Acute PainPhase 2NCT01872910
A Study of LY3023703 Testing Pain Relief After Wisdom Teeth Removal
A Phase 2 study testing LY3023703 and Celecoxib in people with Acute Pain, run by Eli Lilly and Company at 1 site in United States.
Trial summary
The main purpose of this study is to test if a single dose of LY3023703 relieves pain after wisdom teeth removal. The study will last about one week for each participant, not including screening. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Pain
- What is being tested?
- LY3023703 and Celecoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Oct 2013
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Have at least 2 third molars which are clinically indicated for extraction. At least 1 molar should be a mandibular third molar with partial or complete bony impaction
- Are overtly healthy as determined by medical history and limited physical examination
Who cannot join
- Have chronic pain [for example (e.g.), fibromyalgia] or are experiencing episodic pain not related to the wisdom teeth (e.g., migraine pain) that could affect pain measurements as judged by the investigator
- Have temporomandibular joint disease or other condition which could affect pain processing or sensation, affect recovery from dental surgery, or otherwise affect ability to assess pain signal, in the opinion of the investigator
- Have substantial anxiety regarding dental or medical procedures as measured by the Corah Dental Anxiety Scale
- Are currently using or have recently used drugs that may confound assessment of the inflammatory response or pain including, but not limited to, nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin and other analgesics, antihistamines, steroids, antidepressants, attention-enhancing drugs, or herbal supplements
Trial locations and contacts
1 site in 1 country.
United States1 site
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Austin, Texas, 78705
About this study
Official title: Evaluation of the Acute Analgesic Efficacy of a Single Dose of LY3023703 in Patients With Postsurgical Dental Pain: A Parallel, Double-Blind, Randomized, Placebo and Positive Control Study
The main purpose of this study is to test if a single dose of LY3023703 relieves pain after wisdom teeth removal. The study will last about one week for each participant, not including screening.
- Conditions
- Acute Pain
- Being tested
- Placebo, LY3023703, Celecoxib
- Keywords
- Wisdom tooth extraction
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Administered orally
LY3023703Drug
Also called LY3023703 phosphate
Administered orally
CelecoxibDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Part A: Single oral administration of placebo matching corresponding LY3023703 dose administered orally once as a capsule post dental surgery.
Part B: Single oral administration of placebo matching corresponding LY3023703 administered orally once as a capsule, post dental surgery and post dialysate probe placement.
Part B of this study assessed whether LY3023703 selectively inhibited the prostaglandin E(PGE) surge in the wound dialysate during the postoperative period. Receives: Drug: Placebo |
| 30 milligrams (mg) LY3023703 | Experimental | Part A: Single oral administration of 30 milligrams (mg) LY3023703 administered orally once as a 30-milligrams (mg) capsule post dental surgery.
Part B: Single oral administration of 30 milligrams (mg) LY3023703 administered orally once as a 30-mg capsule, post dental surgery and post dialysate probe placement.
Part B of this study assessed whether LY3023703 selectively inhibited the prostaglandin E(PGE) surge in the wound dialysate during the postoperative period. Receives: Drug: LY3023703 |
| 400 mg Celecoxib | Active comparator | Part A: Single oral administration of 400 mg celecoxib (Positive control) administered orally once as two 200-mg capsules post dental surgery (Positive control).
Participants received two 200-mg celecoxib capsules during Pre-Part B.The purpose of Pre-Part B was to develop proficiency in the dialysate placement, collection, and maintenance techniques before moving to Part B.
Celecoxib was not administered in Part B.
Part B of this study assessed whether LY3023703 selectively inhibited the prostaglandin E(PGE) surge in the wound dialysate during the postoperative period. Receives: Drug: Celecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Weighted Mean Change From Baseline in Pain Intensity Over the First 8 Hours Post-Dose Using VAS
Pain intensity was rated by the participant on a 100-mm VAS: 0 mm (no pain) and 100 mm (worst pain imaginable). The participant marked the line at the point that corresponded with his or her perception of pain. Weighted mean change from baseline was calculated as: [the area under the change in pain intensity versus time curve] / 8 hours (h). The baseline pain intensity was the pain assessment prior to dosing of study medication (0 h). Least Squares (LS) mean were calculated using a Bayesian analysis of covariance analysis (ANCOVA) adjusted for treatment as a fixed effect and baseline pain VAS as a continuous covariate. The measure of dispersion reported is 95% Credible Interval (CrI) not Confidence Interval (CI). A negative direction indicates a pain reduction from baseline.
Measured: 0 to 8 h post-dose
Secondary outcomes (7)
Total Pain Relief (TOPAR) Score at 4, 6, 8, 12 and 24 Hours Post-Dose
TOPAR was calculated as the area under the pain relief versus time curve of the participant reported pain relief scores from the 5-point pain relief scale of 0 (no pain relief) to 4 (complete pain relief). LS mean were calculated using ANCOVA adjusted for treatment as a fixed effect. The measure of dispersion reported is CrI not CI. A negative direction indicated a pain relief from baseline.
Pre-Part B used 3 participants in order for the study site to develop proficiency in the dialysate placement, collection, and maintenance techniques. There were no planned efficacy analysis for Pre-Part B per protocol.
Measured: 0 to 4, 0 to 6, 0 to 8, 0 to 12, and 0 to 24 h post-dose
Weighted Mean Change From Baseline in Pain Intensity Over the First 24 Hours Post-Dose as Measured by VAS
Pain intensity was rated by the participant on a 100-mm VAS: 0 mm (no pain) and 100 mm (worst pain imaginable). The participant marked the line at the point that corresponded with his or her perception of post oral surgery pain. Weighted mean change from baseline was calculated as: [area under the change in pain intensity versus time curve] / [time period that is (i.e.) 24 h for 0 to 24 h endpoint]. The baseline pain intensity was the pain assessment prior to dosing of study medication. LS mean were calculated using ANCOVA adjusted for treatment, time and interaction of treatment as a fixed effect and baseline pain VAS as a continuous covariate. The measure of dispersion reported is the 95% CrI not CI. A negative direction indicated a pain reduction from baseline.
Pre-Part B used 3 participants in order for the study site to develop proficiency in the dialysate placement, collection, and maintenance techniques. There were no planned efficacy analysis for Pre-Part B per protocol.
Measured: Part A and B: 0 to 4, 0 to 6, 0 to 12, and 0 to 24 h post-dose and Part B 0 to 8 h post-dose
Summed Pain Intensity Difference (SPID) Over the First 24 Hours Post-Dose as Measured by a 4-point Categorical Scale
The summed (time-weighted) pain intensity difference to baseline (SPID) at 4, 6, 8, 12, and 24 h post-dosing, as measured by a participant-rated 4-point categorical scale of 0 (no pain) to 3 (severe pain) and was calculated as: the area under the change in pain intensity versus time curve. Total scores range: -24 (best) to 8 (worst) for SPID 0 to 8 h. Score ranges for SPID(0-4h), SPID(0-6), SPID(0-12) and SPID(0-24) are -12 to 4, -18 to 6, -36 to 12 and -72 to 24 respectively. Participants were required to have moderate (score=2) or severe (score=3) pain at baseline in order to be eligible for randomization.LS mean were calculated using ANCOVA and was adjusted for treatment as a fixed effect and baseline pain intensity as a continuous covariate. The measure of dispersion reported is 95% CrI not CI. A negative direction indicated a pain reduction from baseline.
There were no planned efficacy analysis for Pre-Part B per protocol.
Measured: 0 to 4, 0 to 6, 0 to 8, 0 to 12, and 0 to 24 h post-dose
Time to First Use of Rescue Medication
Time to first use of rescue medication is defined as the time from study drug administration to the measured first use of rescue medication in hours. Participants were censored at 24 h post-dose if no rescue medication was administered.
Pre-Part B used 3 participants in order for the study site to develop proficiency in the dialysate placement, collection, and maintenance techniques. There were no planned efficacy analysis for Pre-Part B per protocol.
Measured: Study drug administration to first use of rescue medication (0 to 24 h post-dose)
Part A: Time to Onset of First Perceptible Pain Relief
Time to onset of the first perceptible pain relief is defined as the time from study drug administration to the measured onset of first perceptible pain relief in hours as reported by the participant. Participants who received rescue mediation prior to first perceptible pain relief were censored at the time the rescue medication was received.
Measured: Study drug administration to first perceptible pain relief (0 to 24 h post-dose)
Part A: Time to Onset of Meaningful Pain Relief
Time to onset of meaningful pain relief is defined as the time from study drug administration to the measured onset of meaningful pain relief in hours as reported by the participant. Participants who received rescue mediation prior to meaningful pain relief were censored at the time the rescue medication was received.
Measured: Study drug administration to meaningful pain relief (0 to 24 h post-dose)
Part A: Patient Global Impression of Improvement (PGI-I) Scale Score
PGI-I is a participant-rated instrument that measures the improvement of the participants symptoms on a 7-point scale: 1 (very much improved), 4 (no change), and 7 (very much worse). LS mean was calculated using Mixed Effect Model Repeated Measures (MMRM) adjusted for treatment, time, the interaction of treatment and time and baseline pain VAS and fixed effects.
Measured: 2, 4, 8, 12 and 24 h post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionOct 2013
- Study completionOct 2013
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 Acute PainStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01872910
- Sponsor's protocol ID
- 14852
- Other IDs
- I6H-MC-MCBC
- Status last verified
- Sep 2019
- First submitted
- 5 Jun 2013
- Last updated
- 23 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Acute Analgesic Efficacy of a Single Dose of LY3023703 in Patients With Postsurgical Dental Pain: A Parallel, Double-Blind, Randomized, Placebo and Positive Control Study
- ClinicalTrials.gov ID
- NCT01872910
- Acronym / sponsor ID
- 14852
- Conditions
- Acute Pain
- Keywords
- Wisdom tooth extraction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 7 Jun 2013 (estimated)
- Results
- Posted 14 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to test if a single dose of LY3023703 relieves pain after wisdom teeth removal. The study will last about one week for each participant, not including screening.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPart A: Single oral administration of placebo matching corresponding LY3023703 dose administered orally once as a capsule post dental surgery. Part B: Single oral administration of placebo matching corresponding LY3023703 administered orally once as a capsule, post dental surgery and post dialysate probe placement. Part B of this study assessed whether LY3023703 selectively inhibited the prostaglandin E(PGE) surge in the wound dialysate during the postoperative period. |
| 30 milligrams (mg) LY3023703 | Experimental | Drug: LY3023703Part A: Single oral administration of 30 milligrams (mg) LY3023703 administered orally once as a 30-milligrams (mg) capsule post dental surgery. Part B: Single oral administration of 30 milligrams (mg) LY3023703 administered orally once as a 30-mg capsule, post dental surgery and post dialysate probe placement. Part B of this study assessed whether LY3023703 selectively inhibited the prostaglandin E(PGE) surge in the wound dialysate during the postoperative period. |
| 400 mg Celecoxib | Active comparator | Drug: CelecoxibPart A: Single oral administration of 400 mg celecoxib (Positive control) administered orally once as two 200-mg capsules post dental surgery (Positive control). Participants received two 200-mg celecoxib capsules during Pre-Part B.The purpose of Pre-Part B was to develop proficiency in the dialysate placement, collection, and maintenance techniques before moving to Part B. Celecoxib was not administered in Part B. Part B of this study assessed whether LY3023703 selectively inhibited the prostaglandin E(PGE) surge in the wound dialysate during the postoperative period. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Have at least 2 third molars which are clinically indicated for extraction. At least 1 molar should be a mandibular third molar with partial or complete bony impaction
- Are overtly healthy as determined by medical history and limited physical examination
Key exclusion criteria (4 listed)
- Have chronic pain [for example (e.g.), fibromyalgia] or are experiencing episodic pain not related to the wisdom teeth (e.g., migraine pain) that could affect pain measurements as judged by the investigator
- Have temporomandibular joint disease or other condition which could affect pain processing or sensation, affect recovery from dental surgery, or otherwise affect ability to assess pain signal, in the opinion of the investigator
- Have substantial anxiety regarding dental or medical procedures as measured by the Corah Dental Anxiety Scale
- Are currently using or have recently used drugs that may confound assessment of the inflammatory response or pain including, but not limited to, nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin and other analgesics, antihistamines, steroids, antidepressants, attention-enhancing drugs, or herbal supplements
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 |
|---|---|---|
| PlaceboAdministered orally | Drug | Placebo |
| LY3023703Also: LY3023703 phosphateAdministered orally | Drug | 30 milligrams (mg) LY3023703 |
| CelecoxibAdministered orally | Drug | 400 mg Celecoxib |
Primary outcome
Part A: Weighted Mean Change From Baseline in Pain Intensity Over the First 8 Hours Post-Dose Using VAS
Time frame: 0 to 8 h post-dose
Pain intensity was rated by the participant on a 100-mm VAS: 0 mm (no pain) and 100 mm (worst pain imaginable). The participant marked the line at the point that corresponded with his or her perception of pain. Weighted mean change from baseline was calculated as: [the area under the change in pain intensity versus time curve] / 8 hours (h). The baseline pain intensity was the pain assessment prior to dosing of study medication (0 h). Least Squares (LS) mean were calculated using a Bayesian analysis of covariance analysis (ANCOVA) adjusted for treatment as a fixed effect and baseline pain VAS as a continuous covariate. The measure of dispersion reported is 95% Credible Interval (CrI) not Confidence Interval (CI). A negative direction indicates a pain reduction from baseline.
7 secondary outcomes
Total Pain Relief (TOPAR) Score at 4, 6, 8, 12 and 24 Hours Post-Dose
Time frame: 0 to 4, 0 to 6, 0 to 8, 0 to 12, and 0 to 24 h post-dose
Weighted Mean Change From Baseline in Pain Intensity Over the First 24 Hours Post-Dose as Measured by VAS
Time frame: Part A and B: 0 to 4, 0 to 6, 0 to 12, and 0 to 24 h post-dose and Part B 0 to 8 h post-dose
Summed Pain Intensity Difference (SPID) Over the First 24 Hours Post-Dose as Measured by a 4-point Categorical Scale
Time frame: 0 to 4, 0 to 6, 0 to 8, 0 to 12, and 0 to 24 h post-dose
Time to First Use of Rescue Medication
Time frame: Study drug administration to first use of rescue medication (0 to 24 h post-dose)
Part A: Time to Onset of First Perceptible Pain Relief
Time frame: Study drug administration to first perceptible pain relief (0 to 24 h post-dose)
Part A: Time to Onset of Meaningful Pain Relief
Time frame: Study drug administration to meaningful pain relief (0 to 24 h post-dose)
Part A: Patient Global Impression of Improvement (PGI-I) Scale Score
Time frame: 2, 4, 8, 12 and 24 h post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
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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.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
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 LY3023703 and Celecoxib in people with Acute Pain, run by Eli Lilly and Company 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 2 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 23 Sep 2019. 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 14 Dec 2017). 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?
Part A: Weighted Mean Change From Baseline in Pain Intensity Over the First 8 Hours Post-Dose Using VAS (time frame: 0 to 8 h post-dose). 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 23 Sep 2019.