Evaluate the Time of Pain Relief of Fast Acting Aspirin Versus Acetaminophen in Subjects Diagnosed With Sore Throat Pain (Tarot)
Primary Purpose
Pharyngitis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Acetylsalicylic Acid (Aspirin, BAY1019036) + placebo
Acetaminophen + placebo
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pharyngitis focused on measuring aspirin, acetylsalicylic acid, pharyngitis, sore throat
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Arm 1
Arm 2
Arm 3
Arm Description
Outcomes
Primary Outcome Measures
Time to meaningful pain relief from the Sore Throat Pain Intensity Scale (STPIS) 100 mm visual analog scale
Secondary Outcome Measures
Global assessment of the investigational product as a pain reliever by grading from 0 to 4 (from poor to excellent)
Time to first perceptible relief (defined as the time when the subject presses the first stopwatch)
Time weighted sum of pain intensity differences (PID) scores over first hour
Time weighted sum of pain intensity differences (PID) scores over 2 hours
Percentage difference from baseline Sore Throat Pain Intensity Scale (STPIS) to STPIS at time of meaningful relief
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01453400
Brief Title
Evaluate the Time of Pain Relief of Fast Acting Aspirin Versus Acetaminophen in Subjects Diagnosed With Sore Throat Pain
Acronym
Tarot
Official Title
Onset of Action of a Fast Release Aspirin Tablet and Acetaminophen Caplet in Sore Throat Pain
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
September 27, 2011 (Actual)
Primary Completion Date
April 5, 2012 (Actual)
Study Completion Date
April 6, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pharyngitis
Keywords
aspirin, acetylsalicylic acid, pharyngitis, sore throat
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
177 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Title
Arm 3
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Acetylsalicylic Acid (Aspirin, BAY1019036) + placebo
Intervention Description
Single dose, 2 x 500 mg fast release aspirin tablets (1000 mg) + 2 x placebo acetaminophen caplets
Intervention Type
Drug
Intervention Name(s)
Acetaminophen + placebo
Intervention Description
Single dose, 2 x 500 mg Acetaminophen caplets (1000 mg) + 2 x placebo fast release Aspirin tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Single dose, 2 x placebo Acetaminophen caplets + 2 x placebo fast release Aspirin tablets
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
Time to first perceptible relief (defined as the time when the subject presses the first stopwatch)
Time Frame
Up to two hours
Title
Time weighted sum of pain intensity differences (PID) scores over first hour
Time Frame
Up to one hour
Title
Time weighted sum of pain intensity differences (PID) scores over 2 hours
Time Frame
Up to two hours
Title
Percentage difference from baseline Sore Throat Pain Intensity Scale (STPIS) to STPIS at time of meaningful relief
Time Frame
Up to two hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Storrs
State/Province
Connecticut
ZIP/Postal Code
06269-2011
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26603742
Citation
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.
Results Reference
derived
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Evaluate the Time of Pain Relief of Fast Acting Aspirin Versus Acetaminophen in Subjects Diagnosed With Sore Throat Pain
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