ToothachePhase 3NCT00720057

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

A Phase 3 study testing Naproxen Sodium ER (BAYH6689) in people with Toothache, run by Bayer at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 16 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Toothache
What is being tested?: Naproxen Sodium ER (BAYH6689)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 312 participants
Where: 3 sitesUnited States
Study dates: Jun 2008to Aug 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 to 45 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Study site
Austin, Texas, 78705
Study site
Austin, Texas, 78744
Study site
Salt Lake City, Utah, 84124

Other trials in United States

About this study

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

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
Being tested: Naproxen Sodium ER (BAYH6689), Placebo
Keywords: Dental Pain, Analgesia
Medical subject headings: Toothache, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT00720057
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 0 to 24 hours post dose

Secondary outcomes (5)

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.
Measured: 0-24 hours post dose
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.
Measured: 0-16 hours post dose
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.
Measured: postdose to first use of 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).
Measured: at 24 hours postdose or immediately before first use of rescue medication
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.
Measured: from postdose to onset of first perceptible and meaningful pain relief for up to 6 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2008Aug 2008

First posted22 Jul 2008 (estimated)
Study startJun 2008
Primary completionAug 2008
Study completionAug 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for ToothacheStudies of the same condition, open and under way.
More trials run by BayerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 312 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00720057
Sponsor's protocol ID: 13130
Other IDs: 2014-005269-66, 2014
Status last verified: Aug 2015
First submitted: 1 Jul 2008
Last updated: 25 Aug 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 26588111

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Toothache trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00720057
Acronym / sponsor ID: 13130
Conditions: Toothache
Keywords: Dental Pain, Analgesia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 312 participants (actual)
Lead sponsor: BayerIndustry (pharma, biotech, devices)
Study start: Jun 2008
Primary completion: Aug 2008 (actual)
Study completion: Aug 2008 (actual)
First posted: 22 Jul 2008 (estimated)
Results: Posted 25 Jan 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Naproxen sodium ER (BAYH6689)	Experimental	Drug: 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	Placebo comparator	Drug: PlaceboSingle dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.

Who may qualify

Ages: 16 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (5 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Naproxen Sodium ER (BAYH6689)Analgesic efficacy in dental pain; per oral; 1 tablet extended release Naproxen Sodium; with a full glass of water within 4 hours post surgery	Drug	Naproxen sodium ER (BAYH6689)
PlaceboInactive ingredient; per oral; 1 lactose based tablet; with a full glass of water within 4 hours post surgery	Drug	Placebo

Primary outcome

Summed Pain Intensity Difference (SPID)
Time frame: 0 to 24 hours post dose
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.

5 secondary outcomes

Total Pain Relief (TOTPAR)
Time frame: 0-24 hours post dose
Summed Pain Intensity Difference at Specific Time Intervals
Time frame: 0-16 hours post dose
Time to First Use of Rescue Medication
Time frame: postdose to first use of rescue medication
Global Assessment of the Investigational Product as a Pain Reliever
Time frame: at 24 hours postdose or immediately before first use of rescue medication
Time to Onset of Effect
Time frame: from postdose to onset of first perceptible and meaningful pain relief for up to 6 hours

Results and safety

Results posted to the registry on 25 Jan 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Naproxen Sodium ER (BAYH6689)	153	152
Placebo	159	156

Primary outcome: Summed Pain Intensity Difference (SPID)

Time frame: 0 to 24 hours post dose. Mean (Standard Deviation). Unit: units on a scale

Measure	Naproxen Sodium ER (BAYH6689) n = 153	Placebo n = 159
SPID 0-24	25.9 (25.87)	-3.1 (18.40)
SPID16-24	8.8 (9.30)	-1.0 (6.89)

Naproxen Sodium ER (BAYH6689) vs Placebo: p <0.001, ANCOVA

Population analysed: 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).

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Naproxen Sodium ER (BAYH6689)	0 of 153 (0%)	10 of 153 (6.5%)	Not reported
Placebo	0 of 159 (0%)	36 of 159 (22.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26588111Laurora 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.
Click here to find information about studies related to Bayer Healthcare products conducted in EuropeLink provided by the sponsor.

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Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bayer Study Director study director

Bayer

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Naproxen Sodium ER (BAYH6689) in people with Toothache, run by Bayer at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jan 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Summed Pain Intensity Difference (SPID) (time frame: 0 to 24 hours post dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00720057, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2015.