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.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01453400
First received: October 13, 2011
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Time to first perceptible relief (defined as the time when the subject presses the first stopwatch) [ Time Frame: Up to two hours ] [ Designated as safety issue: No ]
  • Time weighted sum of pain intensity differences (PID) scores over first hour [ Time Frame: Up to one hour ] [ Designated as safety issue: No ]
  • Time weighted sum of pain intensity differences (PID) scores over 2 hours [ Time Frame: Up to two hours ] [ Designated as safety issue: No ]
  • Percentage difference from baseline Sore Throat Pain Intensity Scale (STPIS) to STPIS at time of meaningful relief [ Time Frame: Up to two hours ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01453400

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

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01453400     History of Changes
Other Study ID Numbers: 15772
Study First Received: October 13, 2011
Last Updated: July 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Bayer:
aspirin
acetylsalicylic acid
pharyngitis
sore throat

Additional relevant MeSH terms:
Pharyngitis
Otorhinolaryngologic Diseases
Pharyngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Stomatognathic Diseases
Acetaminophen
Aspirin
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antipyretics
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014