Evaluate Analgesic Efficacy of Fast Release Aspirin

NCT ID: NCT01122602

Last Updated: 2018-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-29
• Study Completion Date: 2010-08-06

Brief Summary

The objective of the study is to evaluate the analgesic efficacy of a single, oral dose of fast release aspirin tablets, 650 mg (2 x 325 mg) compared to regular aspirin tablets, 650 mg (2 x 325 mg) and placebo in subjects with postsurgical dental pain.

Conditions

Drugs, Investigational

Keywords

Aspirin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arm 1

Group Type: EXPERIMENTAL

Acetylsalicyclic acid (Fast acting Aspirin, BAY1019036)

Intervention Type: DRUG

Single dose of fast acting aspirin 2 x 325 mg = 650 mg total

Arm 2

Group Type: ACTIVE_COMPARATOR

Acetylsalicyclic acid (Aspirin, BAYE4465)

Intervention Type: DRUG

Single dose of regular aspirin 2 x 325 mg = 650 mg total

Arm 3

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Two placebo tablets

Interventions

Acetylsalicyclic acid (Fast acting Aspirin, BAY1019036)

Single dose of fast acting aspirin 2 x 325 mg = 650 mg total

Intervention Type: DRUG

Acetylsalicyclic acid (Aspirin, BAYE4465)

Single dose of regular aspirin 2 x 325 mg = 650 mg total

Intervention Type: DRUG

Placebo

Two placebo tablets

Intervention Type: DRUG

Eligibility Criteria

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, NSAIDs (Nonsteroidal Anti-inflammatory Drugs), 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 NSAIDs (Nonsteroidal Antiinflammatory Drugs), 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 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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Austin, Texas, United States

Salt Lake City, Utah, United States

Countries

United States

Related Links

http://www.clinicaltrialsregister.eu/

Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Other Identifiers

2014-005278-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

15082

Identifier Type: -

Identifier Source: org_study_id