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NCT02746263

Multicenter Study to Compare Intravenous and Oral Acetaminophen for the Treatment of Acute Moderate to Severe Pain

Terminated Phase 4 Results posted Last updated 19 November 2019
What this trial tests

Phase 4 trial testing IV acetaminophen in Acute Pain, Postoperative in 1 participant. Terminated before completion.

Timeline
27 April 2016
Primary endpoint
5 May 2016
5 May 2016

Quick facts

Lead sponsorMallinckrodt
PhasePhase 4
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment1
Start date27 April 2016
Primary completion5 May 2016
Estimated completion5 May 2016
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Mallinckrodt — full company profile →

Who can join

Adults 50 to 90, any sex, with Acute Pain, Postoperative. Patients with the condition only — healthy volunteers not accepted.

Adverse events — posted to ClinicalTrials.gov

Time frame: 9 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

IV Acetaminophen/Morphine
Serious: 0
Deaths: 0
Oral Acetaminophen/Morphine
Serious: 0/1 (0%)
Deaths: 0/1
Other adverse events (9 terms — click to expand)

ReactionSystemIV Acetaminophen/MorphineOral Acetaminophen/Morphine
Acute blood loss anemiaBlood and lymphatic system disorders
Diffuse bronchial wall thickeningRespiratory, thoracic and mediastinal disorders
Intermittent thrombocytopeniaBlood and lymphatic system disorders
Intermittent leucocytosisBlood and lymphatic system disorders
Persistent sinus tachycardiaCardiac disorders
Postoperative painGeneral disorders
Pulmonary hypertensionRespiratory, thoracic and mediastinal disorders
Stress hyperglycemiaEndocrine disorders
Suspicion of adrenal insufficiencyEndocrine disorders

Data from ClinicalTrials.gov NCT02746263 adverse events section.

Sponsor's own description

The purpose of this study is to compare intravenous (IV) and oral acetaminophen for the treatment of acute moderate to severe pain in combination with standard patient-controlled analgesia (PCA) in adult subjects following total knee replacement.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of IV acetaminophen

Trials testing the same drug.

Other recruiting trials for Acute Pain, Postoperative

Currently open trials in the same condition.

Other Mallinckrodt trials

Trials by the same sponsor.

Verify against primary sources

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/NCT02746263.

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