Evaluate the Time of Pain Relief of Fast Acting Aspirin Versus Acetaminophen in Subjects Diagnosed With Sore Throat Pain (Tarot)

Onset of Action of a Fast Release Aspirin Tablet and Acetaminophen Caplet in Sore Throat Pain

This study is to evaluate the onset of relief provided by a single, oral dose of fast release aspirin 1000 mg compared to acetaminophen 1000 mg and placebo in subjects with sore throat pain.

Study Overview

• Status: Completed
• Conditions: Pharyngitis
• Intervention / Treatment: Drug: Acetylsalicylic Acid (Aspirin, BAY1019036) + placebo; Drug: Acetaminophen + placebo; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 177
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Storrs, Connecticut, United States, 06269-2011

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy, ambulatory, male and female subjects ≥ 18 years of age
• Presence of sore throat due to upper respiratory tract infection (URTI)
• Onset of sore throat pain within six days of the screening period
• Baseline sore throat pain intensity score ≥ 60 mm on the Sore Throat Pain Intensity Scale
• Have a score ≥ 5 on the Tonsillopharyngitis Assessment
• Female subjects of childbearing potential who are currently sexually active must be using a medically acceptable form of birth control for at least one month prior to screening (three months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, Nuvaring, Depo-Provera, or double-barrier and have a negative pregnancy test at screening/treatment period. Female subjects of non-childbearing potential must be amenorrheic for at least two years or had a hysterectomy and/or bilateral oophorectomy.
• Understand the pain rating assessments

Exclusion Criteria:

• History of hypersensitivity to aspirin, salicylates, other nonsteroidal anti-inflammatory drugs, acetaminophen, opioid analgesics, and similar drugs
• Use of any "cold medication" (i.e. decongestants, antihistamines, expectorants, antitussives) within four hours preceding administration of the investigational product
• Use of any immediate release analgesic/antipyretic within four hours or use of any sustained release or long-acting analgesic/antipyretic within twelve hours preceding administration of the investigational product
• Consumption of alcoholic beverages, or foods and beverages containing xanthines within two hours prior to administration of the investigational product
• Use of any sore throat lozenges, sprays, cough drops, menthol-containing products within one hour preceding administration of the investigational product
• Presence of cough that causes throat discomfort
• Presence of mouth-breathing or any respiratory condition that, in the Investigator's judgment, could compromise breathing
• Evidence of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases, or malignancies for which aspirin or acetaminophen is contraindicated
• Relevant concomitant disease such as medically uncontrolled asthma (exercise induced asthma is permitted), chronic sinusitis or nasal structural abnormalities causing greater than fifty percent obstruction
• History of gastrointestinal bleeding or perforation related to previous non-steroidal anti-inflammatory therapy.
• Current or past history of a bleeding disorder
• Self reported alcoholism or drug abuse within two years prior to screening or routine consumption of three or more alcohol containing beverages per day
• Habituation to analgesic drugs or tranquilizers (i.e., routine use of five or more times per week for greater than three weeks)
• Acute illness, local infection, or disease (other than URTI with pharyngeal infection) that can interfere with the conduct of the study
• Current use of blood thinning (anticoagulant), low dose aspirin, or steroid drug
• Has initiated treatment for depression within the past thirty days
• Females who are pregnant or lactating

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 2	Drug: Acetaminophen + placebo; Single dose, 2 x 500 mg Acetaminophen caplets (1000 mg) + 2 x placebo fast release Aspirin tablets
Experimental: Arm 1	Drug: Acetylsalicylic Acid (Aspirin, BAY1019036) + placebo; Single dose, 2 x 500 mg fast release aspirin tablets (1000 mg) + 2 x placebo acetaminophen caplets
Placebo Comparator: Arm 3	Drug: Placebo; Single dose, 2 x placebo Acetaminophen caplets + 2 x placebo fast release Aspirin tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to meaningful pain relief from the Sore Throat Pain Intensity Scale (STPIS) 100 mm visual analog scale	Up to two hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Global assessment of the investigational product as a pain reliever by grading from 0 to 4 (from poor to excellent)	Two hours postdose or immediately before the intake of rescue medication
Time to first perceptible relief (defined as the time when the subject presses the first stopwatch)	Up to two hours
Time weighted sum of pain intensity differences (PID) scores over first hour	Up to one hour
Time weighted sum of pain intensity differences (PID) scores over 2 hours	Up to two hours
Percentage difference from baseline Sore Throat Pain Intensity Scale (STPIS) to STPIS at time of meaningful relief	Up to two hours

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

General Publications

• Voelker M, Schachtel BP, Cooper SA, Gatoulis SC. Efficacy of disintegrating aspirin in two different models for acute mild-to-moderate pain: sore throat pain and dental pain. Inflammopharmacology. 2016 Feb;24(1):43-51. doi: 10.1007/s10787-015-0253-0. Epub 2015 Nov 24.

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2011
• Primary Completion (Actual): April 5, 2012
• Study Completion (Actual): April 6, 2012

Study Registration Dates

• First Submitted: October 13, 2011
• First Submitted That Met QC Criteria: October 13, 2011
• First Posted (Estimate): October 17, 2011

Study Record Updates

• Last Update Posted (Actual): December 7, 2018
• Last Update Submitted That Met QC Criteria: December 6, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: aspirin; acetylsalicylic acid; pharyngitis; sore throat
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Pharyngitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin; Acetaminophen
• Other Study ID Numbers: 15772

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No