Reduction in Pain Intensity Following IV or Oral Pain-relieving Products

Phase 4

Completed

• Conditions: Pain
• Interventions: Drug: IV Acetaminophen (Treatment A); Drug: Oral Acetaminophen (Treatment B); Drug: Placebo (Treatment C); Other: Morphine (Treatment D)

• Registration Number: NCT02678416
• Lead Sponsor: Mallinckrodt

Brief Summary

The purpose of this study is to evaluate two experimental pain models to see if they would be useful for comparing different products for reduction in pain intensity.

The models evaluated were the ultraviolet-B (UVB) burn and intradermal capsaicin experimental pain models. Medications compared were a single dose each, of intravenous (IV) acetaminophen, oral acetaminophen, placebo, and IV morphine.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-07
• Study First Submitted: 2016-02-05
• Study First Submitted QC: 2016-02-08
• Study First Posted: 2016-02-09
• Primary Completion: 2016-06-13
• Study Completion: 2016-06-13
• Results First Submitted: 2017-06-28
• Status Verified: 2019-11
• Results First Submitted QC: 2019-11-27
• Results First Posted: 2019-12-20
• Last Update Submitted: 2020-01-22
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 79

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
IV Acetaminophen	IV Acetaminophen (Treatment A)	All participants receive IV acetaminophen as one of 4 interventions in random sequence
IV Acetaminophen	Placebo (Treatment C)	All participants receive IV acetaminophen as one of 4 interventions in random sequence
Oral Acetaminophen	Oral Acetaminophen (Treatment B)	All participants receive oral acetaminophen as one of 4 interventions in random sequence
Oral Acetaminophen	Placebo (Treatment C)	All participants receive oral acetaminophen as one of 4 interventions in random sequence
Placebo	Placebo (Treatment C)	All participants receive placebo as one of 4 interventions in random sequence
Morphine	Placebo (Treatment C)	All participants receive morphine as one of 4 interventions in random sequence
Morphine	Morphine (Treatment D)	All participants receive morphine as one of 4 interventions in random sequence

Primary Outcome Measures

Name	Time	Method
Part 1: Change From Baseline in Pain Intensity at Hour 6 Using the Thermal Suprathreshold Pain in the Ultraviolet-B (UVB) Burn Pain Model	within 6 hours	The UVB burn pain model is a validated screening tool for pain killers in clinical drug development. A temperature of 50 degrees centigrade (°C) is used to burn the participant for 5 seconds. Then the participant rates his pain on a scale from 0 (no pain) to 10 (most intense pain). That score is recorded as baseline. Then the participant rates his pain again six hours after taking the assigned medication. The average at baseline is subtracted from the average at hour 6. Because this is a measure of reduction in pain intensity, a higher score is better (it means there is more pain relief).

Secondary Outcome Measures

Name	Time	Method
Part 2: Observed Thermal Suprathreshold Pain Intensity in the UVB Burn Area	within 6 hours	Participants rated their pain intensity on a scale of 0 (no pain) to 10 (most intense pain). The observed mean and standard deviation are disclosed through Hour 6

Trial Locations

Locations (1)

Pharmaceuticals Research Associates, Inc. (PRA); 🇺🇸 Salt Lake City, Utah, United States