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NCT03088800

IBUPAP Study for Pain Management in Children

Completed Phase 2 Results posted Last updated 25 March 2021
What this trial tests

Phase 2 trial testing Ibuprofen in Pain Management in 90 participants. Completed in 30 July 2020.

Timeline
30 April 2018
Primary endpoint
31 October 2019
30 July 2020

Quick facts

Lead sponsorAntonios Likourezos
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment90
Start date30 April 2018
Primary completion31 October 2019
Estimated completion30 July 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Antonios Likourezos — full company profile →

Who can join

Adults 3 to 17, any sex, with Pain Management. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pain Score at 60 Minutes Primary · 60 minutes

Pain Score via Numeric Rating Scale or FACES pain scale at 60 minutes from baseline ( ranging from 0 to 10, with 0 being no pain, 5 being moderate pain, and 10 being very severe pain)

GroupValue95% CI
Oral Ibuprofen2.72± 2.15
Oral APAP3.10± 1.92
Oral Ibuprofen and Oral APAP2.77± 2.08

Sponsor's own description

Current literature supports ibuprofen and APAP are the most commonly used analgesics in the pediatric ED for acute traumatic/non-traumatic pain. However, the analgesic benefits of combination ibuprofen and APAP in this specific setting does not exist, but instead only as it applies to pediatric patients with postoperative pain. Thus, we have designed a double-blind, randomized, controlled clinical trial to evaluate analgesic efficacy, safety and feasibility of combination therapy to potentially broaden its clinical application in the pediatric ED. The investigators' hypothesize that combination oral ibuprofen and APAP therapy is superior to either drug alone and is an excellent analgesic modality for controlling acute traumatic/non-traumatic pain in the pediatric ED.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Ibuprofen

Trials testing the same drug.

Other recruiting trials for Pain Management

Currently open trials in the same condition.

Other Antonios Likourezos trials

Trials by the same sponsor.

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Data sources for this page

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/NCT03088800.

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