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

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Naproxen Sodium ER (BAYH6689)

Placebo

About this trial

This is an interventional treatment trial for Toothache focused on measuring Dental Pain, Analgesia

Eligibility Criteria

16 Years - 45 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Naproxen sodium ER (BAYH6689)

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Total Pain Relief (TOTPAR)

Pain relief categorical rating scale - no relief (0), a little relief (1), some relief (2), a lot of relief (3), or complete relief (4) was used for all pain relief assessments postdose. Time weighted total pain relief (TOTPAR) was calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values.

Summed Pain Intensity Difference at Specific Time Intervals

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 for 0-6, 0-12, 0-16 hour intervals, respectively.

Time to First Use of Rescue Medication

Time to first use of rescue medication was estimated using the Kaplan-Meier method and analyzed by a Log rank test stratified by trial site and baseline pain intensity (PI). The outcome measure is time to first use of rescue medication. The criteria are if adequate pain relief is not achieved, then subjects are permitted to take rescue medication.

Global Assessment of the Investigational Product as a Pain Reliever

Categorical Scale: Poor (0), Fair (1), Good (2), Very Good (3), Excellent (4).

Time to Onset of Effect

Time to onset of effect is defined as the time to meaningful pain relief, provided that the subjects experienced both "perceptible" and "meaningful" pain relief. Perceptible pain relief was defined as when the subject first began to feel any pain-relieving effect from the investigational product. Meaningful pain relief was defined as when the subject felt the degree of pain relief was meaningful to them.

Full Information

NCT ID

NCT00720057

First Posted

July 1, 2008

Last Updated

August 12, 2015

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT00720057

Brief Title

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

Official Title

A Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Trial Assessing the Analgesic Efficacy of a Single, Oral Dose of an Extended Release Naproxen Sodium Tablet in Postsurgical Dental Pain

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Completed

Study Start Date

June 2008 (undefined)

Primary Completion Date

August 2008 (Actual)

Study Completion Date

August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Toothache

Keywords

Dental Pain, Analgesia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

312 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Naproxen sodium ER (BAYH6689)

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Naproxen Sodium ER (BAYH6689)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Summed Pain Intensity Difference (SPID)

Description

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.

Time Frame

0 to 24 hours post dose

Secondary Outcome Measure Information:

Title

Total Pain Relief (TOTPAR)

Description

Pain relief categorical rating scale - no relief (0), a little relief (1), some relief (2), a lot of relief (3), or complete relief (4) was used for all pain relief assessments postdose. Time weighted total pain relief (TOTPAR) was calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values.

Time Frame

0-24 hours post dose

Title

Summed Pain Intensity Difference at Specific Time Intervals

Description

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 for 0-6, 0-12, 0-16 hour intervals, respectively.

Time Frame

0-16 hours post dose

Title

Time to First Use of Rescue Medication

Description

Time to first use of rescue medication was estimated using the Kaplan-Meier method and analyzed by a Log rank test stratified by trial site and baseline pain intensity (PI). The outcome measure is time to first use of rescue medication. The criteria are if adequate pain relief is not achieved, then subjects are permitted to take rescue medication.

Time Frame

postdose to first use of rescue medication

Title

Global Assessment of the Investigational Product as a Pain Reliever

Description

Categorical Scale: Poor (0), Fair (1), Good (2), Very Good (3), Excellent (4).

Time Frame

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

Title

Time to Onset of Effect

Description

Time to onset of effect is defined as the time to meaningful pain relief, provided that the subjects experienced both "perceptible" and "meaningful" pain relief. Perceptible pain relief was defined as when the subject first began to feel any pain-relieving effect from the investigational product. Meaningful pain relief was defined as when the subject felt the degree of pain relief was meaningful to them.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Austin

State/Province

Texas

ZIP/Postal Code

78705

Country

United States

City

Austin

State/Province

Texas

ZIP/Postal Code

78744

Country

United States

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84124

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

26588111

Citation

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. Erratum In: Curr Med Res Opin. 2016;32(3):611.

Results Reference

derived

Links:

URL

http://www.clinicaltrialsregister.eu/

Description

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

Toothache

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial