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

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: October 13, 2011
Last updated: July 7, 2014
Last verified: July 2014
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.

Condition Intervention Phase
Drug: Acetylsalicylic Acid (Aspirin, BAY1019036) + placebo
Drug: Acetaminophen + placebo
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Onset of Action of a Fast Release Aspirin Tablet and Acetaminophen Caplet in Sore Throat Pain

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Time to meaningful pain relief from the Sore Throat Pain Intensity Scale (STPIS) 100 mm visual analog scale [ Time Frame: Up to two hours ]

Secondary Outcome Measures:
  • Global assessment of the investigational product as a pain reliever by grading from 0 to 4 (from poor to excellent) [ Time Frame: 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) [ Time Frame: Up to two hours ]
  • Time weighted sum of pain intensity differences (PID) scores over first hour [ Time Frame: Up to one hour ]
  • Time weighted sum of pain intensity differences (PID) scores over 2 hours [ Time Frame: Up to two hours ]
  • Percentage difference from baseline Sore Throat Pain Intensity Scale (STPIS) to STPIS at time of meaningful relief [ Time Frame: Up to two hours ]

Enrollment: 177
Study Start Date: September 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Active Comparator: Arm 2 Drug: Acetaminophen + placebo
Single dose, 2 x 500 mg Acetaminophen caplets (1000 mg) + 2 x placebo fast release Aspirin tablets
Placebo Comparator: Arm 3 Drug: Placebo
Single dose, 2 x placebo Acetaminophen caplets + 2 x placebo fast release Aspirin tablets


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01453400

United States, Connecticut
Storrs, Connecticut, United States, 06269-2011
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Bayer Identifier: NCT01453400     History of Changes
Other Study ID Numbers: 15772
Study First Received: October 13, 2011
Last Updated: July 7, 2014

Keywords provided by Bayer:
acetylsalicylic acid
sore throat

Additional relevant MeSH terms:
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics processed this record on April 21, 2017