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Naloxegol Drug Utilization PASS

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: NCT02813148
Recruitment Status : Recruiting
First Posted : June 24, 2016
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Kyowa Kirin Pharmaceutical Development Ltd

Brief Summary:
This post-authorization observational safety study determines the characteristics of patients prescribed naloxegol at time of first prescription and treatment patterns of naloxegol in follow-up in the United Kingdom (UK), Norway, Sweden, and Germany.

Condition or disease Intervention/treatment
Opioid Induced Constipation Drug: Naloxegol

Detailed Description:

The overall research questions for this study are: 1) What are the demographic, clinical, and treatment characteristics (including dose) at baseline of patients prescribed naloxegol in real-world practice (including the use of naloxegol in non-indicated populations)? and 2) What are the treatment patterns of naloxegol utilization during follow-up?

Primary objectives:

  1. To describe the characteristics of patients prescribed naloxegol at time of first prescription (demographics, targeted comorbidities, targeted comedications, provider characteristics, and indication characteristics).
  2. To describe any of the following treatment patterns:

    • Discontinuation of naloxegol (permanently during the observation period)
    • Switching from naloxegol to other drug(s) potentially used by patients with opioid induced constipation (OIC)
    • Prescription of other drug(s) potentially used by patients with OIC in the same period when naloxegol is prescribed (augmentation)
    • Restart in the prescription of naloxegol (after temporary discontinuation or treatment holiday)
    • Continuous treatment with naloxegol during the study period
    • Change in dosing

Exploratory objective:

1. To identify predictors of length of naloxegol use

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: An Observational Post-Authorization Safety Study (PASS) of MOVENTIG® (Naloxegol) Drug Utilization in Selected European Populations
Study Start Date : July 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Naloxegol


Intervention Details:
  • Drug: Naloxegol
    Non-interventional study of drug utilization


Primary Outcome Measures :
  1. discontinuation [ Time Frame: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years ]
    Presence (yes/no) of a patient discontinuing naloxegol (i.e. permanently during the observation period)

  2. Switching [ Time Frame: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years ]
    Presence (yes/no) of a patient switching from naloxegol to other drug(s) potentially used by patients with opioid induced constipation (OIC)

  3. Augmentation [ Time Frame: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years ]
    Presence (yes/no) of a patient augmenting therapy with a prescription of other drug(s) potentially used by patients with OIC in the same period when naloxegol is prescribed

  4. Restart [ Time Frame: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years ]
    Presence (yes/no) of a patient restarting the prescription of naloxegol (after temporary discontinuation or treatment holiday)

  5. Continuous Use [ Time Frame: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years ]
    Presence (yes/no) of a patient continuously treated with naloxegol during the study period

  6. Dose Change [ Time Frame: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years ]
    Presence (yes/no) of a patient changing dosing of naloxegol



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 countries who are newly prescribed naloxegol will be identified for inclusion. Patients analyzed in this study will be those who have at least 12 months of continuous data available prior to first prescription. The number of patients who do not have at least 12 months of prior data will be reported for completeness.
Criteria

Inclusion Criteria:

  1. The patient has at least 1 prescription of naloxegol in his/her medical record anytime during the study period.
  2. The patient has at least 12 months of computerized records prior to the first prescription of naloxegol (index date)

Exclusion Criteria:

  • No exclusion criteria will be applied

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): NCT02813148


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

Locations
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Finland
Research Site Recruiting
Espoo, Finland
Germany
Research Site Recruiting
Frankfurt am Main, Germany
United Kingdom
Research Site Recruiting
Sutton, United Kingdom
Sponsors and Collaborators
Kyowa Kirin Pharmaceutical Development Ltd
Investigators
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Study Director: Rob Swain Kyowa Kirin
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Responsible Party: Kyowa Kirin Pharmaceutical Development Ltd
ClinicalTrials.gov Identifier: NCT02813148    
Other Study ID Numbers: D3820R00006
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive
Naloxegol
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents