Trial · NCT01280591

Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine in Patients With Postsurgical Dental Pain

NCT01280591, Phase 3, Completed, Bayer; results first posted 2014-06-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine in Patients With Postsurgical Dental Pain. Trials, record NCT01280591. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01280591

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine in Patients With Postsurgical Dental Pain
NCT number: NCT01280591
Status: Completed
Phases: Phase 3
Enrollment: 712 participants, actual
Lead sponsor: Bayer
Conditions: Pain, Postoperative
Interventions: Naproxen sodium 440 mg / DPH 50 mg (BAY98-7111), Naproxen sodium 220 mg / DPH 50 mg (BAY98-7111), Naproxen sodium 440 mg (BAYH6689), DPH 50 mg
First posted: 2011-01-21
Last updated: 2015-06-08
Results first posted: 2014-06-17

Source ClinicalTrials.gov

Registered outcomes21

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Wake Time After Sleep Onset (WASO) Measured by Actigraphy	Up to 10 hours	WASO was defined as Total wake time (in minutes) after sleep onset during the 10 hours in-bed period as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.
Primary	Sleep Latency Measured by Actigraphy	Up to 10 hours	Sleep latency was defined as the time to sleep onset from the time of dosing as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.
Secondary	Total Sleep Time Measured by Actigraphy	Up to 10 hours	Total time time was measured as total time spent sleeping (not to exceed 600 minutes) during the in-bed period as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.
Secondary	Sleep Efficiency Measured by Actigraphy	Up to 10 hours	Sleep efficiency was calculated as (total sleep time/total time in-bed time) × 100; total in-bed time was fixed at 10 hours. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.
Secondary	Global Assessment of Investigational Product as a Sleep Aid	Up to 10 hours	The Global Assessment of Investigational Product as a Sleep-Aid was rated using a 5-point categorical scale for which the potential response was poor (0), fair, (1), good (2), very good (3), or excellent (4).
Secondary	Karolinska Sleep Diary - Sleep Quality	Up to 10 hours	Subjects responded to the following question: How was your sleep? very poor (1); rather poor (2); neither poor nor good (3); rather good (4); very good (5)
Secondary	Karolinska Sleep Diary - Calmness of Sleep	Up to 10 hours	Subjects responded to the following question: How calm was your sleep? very restless (1); rather restless (2); neither restless nor calm (3); rather calm (4); very calm (5)
Secondary	Karolinska Sleep Diary - Easiness to Fall Asleep	Up to 10 hours	Subjects responded to the following question: How easy was it to fall asleep? very difficult (1); rather difficult (2); neither difficult nor easy (3); rather easy (4); very easy (5)
Secondary	Karolinska Sleep Diary - Premature Awakening	Up to 10 hours	Subjects responded to the following question: Premature awakening? woke up much too early (1); woke up somewhat too early (2); no (3)
Secondary	Karolinska Sleep Diary - Ease of Awakening	Up to 10 hours	Subjects responded to the following question: Ease of awakening? (1) very difficult; (2) rather difficult; (3) neither difficult nor easy; (4) rather easy; very easy (5)

1 to 10 of 21Source ClinicalTrials.gov

See all 21 registered outcomes

Outcomes21

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Wake Time After Sleep Onset (WASO) Measured by Actigraphy	Up to 10 hours	ITT (Intent to Treat) Population	Minutes	LEAST_SQUARES_MEAN
PRIMARY	Sleep Latency Measured by Actigraphy	Up to 10 hours	ITT (Intent to Treat) Population	Minutes	MEDIAN
SECONDARY	Total Sleep Time Measured by Actigraphy	Up to 10 hours	ITT (Intent to Treat) Population	Minutes	LEAST_SQUARES_MEAN
SECONDARY	Sleep Efficiency Measured by Actigraphy	Up to 10 hours	ITT (Intent to Treat) Population	Percent of sleep time during in-bed time	LEAST_SQUARES_MEAN
SECONDARY	Global Assessment of Investigational Product as a Sleep Aid	Up to 10 hours	ITT (Intent to Treat) Population with available data (missing values were not imputed)	Participants	NUMBER
SECONDARY	Karolinska Sleep Diary - Sleep Quality	Up to 10 hours	ITT (Intent to Treat) Population with available data (missing values were not imputed)	Participants	NUMBER
SECONDARY	Karolinska Sleep Diary - Calmness of Sleep	Up to 10 hours	ITT (Intent to Treat) Population with available data (missing values were not imputed)	Participants	NUMBER
SECONDARY	Karolinska Sleep Diary - Easiness to Fall Asleep	Up to 10 hours	ITT (Intent to Treat) Population with available data (missing values were not imputed)	Participants	NUMBER
SECONDARY	Karolinska Sleep Diary - Premature Awakening	Up to 10 hours	ITT (Intent to Treat) Population with available data (missing values were not imputed)	Participants	NUMBER
SECONDARY	Karolinska Sleep Diary - Ease of Awakening	Up to 10 hours	ITT (Intent to Treat) Population with available data (missing values were not imputed)	Participants	NUMBER

1 to 10 of 21Source ClinicalTrials.gov

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Results by group264

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Wake Time After Sleep Onset (WASO) Measured by Actigraphy	Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)	143.7	95% Confidence Interval 117.9 to 169.6	Minutes
Wake Time After Sleep Onset (WASO) Measured by Actigraphy	Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)	230.9	95% Confidence Interval 205.2 to 256.5	Minutes
Wake Time After Sleep Onset (WASO) Measured by Actigraphy	Naproxen Sodium 440 mg (BAYH6689)	214.0	95% Confidence Interval 188.2 to 239.8	Minutes
Wake Time After Sleep Onset (WASO) Measured by Actigraphy	DPH 50 mg	431.4	95% Confidence Interval 395.1 to 467.6	Minutes
Sleep Latency Measured by Actigraphy	Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)	25.50	95% Confidence Interval 22.50 to 30.00	Minutes
Sleep Latency Measured by Actigraphy	Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)	30.25	95% Confidence Interval 25.00 to 33.50	Minutes
Sleep Latency Measured by Actigraphy	Naproxen Sodium 440 mg (BAYH6689)	25.75	95% Confidence Interval 22.50 to 29.50	Minutes
Sleep Latency Measured by Actigraphy	DPH 50 mg	41.50	95% Confidence Interval 26.50 to 54.50	Minutes
Total Sleep Time Measured by Actigraphy	Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)	426.2	95% Confidence Interval 400.9 to 451.4	Minutes
Total Sleep Time Measured by Actigraphy	Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)	337.7	95% Confidence Interval 312.6 to 362.7	Minutes

1 to 10 of 264Source ClinicalTrials.gov

See all 264 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)	203
Overall Study	STARTED	Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)	204
Overall Study	STARTED	Naproxen Sodium 440 mg (BAYH6689)	203
Overall Study	STARTED	DPH 50 mg	102
Overall Study	COMPLETED	Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)	203
Overall Study	COMPLETED	Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)	204
Overall Study	COMPLETED	Naproxen Sodium 440 mg (BAYH6689)	203
Overall Study	COMPLETED	DPH 50 mg	99
Overall Study	NOT COMPLETED	Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)	0
Overall Study	NOT COMPLETED	Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)	0

1 to 10 of 12Source ClinicalTrials.gov

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Adverse events128

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Tachycardia	Cardiac disorders	Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)	0	203
other	Tachycardia	Cardiac disorders	Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)	1	204
other	Tachycardia	Cardiac disorders	Naproxen Sodium 440 mg (BAYH6689)	1	203
other	Tachycardia	Cardiac disorders	DPH 50 mg	0	102
other	Ear pain	Ear and labyrinth disorders	Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)	0	203
other	Ear pain	Ear and labyrinth disorders	Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)	0	204
other	Ear pain	Ear and labyrinth disorders	Naproxen Sodium 440 mg (BAYH6689)	0	203
other	Ear pain	Ear and labyrinth disorders	DPH 50 mg	1	102
other	Constipation	Gastrointestinal disorders	Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)	0	203
other	Constipation	Gastrointestinal disorders	Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)	0	204

1 to 10 of 128Source ClinicalTrials.gov

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Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)
Total, all-cause mortality	Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)
Total, all-cause mortality	Naproxen Sodium 440 mg (BAYH6689)
Total, all-cause mortality	DPH 50 mg
Total, other adverse events	Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)	37	203
Total, other adverse events	Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)	37	204
Total, other adverse events	Naproxen Sodium 440 mg (BAYH6689)	40	203
Total, other adverse events	DPH 50 mg	25	102
Total, serious adverse events	Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)	0	203
Total, serious adverse events	Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)	0	204

1 to 10 of 12Source ClinicalTrials.gov

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Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
25996289	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01280591

GET https://conductscience.org/api/trials/v1/NCT01280591/registered?page=2

API reference For AI assistants