Phase I Pharmacokinetics and Safety Study of Naloxegol in Paediatric OIC Patients

  • STATUS
    Recruiting
  • End date
    Nov 27, 2021
  • participants needed
    36
  • sponsor
    Kyowa Kirin Pharmaceutical Development Ltd
Updated on 27 January 2021
Investigator
Development Division Project Management Department
Primary Contact
Schneider Children Medical Center (6.6 mi away) Contact
+26 other location

Summary

To characterize the pharmacokinetics (PK) of naloxegol after single oral dose and through population PK in paediatric patients with opioid induced constipation (OIC) or at risk of OIC.

Details
Condition Constipation, Signs and Symptoms, Digestive, Constipation, Signs and Symptoms, Digestive, Constipation, Signs and Symptoms, Digestive, Constipation, Signs and Symptoms, Digestive, Constipation, Signs and Symptoms, Digestive, Constipation, Signs and Symptoms, Digestive, Constipation, Signs and Symptoms, Digestive
Treatment Naloxegol
Clinical Study IdentifierNCT02099591
SponsorKyowa Kirin Pharmaceutical Development Ltd
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

malignant or non-malignant pain who are receiving or (are about to receive) acute or chronic treatment with opioids
newly diagnosed constatipation, with history of constipation treated with laxatives or expected to develop constipation after opioid treatment
ability to be present in the clinic for at least 10 hours following the first study drug for blood sampling and to return at 24 hours for blood sampling

Exclusion Criteria

Current acute or chronic use of methadone
History of an neoplasm or an ongoing gastrointestinal-related issue
Signs or symptoms of gastrointestinal obstruction
History of prolonged neutropenia or thrombocytopenia with clinical sequelae
Patients currently receiving the first cycle of chemotherapy
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note