NCT02542098 is a Phase 2 clinical trial of HYD tablets in Pain, sponsored by Purdue Pharma LP.

Who is sponsoring NCT02542098?

NCT02542098 is sponsored by Purdue Pharma LP.

What drugs are being tested in NCT02542098?

Interventions in NCT02542098: HYD tablets.

Is NCT02542098 still recruiting?

NCT02542098 is currently withdrawn. Last updated 21 April 2017.

Last reviewed 2017-04-21 · How we verify

NCT02542098

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase 2B, Open-label, Multicenter Study Evaluating the Safety, Pharmacokinetics, and Effectiveness of Hydrocodone Bitartrate Extended-Release Tablets (HYD) in Children, Aged 12 to 17 Years Inclusive, With Moderate to Severe Malignant and/or Nonmalignant Pain Requiring Around-the-Clock Opioid Analgesics

Withdrawn Phase 2 Last updated 21 April 2017

What this trial tests

Phase 2 trial testing HYD tablets in Pain. Withdrawn.

Timeline

1 January 2017

Primary endpoint
1 July 2019

1 July 2019

Quick facts

Lead sponsor	Purdue Pharma LP
Phase	Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Start date	1 January 2017
Primary completion	1 July 2019
Estimated completion	1 July 2019

Drugs / interventions tested

HYD tablets — full drug profile →

Conditions studied

Pain — all drugs for Pain →

Sponsor

Purdue Pharma LP — full company profile →

Who can join

Adults 12 to 17, any sex, with Pain. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

The number of participants with adverse events as a measure of safety
Time frame: Up to 4 weeks (during the study) and 7-10 days poststudy (safety follow-up assessment).
Pharmacokinetic analysis to characterize the apparent volume of distribution (Vc/F) of hydrocodone following oral administration
Time frame: Day 1, End of week 2, End of week 4
Pharmacokinetic analysis to characterize the apparent oral clearance (CL/F) of hydrocodone following oral administration
Time frame: Day 1, End of week 2, End of week 4

Sponsor's own description

The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and effectiveness of Hydrocodone Bitartrate (HYD) tablets in children with moderate to severe pain requiring around-the-clock opioid analgesics.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

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Other Purdue Pharma LP trials

Trials by the same sponsor.

NCT06719986 — Pharmacodynamic Evaluation of Intramuscular Nalmefene Autoinjector 1.5 mg Compared to Intranasal Narcan 4 mg · Phase 1 · completed
NCT04987762 — Safety and Tolerability Study of Adhansia XR® Extended-Release Capsules in Children · Phase 4 · terminated
NCT04507204 — Real-World Evidence of Duration of Effect of Adhansia XR (Extended-Release) for Treatment of Attention-Deficit/Hyperacti · Phase 4 · terminated
NCT03299556 — Effect of Wearable Health Technology on Patients Treated for Chronic Pain at Geisinger Health System · completed
NCT03028870 — A Study to Evaluate the Analgesic Efficacy and Safety of V120083 in Subjects With Osteoarthritis (OA) of the Knee · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02542098 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Purdue Pharma LP
Last refreshed: 21 April 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02542098.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing