Dental PainPhase 2NCT00663767
A Study of ARRY-371797 in Subjects Undergoing Third Molar Extraction
A Phase 2 study testing ARRY-371797, p38 inhibitor; oral and Celecoxib, COX-2 inhibitor; oral in people with Dental Pain, run by Pfizer at 2 sites in United States.
Trial summary
This is a Phase 2 study designed to test the ability of investigational study drug ARRY-371797 to reduce pain in a postoperative pain model (third molar extraction), and to further evaluate the drug's safety. Approximately 250 subjects from the US will be enrolled in this study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dental Pain
- What is being tested?
- ARRY-371797, p38 inhibitor; oral and Celecoxib, COX-2 inhibitor; oral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Apr 2008to 20 Jun 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for outpatient oral surgical procedure to remove 3 or more third molars, at least 1 of which is mandibular and fully or partially impacted by bone.
- Females of childbearing potential must be willing to use an acceptable method of contraception within 14 days prior to first dose of study drug until the completion of the follow-up procedures.
- Body weight >50 kg (110 lbs).
- Good health determined by medical history, physical examination, vital signs and clinical laboratory results of non-clinical significance.
- Additional criteria exist.
Who cannot join
- Evidence or history of clinically significant dermatologic, hematological, renal, endocrine (e.g. poorly controlled diabetes), pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic, ophthalmologic, or allergic disease (including clinically significant drug allergies that could impact the conduct of this study, but excluding untreated, asymptomatic, seasonal allergies at time of study drug dosing).
- Positive urine drug screen within 28 days prior to first dose of study drug.
- Use of prohibited prescription drugs, or grapefruit juice within 7 days of first dose of study drug; prohibited medications are defined as nonsteroidal and steroidal antiinflammatory drugs, analgesics including opioids (except low dose aspirin for myocardial infarction prophylaxis), P450 CYP3A substrates or inhibitors (strong or moderate).
- Additional criteria exist.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
PPD Phase I Clinic
Austin, Texas, 78744
Lifetree Clinical Research
Salt Lake City, Utah, 84106
About this study
Official title: A Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group Analgesic Efficacy Trial of Oral ARRY-371797 in Subjects Undergoing Third Molar Extraction
This is a Phase 2 study designed to test the ability of investigational study drug ARRY-371797 to reduce pain in a postoperative pain model (third molar extraction), and to further evaluate the drug's safety. Approximately 250 subjects from the US will be enrolled in this study.
- Conditions
- Dental Pain
- Being tested
- Placebo; oral, ARRY-371797, p38 inhibitor; oral, Celecoxib, COX-2 inhibitor; oral
- Medical subject headings
- Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo; oralDrug
dose 1, dose 2
Placebo; oralDrug
dose 1
ARRY-371797, p38 inhibitor; oralDrug
dose 1: multiple dose levels
ARRY-371797, p38 inhibitor; oralDrug
dose 1: multiple dose levels; dose 2
Celecoxib, COX-2 inhibitor; oralDrug
dose 1
Placebo; oralDrug
dose 2
ARRY-371797, p38 inhibitor; oralDrug
dose 2
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo; oral |
| Placebo, ARRY-371797 | Experimental | Not described Receives: Drug: Placebo; oral; Drug: ARRY-371797, p38 inhibitor; oral |
| ARRY-371797, Placebo | Experimental | Not described Receives: Drug: ARRY-371797, p38 inhibitor; oral; Drug: Placebo; oral |
| ARRY-371797 | Experimental | Not described Receives: Drug: ARRY-371797, p38 inhibitor; oral |
| Celecoxib, Placebo | Active comparator | Not described Receives: Drug: Celecoxib, COX-2 inhibitor; oral; Drug: Placebo; oral |
| Celecoxib, ARRY-371797 | Experimental | Not described Receives: Drug: Celecoxib, COX-2 inhibitor; oral; Drug: ARRY-371797, p38 inhibitor; oral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the efficacy of the study drug dosed postoperatively in terms of total pain relief (TOTPAR).
Measured: 6 hours post-dose
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, electrocardiograms and vital signs.
Measured: Duration of study
Secondary outcomes (1)
Assess the efficacy of the study drug (versus placebo and celecoxib) in terms of pain relief measurements [including TOTPAR, total pain intensity (TPI) and time to rescue medication].
Measured: Duration of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
- Study start7 Apr 2008
- Primary completion20 Jun 2008
- Study completion20 Jun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental PainStudies of the same condition, open and under way.
- More trials run by PfizerThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00663767
- Sponsor's protocol ID
- ARRAY-797-222
- Other IDs
- C4411009
- Status last verified
- Feb 2021
- First submitted
- 18 Apr 2008
- Last updated
- 9 Feb 2021
- Results posted
- No
- Individual data sharing
- Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group Analgesic Efficacy Trial of Oral ARRY-371797 in Subjects Undergoing Third Molar Extraction
- ClinicalTrials.gov ID
- NCT00663767
- Acronym / sponsor ID
- ARRAY-797-222
- Conditions
- Dental Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 7 Apr 2008 (actual)
- Primary completion
- 20 Jun 2008 (actual)
- Study completion
- 20 Jun 2008 (actual)
- First posted
- 22 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2 study designed to test the ability of investigational study drug ARRY-371797 to reduce pain in a postoperative pain model (third molar extraction), and to further evaluate the drug's safety. Approximately 250 subjects from the US will be enrolled in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo; oral |
| Placebo, ARRY-371797 | Experimental | Drug: Placebo; oral, Drug: ARRY-371797, p38 inhibitor; oral |
| ARRY-371797, Placebo | Experimental | Drug: ARRY-371797, p38 inhibitor; oral, Drug: Placebo; oral |
| ARRY-371797 | Experimental | Drug: ARRY-371797, p38 inhibitor; oral |
| Celecoxib, Placebo | Active comparator | Drug: Celecoxib, COX-2 inhibitor; oral, Drug: Placebo; oral |
| Celecoxib, ARRY-371797 | Experimental | Drug: Celecoxib, COX-2 inhibitor; oral, Drug: ARRY-371797, p38 inhibitor; oral |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Scheduled for outpatient oral surgical procedure to remove 3 or more third molars, at least 1 of which is mandibular and fully or partially impacted by bone.
- Females of childbearing potential must be willing to use an acceptable method of contraception within 14 days prior to first dose of study drug until the completion of the follow-up procedures.
- Body weight >50 kg (110 lbs).
- Good health determined by medical history, physical examination, vital signs and clinical laboratory results of non-clinical significance.
- Additional criteria exist.
Key exclusion criteria (4 listed)
- Evidence or history of clinically significant dermatologic, hematological, renal, endocrine (e.g. poorly controlled diabetes), pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic, ophthalmologic, or allergic disease (including clinically significant drug allergies that could impact the conduct of this study, but excluding untreated, asymptomatic, seasonal allergies at time of study drug dosing).
- Positive urine drug screen within 28 days prior to first dose of study drug.
- Use of prohibited prescription drugs, or grapefruit juice within 7 days of first dose of study drug; prohibited medications are defined as nonsteroidal and steroidal antiinflammatory drugs, analgesics including opioids (except low dose aspirin for myocardial infarction prophylaxis), P450 CYP3A substrates or inhibitors (strong or moderate).
- Additional criteria exist.
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 |
|---|---|---|
| Placebo; oraldose 1, dose 2 | Drug | Placebo |
| Placebo; oraldose 1 | Drug | Placebo, ARRY-371797 |
| ARRY-371797, p38 inhibitor; oraldose 1: multiple dose levels | Drug | ARRY-371797, Placebo |
| ARRY-371797, p38 inhibitor; oraldose 1: multiple dose levels; dose 2 | Drug | ARRY-371797 |
| Celecoxib, COX-2 inhibitor; oraldose 1 | Drug | Celecoxib, ARRY-371797, Celecoxib, Placebo |
| Placebo; oraldose 2 | Drug | ARRY-371797, Placebo, Celecoxib, Placebo |
| ARRY-371797, p38 inhibitor; oraldose 2 | Drug | Celecoxib, ARRY-371797, Placebo, ARRY-371797 |
Primary outcome
Assess the efficacy of the study drug dosed postoperatively in terms of total pain relief (TOTPAR).
Time frame: 6 hours post-dose
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, electrocardiograms and vital signs.
Time frame: Duration of study
1 secondary outcome
Assess the efficacy of the study drug (versus placebo and celecoxib) in terms of pain relief measurements [including TOTPAR, total pain intensity (TPI) and time to rescue medication].
Time frame: Duration of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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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.
Pfizer CT.gov Call Center study director
Pfizer
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ARRY-371797, p38 inhibitor; oral and Celecoxib, COX-2 inhibitor; oral in people with Dental Pain, run by Pfizer at 2 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 5 inclusion and 4 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 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assess the efficacy of the study drug dosed postoperatively in terms of total pain relief (TOTPAR). (time frame: 6 hours post-dose). The study lists 2 primary outcomes in all. 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 9 Feb 2021.