Dental PainPhase 2NCT01229228

Study of Naproxen Capsules to Treat Dental Pain

A Phase 2 study testing Naproxen Test and Naprosyn in people with Dental Pain, run by Iroko Pharmaceuticals, LLC at 1 site 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

The purpose of the study is to determine whether Naproxen Test Formulation Capsules are safe and effective for the treatment of dental pain. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Dental Pain
What is being tested?: Naproxen Test and Naprosyn
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 254 participants
Where: 1 siteUnited States
Study dates: Oct 2010to Apr 2011
Phase: Phase 2
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 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Patient is male or female between 18 and 50 years of age
For women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control
Patient requires extraction of 2 or more third molars
Patient must be willing to stay at the study site overnight

Who cannot join

Patient has hypersensitivity, allergy, or clinically significant intolerance to any medications to be used in the study, or related drugs
Patient has a current disease or history of a disease that will impact the study or the patient's well-being
Patient has used or intends to use any of the medications that are prohibited by the protocol
Patient has a history of drug or alcohol abuse or dependence, or patient has a positive urine drug screen or alcohol breathalyzer test
Patient has taken another investigational drug within 30 days prior to screening

Trial locations and contacts

1 site in 1 country.

United States1 site

Premier Research Group Limited
Austin, Texas, 78705

Other trials in United States

About this study

Official title: A Phase 2, Randomized, Double-Blind, Single-Dose, Parallel-Group, Active- and Placebo-Controlled Study of Naproxen [Test] Capsules for the Treatment of Pain After Surgical Removal of Impacted Third Molars

The purpose of the study is to determine whether Naproxen Test Formulation Capsules are safe and effective for the treatment of dental pain.

Conditions: Dental Pain
Being tested: Naproxen Test, Naprosyn, Placebo
Medical subject headings: Toothache

What participants receive

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

Naproxen TestDrug
200-mg single dose
Naproxen TestDrug
400-mg (2 x 200-mg)
NaprosynDrug
single dose
NaprosynDrug
single dose
PlaceboDrug
single dose

Study groups in NCT01229228
Study group	Role	What they receive
Naproxen Test (lower dose)	Experimental	200-mg Receives: Drug: Naproxen Test
Naproxen Test (upper dose)	Experimental	400-mg (2 x 200-mg) Receives: Drug: Naproxen Test
Naprosyn 250 mg	Active comparator	Not described Receives: Drug: Naprosyn
Naprosyn 500 mg	Active comparator	Not described Receives: Drug: Naprosyn
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

Analysis of Total Pain Relief (TOTPAR) Over 0 to 12 Hours (TOTPAR-12) After Time 0
Total pain relief as computed as a time-weighted sum of individual patient pain relief scores at each timepoint from 0-12 hours.
Values for TOTPAR are measured from 0 to 4 on the Pain Relief Scale 0 None Min; 1 A little; 2 Some; 3 A lot; 4 Complete Max
The TOTPAR is a weighted measure of the observations; the minimum possible value is 0 and the maximum possible value is 60.
Measured: Over 0 to 12 Hours

Timeline

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

Oct 2010Apr 2011

First posted27 Oct 2010 (estimated)
Study startOct 2010
Primary completionApr 2011
Study completionApr 2011

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 Dental PainStudies of the same condition, open and under way.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 254 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01229228
Sponsor's protocol ID: NAP2-08-03
Status last verified: Mar 2012
First submitted: 25 Oct 2010
Last updated: 22 May 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Young CL, Strand V, Altman R, Daniels S. A phase 2 study of naproxen submicron particle capsules in patients with post-surgical dental pain. Adv Ther. 2013 Oct;30(10):885-96. doi: 10.1007/s12325-013-0057-9. Epub 2013 Oct 15.
PubMed 24127200

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 Dental Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 22 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Randomized, Double-Blind, Single-Dose, Parallel-Group, Active- and Placebo-Controlled Study of Naproxen [Test] Capsules for the Treatment of Pain After Surgical Removal of Impacted Third Molars
ClinicalTrials.gov ID: NCT01229228
Acronym / sponsor ID: NAP2-08-03
Conditions: Dental Pain
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 254 participants (actual)
Lead sponsor: Iroko Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
Study start: Oct 2010
Primary completion: Apr 2011 (actual)
Study completion: Apr 2011 (actual)
First posted: 27 Oct 2010 (estimated)
Results: Posted 29 Mar 2012

Clinical summary

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

The purpose of the study is to determine whether Naproxen Test Formulation Capsules are safe and effective for the treatment of dental pain.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Naproxen Test (lower dose)	Experimental	Drug: Naproxen Test200-mg
Naproxen Test (upper dose)	Experimental	Drug: Naproxen Test400-mg (2 x 200-mg)
Naprosyn 250 mg	Active comparator	Drug: Naprosyn
Naprosyn 500 mg	Active comparator	Drug: Naprosyn
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Patient is male or female between 18 and 50 years of age
For women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control
Patient requires extraction of 2 or more third molars
Patient must be willing to stay at the study site overnight

Key exclusion criteria (5 listed)

Patient has hypersensitivity, allergy, or clinically significant intolerance to any medications to be used in the study, or related drugs
Patient has a current disease or history of a disease that will impact the study or the patient's well-being
Patient has used or intends to use any of the medications that are prohibited by the protocol
Patient has a history of drug or alcohol abuse or dependence, or patient has a positive urine drug screen or alcohol breathalyzer test
Patient has taken another investigational drug within 30 days prior to screening

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 Test200-mg single dose	Drug	Naproxen Test (lower dose)
Naproxen Test400-mg (2 x 200-mg)	Drug	Naproxen Test (upper dose)
Naprosynsingle dose	Drug	Naprosyn 250 mg
Naprosynsingle dose	Drug	Naprosyn 500 mg
Placebosingle dose	Drug	Placebo

Primary outcome

Analysis of Total Pain Relief (TOTPAR) Over 0 to 12 Hours (TOTPAR-12) After Time 0
Time frame: Over 0 to 12 Hours
Total pain relief as computed as a time-weighted sum of individual patient pain relief scores at each timepoint from 0-12 hours. Values for TOTPAR are measured from 0 to 4 on the Pain Relief Scale 0 None Min; 1 A little; 2 Some; 3 A lot; 4 Complete Max The TOTPAR is a weighted measure of the observations; the minimum possible value is 0 and the maximum possible value is 60.

Results and safety

Results posted to the registry on 29 Mar 2012, 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 Test (Lower Dose)	51	50
Naproxen Test (Upper Dose)	51	51
Naprosyn 250 mg	50	49
Naprosyn 500 mg	51	51
Placebo	51	50

Primary outcome: Analysis of Total Pain Relief (TOTPAR) Over 0 to 12 Hours (TOTPAR-12) After Time 0

Time frame: Over 0 to 12 Hours. Least squares mean (95% Confidence Interval). Unit: units on a scale

Measure	Naproxen Test (Lower Dose) n = 50	Naproxen Test (Upper Dose) n = 51	Naprosyn 250 mg n = 50	Naprosyn 500 mg n = 51	Placebo n = 51
Value	25.868 (21.943 to 29.792)	31.948 (28.065 to 35.831)	24.373 (20.442 to 28.304)	28.549 (24.660 to 32.439)	9.531 (5.646 to 13.416)

Naproxen Test (Upper Dose) vs Placebo: Mean Difference (Net): 22.417 (95% CI 16.923 to 27.910), p <0.001, ANCOVA

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Naproxen Test (Lower Dose)	1 of 50 (2%)	28 of 51 (54.9%)	Not reported
Naproxen Test (Upper Dose)	0 of 51 (0%)	27 of 51 (52.9%)	Not reported
Naprosyn 250 mg	0 of 50 (0%)	25 of 50 (50%)	Not reported
Naprosyn 500 mg	0 of 51 (0%)	26 of 51 (51%)	Not reported
Placebo	0 of 51 (0%)	31 of 51 (60.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24127200Young CL, Strand V, Altman R, Daniels S. A phase 2 study of naproxen submicron particle capsules in patients with post-surgical dental pain. Adv Ther. 2013 Oct;30(10):885-96. doi: 10.1007/s12325-013-0057-9. Epub 2013 Oct 15.

Related trials for Dental Pain

Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
Not yet recruitingPhase 3
Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
Pulpitis
Recruiting
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Recruiting
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Symptomatic Irreversible Pulpitis (SIP), Dental Pain

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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Naproxen Test and Naprosyn in people with Dental Pain, run by Iroko Pharmaceuticals, LLC at 1 site 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 22 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 29 Mar 2012). 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?

Analysis of Total Pain Relief (TOTPAR) Over 0 to 12 Hours (TOTPAR-12) After Time 0 (time frame: Over 0 to 12 Hours). 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 NCT01229228, 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 22 May 2012.