Study Completed

Drugs, Investigational

Bayer Identifier:

15120

ClinicalTrials.gov Identifier:

NCT01117636

EudraCT Number:

2014-005271-81

EU CT Number:

Not Available

Evaluate analgesic efficacy of fast release Aspirin

Trial purpose

The objective of the study is to evaluate the analgesic efficacy of a single, oral dose of fast release aspirin tablets, 1000 mg (2 x 500 mg) compared to regular aspirin tablets, 1000 mg (2 x 500 mg) and placebo in subjects with postsurgical dental pain.

Key Participants Requirements

Sex

Both

Age

16 - 45 Years

Inclusion Criteria
- Healthy, ambulatory, male and female volunteers between 16 to 45 years of age
- Scheduled to undergo surgical removal of either two partial bony impactions or one full bony alone or in combination with a partial bony impaction, soft tissue impaction or erupted third molar. Maxillary third molars may be removed regardless of impaction level
- Use of only short-acting local anesthetic (e.g., mepivacaine or lidocaine) preoperatively, with or without vasoconstrictor and nitrous oxide
- No use of any analgesics, nonsteroidal anti-inflammatory drug (NSAIDs), aspirin, any other pain reliever over the counter (OTC ) or prescription, or herbal supplements within 5 days of surgery. Oral contraceptives, prophylactic antibiotics, pre-anesthetic medication, anesthesia during the procedure, or other routine medications to treat benign conditions that would not confound the evaluation of the investigational would be acceptable.
- Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 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 and prior to surgery. Female subjects of nonchildbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy
- Provide a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the trial, (subjects < 18 years of age must sign a written assent and have parental or guardian consent)
Exclusion Criteria
- History of hypersensitivity to aspirin, salicylates, other nonsteroidal anti-inflammatory drug (NSAIDs), acetaminophen, opioid analgesics, and similar pharmacological agents or components of the investigational products, including the placebo
- Lactose intolerance or have had hypersensitivity reactions to lactose containing products
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases, or malignancies
- Relevant concomitant disease such as asthma (exercise induced asthma is permitted), chronic sinusitis or nasal structural abnormalities causing greater than 50 percent obstruction (polyposis nasi, marked septal deviation) that can interfere with the conduct of the study in the judgment of the Investigator
- Current or past history of bleeding disorder(s)
- History of gastrointestinal bleeding or perforation, related to previous nonsteroidal anti-inflammatory drug (NSAID) therapy. Active, or history of recurrent peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding)
- Acute illness or local infection prior to surgery that can interfere with the conduct of the study in the judgment of the Investigator
- Females who are pregnant or lactating
- Positive alcohol breathalyzer test and positive urine drug test prior to surgery

Trial summary

Enrollment Goal

514

Trial Dates

April 2010 - July 2010

Phase

Phase 3

Could I Receive a placebo

Yes

Products

Bayer Advanced Aspirin (Acetylsalicylic acid, BAY1019036)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Austin, 78744, United States
Completed		Salt Lake City, 84106, United States

Primary Outcome

Time to First Perceptible Pain Relief (PR)
Time Frame:
0 to 6 hours
Safety Issue:
no
Time to First Perceptible Pain Relief (PR) Confirmed
Time Frame:
0 to 6 hours
Safety Issue:
No

Secondary Outcome

Time to Meaningful Pain Relief (PR)
Time Frame:
0 to 6 hours
Safety Issue:
no
Pain Intensity at 10, 20, 30, 40, 50, and 60 Minutes and at 2, 3, 4, 5, and 6 Hours After Dosing
Pain Intensity (PI) was rated by subjects on a 4-point Categorical Pain Intensity Scale (0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain) for all pain intensity assessments post-dose.
Time Frame:
10, 20, 30, 40, and 50 minutes and at 1, 2, 3, 4, 5, and 6 hours postdose
Safety Issue:
no
Pain Intensity Difference (PID) at 10, 20, 30, 40, 50, and 60 Minutes and at 2, 3, 4, 5, and 6 Hours After Dosing
Pain intensity was evaluated using a 4-point Categorical Pain Intensity Rating Scale (0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain) for all pain intensity assessments post-dose. For each post-dose time point, PID was derived by subtracting the pain intensity at the post-dose time point from the baseline intensity score (baseline score – post-baseline score). A positive difference was indicative of improvement.
Time Frame:
10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours postdose
Safety Issue:
no
Pain Relief at 10, 20, 30, 40, 50, and 60 Minutes and at 2, 3, 4, 5, and 6 Hours After Dosing
Pain relief was rated by subjects using a 5-point Categorical Relief Rating Scale (0 = no relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief).
Time Frame:
10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours postdose
Safety Issue:
No
Summed Pain Intensity Differences (SPID) From Hour 0 Through Hour 2, Hour 4 and Hour 6
Time Frame:
0 to 6 hours postdose
Safety Issue:
No
Summed Total Pain Relief (TOTPAR) From Hour 0 Through Hour 2, Hour 4 and Hour 6
Time Frame:
0-6 hours post-dose
Safety Issue:
No
Time to First use of Rescue Medication
Time Frame:
0 to 6 hours
Safety Issue:
No
Cumulative Percentage of Subjects Taking Rescue Medication
Time Frame:
1, 2, 3, 4, 5, and 6 hours postdose
Safety Issue:
No
Global Assessment of the Investigational Product as a Pain Reliever at 6 Hours After Dosing or Immediately Before the First Intake of Rescue Medication
Time Frame:
At 6 hours postdose or immediately before first use of rescue medication
Safety Issue:
No

Trial design

A Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Trial Assessing the Analgesic Efficacy of a Single, Oral Dose of a Fast Release Aspirin 1000 mg in Postsurgical Dental Pain

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Randomized

Blinding

Double Blind

Assignment

Crossover Assignment

Trial Arms

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer Healthcare products.Click here to find information about studies related to Bayer Healthcare products conducted in Europe