check_circleStudy Completed

Pharyngitis

Bayer Identifier:

15772

ClinicalTrials.gov Identifier:

NCT01453400

EudraCT Number:

Not Available

EU CT Number:

Not Available
Evaluate the time of pain relief of fast acting aspirin versus acetaminophen in subjects diagnosed with sore throat pain

Trial 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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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
  • - 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

Trial summary

Enrollment Goal
177
Trial Dates
September 2011 - April 2012
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Bayer Advanced Aspirin (Acetylsalicylic acid, BAY1019036)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Storrs, 06269-2011, United States

Primary Outcome

  • Time to meaningful pain relief from the Sore Throat Pain Intensity Scale (STPIS) 100 mm visual analog scale
    date_rangeTime Frame:
    Up to two hours
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Global assessment of the investigational product as a pain reliever by grading from 0 to 4 (from poor to excellent)
    date_rangeTime Frame:
    Two hours postdose or immediately before the intake of rescue medication
    enhanced_encryption
    Safety Issue:
    No
  • Time to first perceptible relief (defined as the time when the subject presses the first stopwatch)
    date_rangeTime Frame:
    Up to two hours
    enhanced_encryption
    Safety Issue:
    No
  • Time weighted sum of pain intensity differences (PID) scores over first hour
    date_rangeTime Frame:
    Up to one hour
    enhanced_encryption
    Safety Issue:
    No
  • Time weighted sum of pain intensity differences (PID) scores over 2 hours
    date_rangeTime Frame:
    Up to two hours
    enhanced_encryption
    Safety Issue:
    No
  • Percentage difference from baseline Sore Throat Pain Intensity Scale (STPIS) to STPIS at time of meaningful relief
    date_rangeTime Frame:
    Up to two hours
    enhanced_encryption
    Safety Issue:
    No

Trial design

Onset of Action of a Fast Release Aspirin Tablet and Acetaminophen Caplet in Sore Throat Pain
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
3

Additional Information

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