Evaluate Analgesic Efficacy of Fast Release Aspirin

NCT01117636 | Completed Phase 3

• 2 other identifiers: 151202014-005271-81
• Study Type: interventional
• Target: 514
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Drugs, Investigational

Keywords

Aspirin

Outcome Measures

Primary Outcomes (2)

• Time to First Perceptible Pain Relief (PR)

  0 to 6 hours

• Time to First Perceptible Pain Relief (PR) Confirmed

  0 to 6 hours

Secondary Outcomes (9)

• Time to Meaningful Pain Relief (PR)

  0 to 6 hours

• Pain Intensity at 10, 20, 30, 40, 50, and 60 Minutes and at 2, 3, 4, 5, and 6 Hours After Dosing

  10, 20, 30, 40, and 50 minutes and at 1, 2, 3, 4, 5, and 6 hours postdose

• Pain Intensity Difference (PID) at 10, 20, 30, 40, 50, and 60 Minutes and at 2, 3, 4, 5, and 6 Hours After Dosing

  10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours postdose

• Pain Relief at 10, 20, 30, 40, 50, and 60 Minutes and at 2, 3, 4, 5, and 6 Hours After Dosing

  10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours postdose

• Summed Pain Intensity Differences (SPID) From Hour 0 Through Hour 2, Hour 4 and Hour 6

  0 to 6 hours postdose

Study Arms (3)

Arm 1

EXPERIMENTAL

Drug: Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Arm 2

ACTIVE COMPARATOR

Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)

Arm 3

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Acetylsalicylic acid (Fast release Aspirin, BAY1019036) DRUG

Single oral dose of fast release aspirin tablets 1000 mg (2 x 500 mg) with a full glass of water (240 milliliter \[mL\]) between 14 hours post dental surgery.

Arm 1

Acetylsalicylic Acid (Aspirin, BAYE4465) DRUG

Single oral dose of regular aspirin tablet 1000 mg (2 x 500 mg) with a full glass of water (240 mL) between 14 hours post dental surgery.

Arm 2

Placebo DRUG

Single oral dose of 2 placebo tablets with a full glass of water (240 mL) between 14 hours post dental surgery.

Arm 3

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (2)

Unknown Facility

Austin, Texas, 78744, United States

Location

Unknown Facility

Salt Lake City, Utah, 84106, United States

Location

Related Links

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

MeSH Terms

Interventions

Aspirin

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2010
• First Posted: May 5, 2010
• Study Start: April 28, 2010
• Primary Completion: July 7, 2010
• Study Completion: July 7, 2010
• Last Updated: December 19, 2018

Record last verified: 2018-12

Locations

US (2)