Assessing the Analgesic Efficacy of Naproxen Sodium in Postsurgical Dental Pain.

NCT00720057 | Completed Phase 3 Results

• 2 other identifiers: 131302014-005269-66
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 3

Brief Summary

To evaluate the analgesic efficacy of a single, oral dose of a naproxen sodium extended-release tablet, compared to placebo in postsurgical dental pain.

Conditions

Toothache

Keywords

Dental Pain; Analgesia

Outcome Measures

Primary Outcomes (1)

• Summed Pain Intensity Difference (SPID)

  Categorical pain intensity scale - no pain (0), mild pain (1), moderate pain (2), or severe pain (3) was used for all pain intensity assessments postdose. Time-weighted Sum Pain Intensity Difference (SPID) was calculated by multiplying the Pain Intensity Difference (PID) score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values over 0-24 and 16-24 hours, respectively.

  0 to 24 hours post dose

Secondary Outcomes (5)

• Total Pain Relief (TOTPAR)

  0-24 hours post dose

• Summed Pain Intensity Difference at Specific Time Intervals

  0-16 hours post dose

• Time to First Use of Rescue Medication

  postdose to first use of rescue medication

• Global Assessment of the Investigational Product as a Pain Reliever

  at 24 hours postdose or immediately before first use of rescue medication

• Time to Onset of Effect

  from postdose to onset of first perceptible and meaningful pain relief for up to 6 hours

Study Arms (2)

Naproxen sodium ER (BAYH6689)

EXPERIMENTAL

single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.

Drug: Naproxen Sodium ER (BAYH6689)

Placebo

PLACEBO COMPARATOR

Single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.

Drug: Placebo

Interventions

Naproxen Sodium ER (BAYH6689) DRUG

Analgesic efficacy in dental pain; per oral; 1 tablet extended release Naproxen Sodium; with a full glass of water within 4 hours post surgery

Naproxen sodium ER (BAYH6689)

Placebo DRUG

Inactive ingredient; per oral; 1 lactose based tablet; with a full glass of water within 4 hours post surgery

Placebo

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Healthy, ambulatory, male and female volunteers between 16 to 45
• Scheduled to undergo surgical removal of 1 - 2 impacted third molars, one of which must be at least a partial mandibular bony impaction
• No use of any analgesics, nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin, any other pain reliever (Over The Counter or prescription), or herbal supplements within 5 days of surgery
• Have moderate to severe postoperative pain on the Categorical Pain Intensity Scale (a score of at least 2 on a 4 point scale) and a score of \>/= 50 mm on the 100-mm visual analog Pain Severity Rating Scale

You may not qualify if:

• History of hypersensitivity to naproxen sodium, aspirin (ASA), other NSAIDs, opioid analgesics, and similar pharmacological agents or components of the investigational products, including the placebo
• 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
• 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)

Sponsors & Collaborators

• Bayer: lead

Study Sites (3)

Unknown Facility

Austin, Texas, 78705, United States

Location

Unknown Facility

Austin, Texas, 78744, United States

Location

Unknown Facility

Salt Lake City, Utah, 84124, United States

Location

Related Publications (1)

• Laurora I, An R. Efficacy of single-dose, extended-release naproxen sodium 660 mg in postsurgical dental pain: two double-blind, randomized, placebo-controlled trials. Curr Med Res Opin. 2016;32(2):331-42. doi: 10.1185/03007995.2015.1123680. Epub 2015 Dec 15.

  PMID: 26588111 DERIVED

Related Links

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

MeSH Terms

Conditions

Toothache; Agnosia

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: BAYER

clinical-trials-contact@bayerhealthcare.com

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: July 1, 2008
• First Posted: July 22, 2008
• Study Start: June 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: August 25, 2015
• Results First Posted: January 25, 2011

Record last verified: 2015-08

Locations

US (3)