopioids receptor antagonists (PAMORAs) are a valid option. Naloxegol is an oral PAMORA indicated for the treatment of OIC in adult patients who have had an inadequate response to standard laxatives. No study results evaluating the use of Naloxegol in cancer patients according to routine clinical practice outside of controlled clinical trials are yet available. This study aims to evaluate the safety and efficacy of Naloxegol in a real-world treatment study in patients with cancer pain diagnosed with OIC.
• Study status:
  Finalised

Research institutions and networks

Institutions

Kiowa Kirin International

Study timelines

Date when funding contract was signed

Planned:13/09/2018

Actual:13/09/2018

Study start date

Planned:31/07/2018

Actual:14/08/2018

Data analysis start date

Planned:14/05/2020

Actual:03/11/2020

Date of interim report, if expected

Actual:28/01/2020

Date of final study report

Planned:06/07/2020

Actual:06/05/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Kyowa Kirin International plc.

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable