Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids

Recruiting Phase 1 Phase 2 Interventional Study
Opioid-Induced Constipation (OIC)
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
2 – 18
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Supportive Care
Participants needed
24 (estimated)
Sponsor
Shionogi · Industry
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About This Trial

The primary objective of this study is to evaluate the pharmacokinetic (PK) profile of naldemedine and nor-naldemedine after a single oral dose of naldemedine in pediatric participants who are receiving or about to receive opioids.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: Disease Characteristics * Participants with cancer or non-cancer pain who are receiving (or who are about to receive) acute or chronic treatment with opioids. * Participants with either newly diagnosed constipation, a history of constipation treated with laxatives, or are expec…
Contacts

Shionogi Clinical Trials Administrator Clinical Support Help Line

800-849-9707

Shionogiclintrials-admin@shionogi.co.jp

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