Dental PainPhase 2NCT00985439
Study of Diclofenac Capsules to Treat Dental Pain
A Phase 2 study testing Diclofenac Test (lower dose), Diclofenac Test (upper dose) and Celecoxib 400 mg in people with Dental Pain, run by Iroko Pharmaceuticals, LLC at 1 site in United States.
Trial summary
The purpose of this study is to determine whether Diclofenac 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 years
- Conditions the study is for
- Dental Pain
- What is being tested?
- Diclofenac Test (lower dose), Diclofenac Test (upper dose) and Celecoxib 400 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 202 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Dec 2009
- 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
- No healthy volunteers
- 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.
About this study
Official title: A Phase 2, Randomized, Double-Blind, Single-Dose, Parallel-Group, Active- and Placebo-Controlled Study of Diclofenac [Test] Capsules for the Treatment of Pain After Surgical Removal of Impacted Third Molars
The purpose of this study is to determine whether Diclofenac Test Formulation Capsules are safe and effective for the treatment of dental pain.
- Conditions
- Dental Pain
- Being tested
- Diclofenac Test (lower dose), Diclofenac Test (upper dose), Celecoxib 400 mg, Placebo
- Medical subject headings
- Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diclofenac Test (lower dose)Drug
18-mg Single dose
Diclofenac Test (upper dose)Drug
35-mg Single dose
Celecoxib 400 mgDrug
Capsules 2 x 200 mg Single-dose
PlaceboDrug
Capsules 2 Single-dose
| Study group | Role | What they receive |
|---|---|---|
| Diclofenac Test (lower dose) | Experimental | One 18-mg Diclofenac Test Capsule and 1 placebo capsule Receives: Drug: Diclofenac Test (lower dose) |
| Diclofenac Test (upper dose) | Experimental | One 35-mg Diclofenac Test Capsule and 1 placebo capsule Receives: Drug: Diclofenac Test (upper dose) |
| Celecoxib 400 mg | Active comparator | Not described Receives: Drug: Celecoxib 400 mg |
| 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.
Total Patient Pain Relief Over 0 to 12 Hours.
Total patient pain relief was assessed as a time-weighted sum of the patient pain assessments at each individual time point 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: 12 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2009
- Study completionDec 2009
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.
- 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
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iroko Pharmaceuticals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00985439
- Sponsor's protocol ID
- DIC2-08-03
- Status last verified
- Mar 2012
- First submitted
- 25 Sep 2009
- Last updated
- 22 May 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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 Diclofenac [Test] Capsules for the Treatment of Pain After Surgical Removal of Impacted Third Molars
- ClinicalTrials.gov ID
- NCT00985439
- Acronym / sponsor ID
- DIC2-08-03
- Conditions
- Dental Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Iroko Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 28 Sep 2009 (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 this study is to determine whether Diclofenac 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
- 4
| Arm | Type | Receives |
|---|---|---|
| Diclofenac Test (lower dose) | Experimental | Drug: Diclofenac Test (lower dose)One 18-mg Diclofenac Test Capsule and 1 placebo capsule |
| Diclofenac Test (upper dose) | Experimental | Drug: Diclofenac Test (upper dose)One 35-mg Diclofenac Test Capsule and 1 placebo capsule |
| Celecoxib 400 mg | Active comparator | Drug: Celecoxib 400 mg |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not 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 |
|---|---|---|
| Diclofenac Test (lower dose)18-mg Single dose | Drug | Diclofenac Test (lower dose) |
| Diclofenac Test (upper dose)35-mg Single dose | Drug | Diclofenac Test (upper dose) |
| Celecoxib 400 mgCapsules 2 x 200 mg Single-dose | Drug | Celecoxib 400 mg |
| PlaceboCapsules 2 Single-dose | Drug | Placebo |
Primary outcome
Total Patient Pain Relief Over 0 to 12 Hours.
Time frame: 12 hours.
Total patient pain relief was assessed as a time-weighted sum of the patient pain assessments at each individual time point 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
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.
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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.
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 Diclofenac Test (lower dose), Diclofenac Test (upper dose) and Celecoxib 400 mg 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?
Total Patient Pain Relief Over 0 to 12 Hours. (time frame: 12 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.