Trial Outcomes & Findings for Study To Evaluate Efficacy And Safety Of An Additional Dose Of Celecoxib (YM177) In Patients With Post-Tooth Extraction Pain (NCT NCT01062113)
NCT ID: NCT01062113
Last Updated: 2021-02-02
Results Overview
Patient's impression was assessed by self-report and was entered in the patient diary, based on the following categories: "Excellent", " Good", "Fair" and "Poor". Efficacy rate was calculated from the following formula, "The number of participants assessed as Excellent or Good" over "total participants" multiplied by 100.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
255 participants
Primary outcome timeframe
2 hours post-additional dose
Results posted on
2021-02-02
Participant Flow
Participant milestones
| Measure |
Initial Dose Celecoxib 400 mg
Included the participants who received initial dose of celecoxib 400 mg only
|
Additional Dose Celecoxib 200 mg
Included participants who received celecoxib 200 mg as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
|
Additional Dose Placebo
Included participants who received placebo as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
|
|---|---|---|---|
|
Overall Study
STARTED
|
133
|
64
|
58
|
|
Overall Study
COMPLETED
|
93
|
42
|
27
|
|
Overall Study
NOT COMPLETED
|
40
|
22
|
31
|
Reasons for withdrawal
| Measure |
Initial Dose Celecoxib 400 mg
Included the participants who received initial dose of celecoxib 400 mg only
|
Additional Dose Celecoxib 200 mg
Included participants who received celecoxib 200 mg as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
|
Additional Dose Placebo
Included participants who received placebo as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
38
|
22
|
31
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
Baseline Characteristics
Study To Evaluate Efficacy And Safety Of An Additional Dose Of Celecoxib (YM177) In Patients With Post-Tooth Extraction Pain
Baseline characteristics by cohort
| Measure |
Initial Dose Celecoxib 400 mg
n=133 Participants
Included the participants who received initial dose of celecoxib 400 mg only
|
Additional Dose Celecoxib 200 mg
n=64 Participants
Included participants who received celecoxib 200 mg as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
|
Additional Dose Placebo
n=58 Participants
Included participants who received placebo as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
|
Total
n=255 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
< 18 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
Age, Customized
Between 18 and 64
|
133 participants
n=5 Participants
|
64 participants
n=7 Participants
|
58 participants
n=5 Participants
|
255 participants
n=4 Participants
|
|
Age, Customized
>= 65 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
139 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
116 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 2 hours post-additional dosePopulation: The full analysis set (FAS). This analysis set consisted of randomized participants who received the additional dose of the study drug and who were assessed for at least one efficacy endpoint after randomization.
Patient's impression was assessed by self-report and was entered in the patient diary, based on the following categories: "Excellent", " Good", "Fair" and "Poor". Efficacy rate was calculated from the following formula, "The number of participants assessed as Excellent or Good" over "total participants" multiplied by 100.
Outcome measures
| Measure |
Additional Dose Celecoxib 200 mg
n=64 Participants
Included participants who received celecoxib 200 mg as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
|
Additional Dose Placebo
n=58 Participants
Included participants who received placebo as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
|
|---|---|---|
|
Efficacy Rate (Percentage) of Patient's Impression
|
64.1 percentage of participants
|
25.9 percentage of participants
|
SECONDARY outcome
Timeframe: 2 hours after additional dosePopulation: The full analysis set (FAS), Baseline Observation Carried Forward (BOCF).
Pain intensity was entered in the patient diary on the following categories: "No pain", "Mild pain", "Moderate pain" and "Severe pain".
Outcome measures
| Measure |
Additional Dose Celecoxib 200 mg
n=64 Participants
Included participants who received celecoxib 200 mg as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
|
Additional Dose Placebo
n=58 Participants
Included participants who received placebo as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
|
|---|---|---|
|
Number of Participants in Each Pain Intensity (PI) With 4 Categories
None
|
11 participants
|
3 participants
|
|
Number of Participants in Each Pain Intensity (PI) With 4 Categories
Mild
|
34 participants
|
24 participants
|
|
Number of Participants in Each Pain Intensity (PI) With 4 Categories
Moderate
|
18 participants
|
28 participants
|
|
Number of Participants in Each Pain Intensity (PI) With 4 Categories
Severe
|
1 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 2 hours post-additional dosePopulation: The full analysis set (FAS), Baseline Observation Carried Forward (BOCF).
The Pain intensity was recorded on the 100 mm VAS in the patient diary, where 0 mm=no pain, 100 mm=unbearable maximal pain.
Outcome measures
| Measure |
Additional Dose Celecoxib 200 mg
n=64 Participants
Included participants who received celecoxib 200 mg as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
|
Additional Dose Placebo
n=58 Participants
Included participants who received placebo as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
|
|---|---|---|
|
Pain Intensity Measured by Visual Analog Scale (VAS)
|
35.8 mm
Standard Deviation 25.5
|
51.9 mm
Standard Deviation 21.9
|
SECONDARY outcome
Timeframe: Pre-additional dose (baseline) and 2 hours post-additional dosePopulation: The full analysis set (FAS), Baseline Observation Carried Forward (BOCF).
The differences in PI were obtained by subtracting the PI at each time point from the Baseline PI score.
Outcome measures
| Measure |
Additional Dose Celecoxib 200 mg
n=64 Participants
Included participants who received celecoxib 200 mg as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
|
Additional Dose Placebo
n=58 Participants
Included participants who received placebo as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
|
|---|---|---|
|
Differences in Pain Intensity (PI) Measured by VAS Among Participants
|
33.4 mm
Standard Deviation 24.2
|
12.3 mm
Standard Deviation 19.5
|
Adverse Events
Initial Dose Celecoxib 400 mg
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Additional Dose Celecoxib 200 mg
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Additional Dose Placebo
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Initial Dose Celecoxib 400 mg
n=133 participants at risk
Included the participants who received initial dose of celecoxib 400 mg only
|
Additional Dose Celecoxib 200 mg
n=64 participants at risk
Included participants who received celecoxib 200 mg as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
|
Additional Dose Placebo
n=58 participants at risk
Included participants who received placebo as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.75%
1/133 • From informed consent to Day 28 postdose
|
0.00%
0/64 • From informed consent to Day 28 postdose
|
0.00%
0/58 • From informed consent to Day 28 postdose
|
|
Investigations
Beta 2 microglobulin increased
|
5.3%
7/133 • From informed consent to Day 28 postdose
|
7.8%
5/64 • From informed consent to Day 28 postdose
|
15.5%
9/58 • From informed consent to Day 28 postdose
|
|
Investigations
Beta-N-acetyl-D-glucosaminidase increased
|
3.0%
4/133 • From informed consent to Day 28 postdose
|
1.6%
1/64 • From informed consent to Day 28 postdose
|
8.6%
5/58 • From informed consent to Day 28 postdose
|
|
Investigations
Blood bilirubin increased
|
3.0%
4/133 • From informed consent to Day 28 postdose
|
4.7%
3/64 • From informed consent to Day 28 postdose
|
1.7%
1/58 • From informed consent to Day 28 postdose
|
|
Investigations
Blood creatine phosphokinase increased
|
0.75%
1/133 • From informed consent to Day 28 postdose
|
1.6%
1/64 • From informed consent to Day 28 postdose
|
1.7%
1/58 • From informed consent to Day 28 postdose
|
|
Investigations
Blood phosphorus decreased
|
0.75%
1/133 • From informed consent to Day 28 postdose
|
0.00%
0/64 • From informed consent to Day 28 postdose
|
0.00%
0/58 • From informed consent to Day 28 postdose
|
|
Investigations
Blood phosphorus increased
|
0.00%
0/133 • From informed consent to Day 28 postdose
|
0.00%
0/64 • From informed consent to Day 28 postdose
|
3.4%
2/58 • From informed consent to Day 28 postdose
|
|
Investigations
Blood urea increased
|
0.00%
0/133 • From informed consent to Day 28 postdose
|
0.00%
0/64 • From informed consent to Day 28 postdose
|
1.7%
1/58 • From informed consent to Day 28 postdose
|
|
Investigations
Blood urine present
|
0.75%
1/133 • From informed consent to Day 28 postdose
|
0.00%
0/64 • From informed consent to Day 28 postdose
|
0.00%
0/58 • From informed consent to Day 28 postdose
|
|
Investigations
Protein urine present
|
0.00%
0/133 • From informed consent to Day 28 postdose
|
1.6%
1/64 • From informed consent to Day 28 postdose
|
1.7%
1/58 • From informed consent to Day 28 postdose
|
|
Investigations
Urobilin urine present
|
0.75%
1/133 • From informed consent to Day 28 postdose
|
1.6%
1/64 • From informed consent to Day 28 postdose
|
1.7%
1/58 • From informed consent to Day 28 postdose
|
|
Investigations
White blood cell count increased
|
0.75%
1/133 • From informed consent to Day 28 postdose
|
1.6%
1/64 • From informed consent to Day 28 postdose
|
3.4%
2/58 • From informed consent to Day 28 postdose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of the cervix
|
0.00%
0/133 • From informed consent to Day 28 postdose
|
1.6%
1/64 • From informed consent to Day 28 postdose
|
0.00%
0/58 • From informed consent to Day 28 postdose
|
|
Nervous system disorders
Presyncope
|
0.75%
1/133 • From informed consent to Day 28 postdose
|
0.00%
0/64 • From informed consent to Day 28 postdose
|
0.00%
0/58 • From informed consent to Day 28 postdose
|
|
Nervous system disorders
Somnolence
|
0.75%
1/133 • From informed consent to Day 28 postdose
|
1.6%
1/64 • From informed consent to Day 28 postdose
|
1.7%
1/58 • From informed consent to Day 28 postdose
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.5%
2/133 • From informed consent to Day 28 postdose
|
0.00%
0/64 • From informed consent to Day 28 postdose
|
0.00%
0/58 • From informed consent to Day 28 postdose
|
|
Skin and subcutaneous tissue disorders
Hypoaesthesia facial
|
0.75%
1/133 • From informed consent to Day 28 postdose
|
0.00%
0/64 • From informed consent to Day 28 postdose
|
0.00%
0/58 • From informed consent to Day 28 postdose
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.75%
1/133 • From informed consent to Day 28 postdose
|
0.00%
0/64 • From informed consent to Day 28 postdose
|
0.00%
0/58 • From informed consent to Day 28 postdose
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER