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Naloxegol Health Outcome Post Authorisation Safety Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02813369
Recruitment Status : Recruiting
First Posted : June 27, 2016
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Kyowa Kirin Pharmaceutical Development Ltd

Brief Summary:
This post-authorization observational safety study (PASS) monitors clinically important identified and potential risks within a cohort of patients treated with naloxegol, including the occurrence of bowel perforation, acute myocardial infarction (MI), stroke, cardiovascular (CV)-specific mortality, all-cause mortality, hypertension, opioid withdrawal, abdominal pain, diarrhea, syncope, and change in pain severity. This study is part of a broader post-marketing commitment to augment routine evaluation of the safety profile of naloxegol in clinical practice.

Condition or disease Intervention/treatment
Opioid Induced Constipation Drug: naloxegol Drug: non-PAMORA laxative

Detailed Description:

The overall research goal for this study is to provide additional data to characterize the safety of naloxegol in the indicated population, grouped by cancer or non-cancer, and within at-risk vulnerable non-cancer populations identified in the naloxegol risk management plan (RMP) by describing type and frequency of identified and potential risks (including bowel perforation, acute MI, stroke, CV-specific mortality, all-cause mortality, hypertension, opioid withdrawal, abdominal pain, diarrhea, syncope, and change in pain severity) in patients ≥18 years of age who were treated with opioids chronically and subsequently treated with naloxegol in routine post-authorization use.

The primary objective of the study is to assess the incidence risk of bowel perforation, acute MI, stroke, all-cause mortality, and hypertension in patients treated with naloxegol (Naloxegol Inception Cohort, (NIC)), grouped by cancer or non cancer, a Concurrent Reference Cohort (CRC) by cancer or non-cancer, and by pre-specified non-cancer sub-populations that include patients aged ≥65 years, pregnant patients, patients with prior CV, patients with prior renal or hepatic impairment, patients with concurrent methadone use, and patients with concurrent use of cytochrome P450 (CYP) 3A inhibitors/inducer or P-glycoprotein (Pgp) modulators.

An exploratory objective of the study is to assess the incidence risk of CV-specific mortality, opioid withdrawal, abdominal pain, diarrhea, syncope, and change in pain severity in patients treated with naloxegol (NIC) grouped by cancer and non cancer, a CRC grouped by cancer or non cancer, and by pre-specified non-cancer sub-populations that include patients aged ≥65 years, pregnant patients, patients with prior cardiovascular risk, patients with prior renal or hepatic impairment, patients with concurrent methadone use, and patients with concurrent use of CYP3A inhibitors/inducer or Pgp modulators.

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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: An Observational Post-Authorisation Safety Study (PASS) of MOVENTIG® (Naloxegol) Among Patients Aged 18 Years and Older Treated With Opioids Chronically
Study Start Date : July 2016
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Naloxegol

Group/Cohort Intervention/treatment
naloxegol
patients exposed to naloxegol
Drug: naloxegol
non-interventional study where patients are exposed to naloxegol during normal clinical practice

non-PAMORA laxative
patient exposed to non-peripherally acting mu-opioid receptor antagonist (PAMORA) laxative
Drug: non-PAMORA laxative
non-interventional study where patients are exposed to non-peripherally acting mu-opioid receptor antagonist (PAMORA) laxative




Primary Outcome Measures :
  1. Presence (yes/no) of bowel perforation [ Time Frame: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years ]
  2. Presence (yes/no) of acute MI [ Time Frame: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years ]
  3. Presence (yes/no) of stroke [ Time Frame: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years ]
  4. Presence (yes/no) of all-cause mortality [ Time Frame: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years ]
  5. Presence (yes/no) of hypertension [ Time Frame: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years ]

Other Outcome Measures:
  1. Presence of (yes/no) CV-specific mortality [ Time Frame: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years ]
  2. Presence of (yes/no) opioid withdrawal [ Time Frame: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years ]
  3. Presence of (yes/no) abdominal pain [ Time Frame: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years ]
  4. Presence of (yes/no) diarrhea [ Time Frame: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years ]
  5. Presence of (yes/no) syncope [ Time Frame: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years ]
  6. Presence of (yes/no) change in pain severity [ Time Frame: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients in the targeted European countries who receive prescriptions for naloxegol will be identified for inclusion in the naloxegol inception cohort, while patients in these countries who receive a prescription for a non-PAMORA laxative will be identified for inclusion in the concurrent reference cohort. All patients in this study will be ≥18 years of age; have ≥1 year of continuous data available; have exposure to current, regular opioid use; and have no prior exposure to PAMORA laxatives alvimopan, methylnaltrexone, or naloxone + opioid combination (including fixed-dose combinations).
Criteria

Inclusion Criteria:

1. Patient receives a new prescription for naloxegol or a non-PAMORA laxative. (Note: Only non-PAMORA laxatives that are approved/marketed in the European Union at the time naloxegol is authorized are permitted.)

Exclusion Criteria:

  1. Patients <18 years of age on cohort entry date
  2. Patients with <1 year of continuous data available prior to cohort entry date
  3. Patients without exposure to current regular opioid use defined by >30 days of opioid exposure within the 180 days prior to and inclusive of the cohort entry date
  4. Patients with evidence of a cancer indicator (diagnosis or treatment) prior to cohort entry date
  5. Exposure to PAMORA laxatives, alvimopan, methylnaltrexone, or naloxone + opioid combination (including fixed-dose combinations) prior to cohort entry date

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02813369


Contacts
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Contact: Fiona Miller 00 44 1896 664 000 fiona.miller@kyowakirin.com

Locations
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Germany
Research Site Recruiting
Bremen, Germany
Netherlands
Research Site Recruiting
Utrecht, Netherlands
United Kingdom
Research Site Recruiting
Sutton, Surrey, United Kingdom
Sponsors and Collaborators
Kyowa Kirin Pharmaceutical Development Ltd
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Responsible Party: Kyowa Kirin Pharmaceutical Development Ltd
ClinicalTrials.gov Identifier: NCT02813369    
Other Study ID Numbers: D3820R00009
First Posted: June 27, 2016    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive
Naloxegol
Laxatives
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Gastrointestinal Agents