At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 50 enrolled

Drug / intervention

Oral Acetaminophen +4 moredrug

Likely dose

Oral Acetaminophen 500 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02848729

NCT02848729Phase 4Completed

Compare CT.gov

A Randomized, 2-Way, Parallel, Single-Blind Pharmacokinetic Study to Evaluate the Interaction Between Intravenous Morphine and Orally or Intravenously Administered Acetaminophen in Healthy Subjects

Mallinckrodt·interventional·Posted Jul 28, 2016·Updated Feb 5, 2020

In Brief

A Phase 4 clinical trial evaluating Oral Acetaminophen, IV Acetaminophen, and 3 other interventions for Pain. Completed, enrolled 50 participants across 3 sites.

Detailed Summary

Morphine is the opioid used to treat pain after surgery. Acetaminophen (called APAP) can reduce the amount of opioids needed for this. The problem is that morphine slows down digestion. That can delay pain relief from APAP pills. It can even change what the body does to the drug \[pharmacokinetics (PK)\]. Some doctors have started using intravenous (IV) APAP with morphine, instead of the pills. This study will measure the PK of APAP pills and IV when used with morphine in healthy volunteers. IV APAP will likely be more effective and cause fewer side effects when used with morphine to treat pain after surgery.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsPain

CountriesUnited States

Collaborators--

Timeline

Phase 4CompletedFinished

20162017201820192020202120222023202420252026

Enrollment StartFeb 2016

Primary CompletionMar 2016

First PostedJul 2016

TodayJul 2026

First PostedJul 28, 2016

Enrollment StartFeb 1, 2016

Primary CompletionMar 1, 2016

TodayJul 2, 2026

Enrollment to primary: 1 monthPosted 9.9 years ago

Interventions

Oral Acetaminophendrug

Acetaminophen for oral administration (2 tablets, 500 mg/tablet)

IV Acetaminophendrug

Acetaminophen for intravenous (IV) administration (1,000 mg/100 mL)

IV Morphinedrug

Morphine for IV administration (0.125 mg/kg)

Placebo Tabletsdrug

Placebo tablets matching oral acetaminophen

Salinedrug

Saline placebo matching IV acetaminophen