Trial Outcomes & Findings for Assessing the Analgesic Efficacy of Naproxen Sodium in Postsurgical Dental Pain. (NCT NCT00720057)

NCT ID: NCT00720057

Last Updated: 2015-08-25

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

312 participants

Primary outcome timeframe

0 to 24 hours post dose

Results posted on

2015-08-25

Participant Flow

The Screening Period occurred up to 28 days prior to the day of dental surgery. A total of 447 subjects were screened, of which 135 were excluded (72 did not meet inclusion criteria, 19 refused to participate, 44 other reasons); 312 subjects were randomized and included in the intent-to-treat (ITT) population for efficacy and safety analysis.

Participant milestones

Participant milestones
Measure	Naproxen Sodium ER (BAYH6689) single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.	Placebo single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
Overall Study STARTED	153	159
Overall Study COMPLETED	152	156
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Naproxen Sodium ER (BAYH6689) single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.	Placebo single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
Overall Study Lost to Follow-up	0	2
Overall Study Protocol Violation	1	0
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Naproxen Sodium ER (BAYH6689) n=153 Participants single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.	Placebo n=159 Participants single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.	Total n=312 Participants Total of all reporting groups
Age, Continuous	20.8 years STANDARD_DEVIATION 4.03 • n=5 Participants	20.4 years STANDARD_DEVIATION 4.31 • n=7 Participants	20.6 years STANDARD_DEVIATION 4.17 • n=5 Participants
Sex: Female, Male Female	89 Participants n=5 Participants	106 Participants n=7 Participants	195 Participants n=5 Participants
Sex: Female, Male Male	64 Participants n=5 Participants	53 Participants n=7 Participants	117 Participants n=5 Participants
Baseline Pain Intensity by Categorical Scale Moderate	99 participants n=5 Participants	103 participants n=7 Participants	202 participants n=5 Participants
Baseline Pain Intensity by Categorical Scale Severe	54 participants n=5 Participants	56 participants n=7 Participants	110 participants n=5 Participants
Baseline Pain Intensity by Visual Analog Scale	72.3 scores on a scale STANDARD_DEVIATION 13.13 • n=5 Participants	72.6 scores on a scale STANDARD_DEVIATION 11.91 • n=7 Participants	72.4 scores on a scale STANDARD_DEVIATION 12.51 • n=5 Participants

PRIMARY outcome

Timeframe: 0 to 24 hours post dose

Population: Randomized population is defined as all subjects who signed informed consent form, completed the screening period, and were randomized. The ITT population is defined as all subjects who were randomized and received at least one dose of the study treatment. Efficacy analyses are based on the ITT population (n=312).

Outcome measures

Outcome measures
Measure	Naproxen Sodium ER (BAYH6689) n=153 Participants single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.	Placebo n=159 Participants single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
Summed Pain Intensity Difference (SPID) SPID 0-24	25.9 units on a scale Standard Deviation 25.87	-3.1 units on a scale Standard Deviation 18.40
Summed Pain Intensity Difference (SPID) SPID16-24	8.8 units on a scale Standard Deviation 9.30	-1.0 units on a scale Standard Deviation 6.89

SECONDARY outcome

Timeframe: 0-24 hours post dose

Population: Efficacy analyses were based on ITT population (n=312).

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.

Outcome measures

Outcome measures
Measure	Naproxen Sodium ER (BAYH6689) n=153 Participants single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.	Placebo n=159 Participants single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
Total Pain Relief (TOTPAR) TOTPAR 0 - 6 hours	12.7 units on a scale Standard Deviation 7.81	3.1 units on a scale Standard Deviation 5.07
Total Pain Relief (TOTPAR) TOTPAR 0 - 12 hours	25.5 units on a scale Standard Deviation 17.06	5.5 units on a scale Standard Deviation 10.70
Total Pain Relief (TOTPAR) TOTPAR 0 - 16 hours	34.1 units on a scale Standard Deviation 23.49	7.2 units on a scale Standard Deviation 14.83
Total Pain Relief (TOTPAR) TOTPAR 0 - 24 hours	51.3 units on a scale Standard Deviation 36.41	10.9 units on a scale Standard Deviation 23.95
Total Pain Relief (TOTPAR) TOTPAR 16 - 24 hours	17.2 units on a scale Standard Deviation 13.37	3.7 units on a scale Standard Deviation 9.40

SECONDARY outcome

Timeframe: 0-16 hours post dose

Population: Efficacy analyses were based on ITT population (n=312).

Outcome measures

Outcome measures
Measure	Naproxen Sodium ER (BAYH6689) n=153 Participants single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.	Placebo n=159 Participants single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
Summed Pain Intensity Difference at Specific Time Intervals SPID 0 - 6	6.2 units on a scale Standard Deviation 5.7	-0.4 units on a scale Standard Deviation 4.2
Summed Pain Intensity Difference at Specific Time Intervals SIPD 0 - 12	12.7 units on a scale Standard Deviation 12.3	-1.4 units on a scale Standard Deviation 8.54
Summed Pain Intensity Difference at Specific Time Intervals SIPD 0 - 16	17.1 units on a scale Standard Deviation 16.85	-2.0 units on a scale Standard Deviation 11.68

SECONDARY outcome

Timeframe: postdose to first use of rescue medication

Population: Efficacy analyses are based on ITT population (n=312).

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.

Outcome measures

Outcome measures
Measure	Naproxen Sodium ER (BAYH6689) n=153 Participants single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.	Placebo n=159 Participants single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
Time to First Use of Rescue Medication	22.27 hours Interval 1.07 to 22.27	1.90 hours Interval 1.03 to 10.12

SECONDARY outcome

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

Population: Efficacy analyses are based on ITT population (n=312).

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

Outcome measures

Outcome measures
Measure	Naproxen Sodium ER (BAYH6689) n=153 Participants single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.	Placebo n=159 Participants single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
Global Assessment of the Investigational Product as a Pain Reliever	2.3 units on a scale Standard Deviation 1.43	0.6 units on a scale Standard Deviation 1.04

SECONDARY outcome

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

Population: Efficacy analyses are based on ITT population (n=312).

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.

Outcome measures

Outcome measures
Measure	Naproxen Sodium ER (BAYH6689) n=153 Participants single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.	Placebo n=159 Participants single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
Time to Onset of Effect	1.37 hours Interval 0.07 to 4.98	4.13 hours Interval 0.07 to 4.75

Adverse Events

Naproxen Sodium ER (BAYH6689)

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 36 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Therapeutic Area Head

BAYER

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Naproxen Sodium ER (BAYH6689) n=153 participants at risk single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.	Placebo n=159 participants at risk single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
Ear and labyrinth disorders Tinnitus	0.00% 0/153 • Adverse events were recorded throughout the treatment period through 5 days after investigational product or placebo administration. All Serious Adverse Events were collected through about 30 days after the last dose of investigational product or placebo.	0.63% 1/159 • Number of events 1 • Adverse events were recorded throughout the treatment period through 5 days after investigational product or placebo administration. All Serious Adverse Events were collected through about 30 days after the last dose of investigational product or placebo.
Eye disorders Conjunctivitis	0.00% 0/153 • Adverse events were recorded throughout the treatment period through 5 days after investigational product or placebo administration. All Serious Adverse Events were collected through about 30 days after the last dose of investigational product or placebo.	0.63% 1/159 • Number of events 2 • Adverse events were recorded throughout the treatment period through 5 days after investigational product or placebo administration. All Serious Adverse Events were collected through about 30 days after the last dose of investigational product or placebo.
Eye disorders Eye Swelling	0.65% 1/153 • Number of events 1 • Adverse events were recorded throughout the treatment period through 5 days after investigational product or placebo administration. All Serious Adverse Events were collected through about 30 days after the last dose of investigational product or placebo.	0.00% 0/159 • Adverse events were recorded throughout the treatment period through 5 days after investigational product or placebo administration. All Serious Adverse Events were collected through about 30 days after the last dose of investigational product or placebo.
Eye disorders Scotoma	0.00% 0/153 • Adverse events were recorded throughout the treatment period through 5 days after investigational product or placebo administration. All Serious Adverse Events were collected through about 30 days after the last dose of investigational product or placebo.	0.63% 1/159 • Number of events 1 • Adverse events were recorded throughout the treatment period through 5 days after investigational product or placebo administration. All Serious Adverse Events were collected through about 30 days after the last dose of investigational product or placebo.
Gastrointestinal disorders Abdominal Pain	0.00% 0/153 • Adverse events were recorded throughout the treatment period through 5 days after investigational product or placebo administration. All Serious Adverse Events were collected through about 30 days after the last dose of investigational product or placebo.	0.63% 1/159 • Number of events 1 • Adverse events were recorded throughout the treatment period through 5 days after investigational product or placebo administration. All Serious Adverse Events were collected through about 30 days after the last dose of investigational product or placebo.
Gastrointestinal disorders Dyspepsia	0.00% 0/153 • Adverse events were recorded throughout the treatment period through 5 days after investigational product or placebo administration. All Serious Adverse Events were collected through about 30 days after the last dose of investigational product or placebo.	0.63% 1/159 • Number of events 1 • Adverse events were recorded throughout the treatment period through 5 days after investigational product or placebo administration. All Serious Adverse Events were collected through about 30 days after the last dose of investigational product or placebo.
Gastrointestinal disorders Nausea	2.0% 3/153 • Number of events 3 • Adverse events were recorded throughout the treatment period through 5 days after investigational product or placebo administration. All Serious Adverse Events were collected through about 30 days after the last dose of investigational product or placebo.	15.1% 24/159 • Number of events 24 • Adverse events were recorded throughout the treatment period through 5 days after investigational product or placebo administration. All Serious Adverse Events were collected through about 30 days after the last dose of investigational product or placebo.
Gastrointestinal disorders Stomach Discomfort	0.00% 0/153 • Adverse events were recorded throughout the treatment period through 5 days after investigational product or placebo administration. All Serious Adverse Events were collected through about 30 days after the last dose of investigational product or placebo.	0.63% 1/159 • Number of events 1 • Adverse events were recorded throughout the treatment period through 5 days after investigational product or placebo administration. All Serious Adverse Events were collected through about 30 days after the last dose of investigational product or placebo.
Gastrointestinal disorders Tooth Socket Haemorrhage	0.65% 1/153 • Number of events 1 • Adverse events were recorded throughout the treatment period through 5 days after investigational product or placebo administration. All Serious Adverse Events were collected through about 30 days after the last dose of investigational product or placebo.	1.3% 2/159 • Number of events 2 • Adverse events were recorded throughout the treatment period through 5 days after investigational product or placebo administration. All Serious Adverse Events were collected through about 30 days after the last dose of investigational product or placebo.
Gastrointestinal disorders Vomiting	1.3% 2/153 • Number of events 2 • Adverse events were recorded throughout the treatment period through 5 days after investigational product or placebo administration. All Serious Adverse Events were collected through about 30 days after the last dose of investigational product or placebo.	8.8% 14/159 • Number of events 14 • Adverse events were recorded throughout the treatment period through 5 days after investigational product or placebo administration. All Serious Adverse Events were collected through about 30 days after the last dose of investigational product or placebo.
General disorders Pyrexia	0.65% 1/153 • Number of events 1 • Adverse events were recorded throughout the treatment period through 5 days after investigational product or placebo administration. All Serious Adverse Events were collected through about 30 days after the last dose of investigational product or placebo.	0.00% 0/159 • Adverse events were recorded throughout the treatment period through 5 days after investigational product or placebo administration. All Serious Adverse Events were collected through about 30 days after the last dose of investigational product or placebo.
Infections and infestations Abscess Oral	0.65% 1/153 • Number of events 1 • Adverse events were recorded throughout the treatment period through 5 days after investigational product or placebo administration. All Serious Adverse Events were collected through about 30 days after the last dose of investigational product or placebo.	0.00% 0/159 • Adverse events were recorded throughout the treatment period through 5 days after investigational product or placebo administration. All Serious Adverse Events were collected through about 30 days after the last dose of investigational product or placebo.
Infections and infestations Tooth Abscess	0.00% 0/153 • Adverse events were recorded throughout the treatment period through 5 days after investigational product or placebo administration. All Serious Adverse Events were collected through about 30 days after the last dose of investigational product or placebo.	0.63% 1/159 • Number of events 1 • Adverse events were recorded throughout the treatment period through 5 days after investigational product or placebo administration. All Serious Adverse Events were collected through about 30 days after the last dose of investigational product or placebo.
Injury, poisoning and procedural complications Post Procedural Haemorrhage	0.00% 0/153 • Adverse events were recorded throughout the treatment period through 5 days after investigational product or placebo administration. All Serious Adverse Events were collected through about 30 days after the last dose of investigational product or placebo.	0.63% 1/159 • Number of events 1 • Adverse events were recorded throughout the treatment period through 5 days after investigational product or placebo administration. All Serious Adverse Events were collected through about 30 days after the last dose of investigational product or placebo.
Nervous system disorders Dizziness	0.65% 1/153 • Number of events 1 • Adverse events were recorded throughout the treatment period through 5 days after investigational product or placebo administration. All Serious Adverse Events were collected through about 30 days after the last dose of investigational product or placebo.	5.0% 8/159 • Number of events 8 • Adverse events were recorded throughout the treatment period through 5 days after investigational product or placebo administration. All Serious Adverse Events were collected through about 30 days after the last dose of investigational product or placebo.
Nervous system disorders Headache	3.3% 5/153 • Number of events 5 • Adverse events were recorded throughout the treatment period through 5 days after investigational product or placebo administration. All Serious Adverse Events were collected through about 30 days after the last dose of investigational product or placebo.	3.8% 6/159 • Number of events 6 • Adverse events were recorded throughout the treatment period through 5 days after investigational product or placebo administration. All Serious Adverse Events were collected through about 30 days after the last dose of investigational product or placebo.
Nervous system disorders Syncope	0.65% 1/153 • Number of events 1 • Adverse events were recorded throughout the treatment period through 5 days after investigational product or placebo administration. All Serious Adverse Events were collected through about 30 days after the last dose of investigational product or placebo.	0.63% 1/159 • Number of events 1 • Adverse events were recorded throughout the treatment period through 5 days after investigational product or placebo administration. All Serious Adverse Events were collected through about 30 days after the last dose of investigational product or placebo.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal Pain	0.65% 1/153 • Number of events 1 • Adverse events were recorded throughout the treatment period through 5 days after investigational product or placebo administration. All Serious Adverse Events were collected through about 30 days after the last dose of investigational product or placebo.	0.00% 0/159 • Adverse events were recorded throughout the treatment period through 5 days after investigational product or placebo administration. All Serious Adverse Events were collected through about 30 days after the last dose of investigational product or placebo.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/153 • Adverse events were recorded throughout the treatment period through 5 days after investigational product or placebo administration. All Serious Adverse Events were collected through about 30 days after the last dose of investigational product or placebo.	0.63% 1/159 • Number of events 1 • Adverse events were recorded throughout the treatment period through 5 days after investigational product or placebo administration. All Serious Adverse Events were collected through about 30 days after the last dose of investigational product or placebo.
Vascular disorders Flushing	0.65% 1/153 • Number of events 1 • Adverse events were recorded throughout the treatment period through 5 days after investigational product or placebo administration. All Serious Adverse Events were collected through about 30 days after the last dose of investigational product or placebo.	0.00% 0/159 • Adverse events were recorded throughout the treatment period through 5 days after investigational product or placebo administration. All Serious Adverse Events were collected through about 30 days after the last dose of investigational product or placebo.