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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01453400
Recruitment Status : Completed
First Posted : October 17, 2011
Last Update Posted : December 7, 2018
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Pharyngitis Drug: Acetylsalicylic Acid (Aspirin, BAY1019036) + placebo Drug: Acetaminophen + placebo Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 177 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (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
Actual Study Start Date : September 27, 2011
Actual Primary Completion Date : April 5, 2012
Actual Study Completion Date : April 6, 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sore Throat

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. Time to first perceptible relief (defined as the time when the subject presses the first stopwatch) [ Time Frame: Up to two hours ]
  3. Time weighted sum of pain intensity differences (PID) scores over first hour [ Time Frame: Up to one hour ]
  4. Time weighted sum of pain intensity differences (PID) scores over 2 hours [ Time Frame: Up to two hours ]
  5. Percentage difference from baseline Sore Throat Pain Intensity Scale (STPIS) to STPIS at time of meaningful relief [ Time Frame: Up to two hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01453400

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Bayer Identifier: NCT01453400    
Other Study ID Numbers: 15772
First Posted: October 17, 2011    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
acetylsalicylic acid
sore throat
Additional relevant MeSH terms:
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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