An Open-Label Study Of Celecoxib In Patients With Posttraumatic Pain
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00976716
Collaborator
(none)
80
11
1
2
7.3
3.6
Study Details
Study Description
Brief Summary
To investigate efficacy, safety and tolerability of Celecoxib in patients with posttraumatic pain for the duration of 8 days.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
80 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label, Multicenter Study To Evaluate The Efficacy, Safety And Tolerability Of Celecoxib (YM177) In Patients With Posttraumatic Pain
Study Start Date
:
Sep 1, 2009
Actual Primary Completion Date
:
Nov 1, 2009
Actual Study Completion Date
:
Nov 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Celecoxib
|
Drug: Celecoxib
Day 1
The first dose: Celecoxib 400mg
The second dose: Celecoxib 200mg during a period between 6 hours post-first dose and before bed
Days 2 to 8 (Study drug should be taken until the dose scheduled after breakfast on the day of Day 8)
- Celecoxib 200mg twice daily
|
Outcome Measures
Primary Outcome Measures
- Patient Impressions at Final Visit (the Number of Participants Who Have Rated "Excellent" and "Good") [8 days]
The patient impression of the study medication was entered in the patient diary based on the following categories: "excellent," "good," "fair" and "poor." Efficacy was based on the patient impression of the study medication ("excellent" and "good") from the first study medication until Final Visit.
Secondary Outcome Measures
- Patient Impressions Within 8 Days Post-first Dose (the Number of Subjects Who Have Rated "Excellent" and "Good") [6 hours post first dose and before sleep on Day 1, before sleep on Day 2, Day 4 (Visit 2) and Day 8 (Visit 3)]
The patient impression of the study medication was entered in the patient diary based on the following categories: "excellent," "good," "fair" and "poor." Efficacy was based on the patient impression of the study medication ("excellent" and "good") from the first study medication until each time point.
- Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose [Baseline, 2, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8)]
The PI of pain at rest (spontaneous pain) was recorded on the 100 mm VAS in the patient diary, where 0 mm=no pain, 100 mm=worst possible pain.
- PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose [Baseline, 2, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8)]
The PI of pain on active movement was recorded on the 100 mm VAS in the patient diary, where 0 mm=no pain, 100 mm=worst possible pain.
- Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose [Two, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8)]
The PID score was obtained by subtracting the PI (by VAS: 0 mm=no pain, 100 mm=worst possible pain) at each time point from the Baseline PI score. Increase in PID scores indicated a lessening of subjects' pain compared to baseline scores; higher scores indicated a greater reduction in pain.
- PID in Pain on Active Movement Within 8 Days Post-first Dose [2, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8)]
The PID score was obtained by subtracting the PI at each time point from the Baseline PI score. Increase in scores indicated a lessening of subjects' pain compared to baseline scores; higher scores indicated a greater reduction in pain.
- Sum of Pain Intensity Differences (SPID) for Pain at Rest (Spontaneous Pain) and on Active Movement Until 6 Hours Post-first Dose [6 hours]
The SPID was derived according to the following rule: each PID was weighted by the width of time interval between previous and current time points in hours and summed up to 6 hours post-first dose
- Peak Pain Intensity Difference (PPID) for Pain at Rest (Spontaneous Pain) and on Active Movement Until 6 Hours Post-first Dose [Two, 4 and 6 hours post first dose]
The PPID was obtained by subtracting the maximum value of pain intensity (PI) at a time point among 2 to 6 hours post first dose from baseline value of PI for each patient.
- Severity of Inflammatory Symptoms (Swelling) Within 8 Days Post-first Dose [Baseline, Days 4 (Visit 2) and 8 (Visit 3)]
The investigator assessed the swelling, using the categories "None," "Mild," "Moderate," and "Severe" at Baseline, Visit 2 (Day 4), Visit 3 (Day 8) and Final Visit.
- Severity of Inflammatory Symptoms (Redness) Within 8 Days Post-first Dose [Baseline, Days 4 (Visit 2) and 8 (Visit 3)]
The investigator assessed the redness, using the categories "None," "Mild," "Moderate," and "Severe" at Baseline, Visit 2 (Day 4), Visit 3 (Day 8) and Final Visit.
- Severity of Inflammatory Symptoms (Localized Warmth) Within 8 Days Post First Dose [Baseline, Days 4 (Visit 2) and 8 (Visit 3)]
The investigator assessed the localized warmth, using the categories "None," "Mild," "Moderate," and "Severe" at Baseline, Visit 2 (Day 4), Visit 3 (Day 8) and Final Visit.
- Withdrawal Due to Lack of Efficacy [8 days]
The number of subjects who withdrew due to insufficient clinical response was evaluated.
- Summary of Adverse Events [8 days]
The number of subjects who experienced adverse events (AEs; all-causality and treatment-related) based on safety assessment was summarized. The severity and seriousness of treatment-emergent AEs as well as discontinuations, dose reductions and temporary discontinuations (DR/TD) due to treatment-emergent AEs were also summarized.
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Patients with posttraumatic pain which is able to be controlled with an oral NSAID
-
Patients with "pain" that meets both of the following criteria within 48 hours after injury:
"Pain" Pain intensity (Categorical): "Moderate pain" or "Severe pain" Pain intensity (VAS): 45.0 mm or more
- Patients with "inflammation" that meets the following criteria within 48 hours after injury.
"Inflammation" Categorical: "Mild", "Moderate" or "Severe"
Exclusion Criteria:
-
Patients who have received analgesics and anaesthetics for injury
-
Patients with a history/complication of aspirin-induced asthma
-
Patients taking excluded medications
-
Patients with a history/complication of ischaemic heart disease, serious cardiac arrhythmias, cardiac failure congestive and cerebrovascular disorder or with a history/plan of revascularization
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Funabashi | Chiba | Japan | |
| 2 | Pfizer Investigational Site | Ichikawa | Chiba | Japan | |
| 3 | Pfizer Investigational Site | Matsudo | Chiba | Japan | |
| 4 | Pfizer Investigational Site | Sagamihara | Kanagawa | Japan | |
| 5 | Pfizer Investigational Site | Ageo | Saitama | Japan | |
| 6 | Pfizer Investigational Site | Saitama-shi | Saitama | Japan | |
| 7 | Pfizer Investigational Site | Edogawaku | Tokyo | Japan | |
| 8 | Pfizer Investigational Site | Kotoku | Tokyo | Japan | |
| 9 | Pfizer Investigational Site | Nerimaku | Tokyo | Japan | |
| 10 | Pfizer Investigational Site | Toshimaku | Tokyo | Japan | |
| 11 | Pfizer Investigational Site | Kofu | Yamanashi | Japan |
Sponsors and Collaborators
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT00976716
Other Study ID Numbers:
- A3191357
First Posted:
Sep 14, 2009
Last Update Posted:
Feb 2, 2021
Last Verified:
Jan 1, 2021
Keywords provided by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Subjects were screened at 12 centers in Japan. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Celecoxib |
|---|---|
| Arm/Group Description | Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID (twice daily) for up to 7 days from Day 2. |
| Period Title: Overall Study | |
| STARTED | 80 |
| COMPLETED | 79 |
| NOT COMPLETED | 1 |
Baseline Characteristics
| Arm/Group Title | Celecoxib |
|---|---|
| Arm/Group Description | Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2. |
| Overall Participants | 80 |
| Age (Years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [Years] |
37.1
(14.4)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
39
48.8%
|
| Male |
41
51.3%
|
Outcome Measures
| Title | Patient Impressions at Final Visit (the Number of Participants Who Have Rated "Excellent" and "Good") |
|---|---|
| Description | The patient impression of the study medication was entered in the patient diary based on the following categories: "excellent," "good," "fair" and "poor." Efficacy was based on the patient impression of the study medication ("excellent" and "good") from the first study medication until Final Visit. |
| Time Frame | 8 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| The full analysis set (FAS) consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the last observation carried forward (LOCF) was used. |
| Arm/Group Title | Celecoxib |
|---|---|
| Arm/Group Description | Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2. |
| Measure Participants | 80 |
| Number [Participants] |
70
87.5%
|
| Title | Patient Impressions Within 8 Days Post-first Dose (the Number of Subjects Who Have Rated "Excellent" and "Good") |
|---|---|
| Description | The patient impression of the study medication was entered in the patient diary based on the following categories: "excellent," "good," "fair" and "poor." Efficacy was based on the patient impression of the study medication ("excellent" and "good") from the first study medication until each time point. |
| Time Frame | 6 hours post first dose and before sleep on Day 1, before sleep on Day 2, Day 4 (Visit 2) and Day 8 (Visit 3) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. |
| Arm/Group Title | Celecoxib |
|---|---|
| Arm/Group Description | Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2. |
| Measure Participants | 80 |
| Day 1, 6 hours post first dose (n=80) |
44
55%
|
| Day 1, before sleep (n=80) |
48
60%
|
| Day 2, before sleep (n=80) |
55
68.8%
|
| Visit 2 (Day 4), (n=80) |
60
75%
|
| Visit 3 (Day 8), (n=68) |
60
75%
|
| Title | Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose |
|---|---|
| Description | The PI of pain at rest (spontaneous pain) was recorded on the 100 mm VAS in the patient diary, where 0 mm=no pain, 100 mm=worst possible pain. |
| Time Frame | Baseline, 2, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used. |
| Arm/Group Title | Celecoxib |
|---|---|
| Arm/Group Description | Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2. |
| Measure Participants | 80 |
| Baseline (n=80) |
59.9
(11.4)
|
| Day 1, 2 hours post first dose (n=80) |
47.3
(19.5)
|
| Day 1, 4 hours post first dose (n=80) |
42.5
(20.5)
|
| Day 1, 6 hours post first dose (n=80) |
40.3
(20.9)
|
| Day 1, before sleep (n=80) |
38.1
(20.0)
|
| Day 2, on awakening (n=80) |
34.8
(21.5)
|
| Day 2, before sleep (n=80) |
29.0
(22.0)
|
| Day 3, on awakening (n=80) |
24.8
(20.0)
|
| Day 3, before sleep (n=78) |
21.8
(19.1)
|
| Day 4, on awakening (n=78) |
18.4
(19.6)
|
| Day 4, before sleep (n=73) |
17.8
(18.9)
|
| Day 5, on awakening (n=73) |
15.3
(18.0)
|
| Day 5, before sleep (n=68) |
15.0
(18.7)
|
| Day 6, on awakening (n=68) |
12.4
(17.2)
|
| Day 6, before sleep (n=68) |
11.6
(17.3)
|
| Day 7, on awakening (n=68) |
11.3
(18.1)
|
| Day 7, before sleep (n=55) |
9.7
(16.2)
|
| Day 8, on awakening (n=55) |
8.6
(13.3)
|
| Visit 3 (Day 8) (n=73) |
7.2
(13.0)
|
| Final Visit (LOCF, n=80) |
7.3
(13.4)
|
| Title | PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose |
|---|---|
| Description | The PI of pain on active movement was recorded on the 100 mm VAS in the patient diary, where 0 mm=no pain, 100 mm=worst possible pain. |
| Time Frame | Baseline, 2, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used. |
| Arm/Group Title | Celecoxib |
|---|---|
| Arm/Group Description | Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2 |
| Measure Participants | 79 |
| Baseline (n=79) |
75.5
(12.7)
|
| Day 1, 2 hours post first dose (n=77) |
61.4
(20.2)
|
| Day 1, 4 hours post first dose (n=77) |
55.3
(21.0)
|
| Day 1, 6 hours post first dose (n=77) |
51.5
(20.6)
|
| Day 1, before sleep (n=77) |
49.3
(21.0)
|
| Day 2, on awakening (n=77) |
45.5
(21.4)
|
| Day 2, before sleep (n=77) |
39.7
(22.6)
|
| Day 3, on awakening (n=77) |
35.5
(22.3)
|
| Day 3, before sleep (n=75) |
32.4
(21.8)
|
| Day 4, on awakening (n=75) |
27.2
(22.9)
|
| Day 4, before sleep (n=70) |
26.4
(21.0)
|
| Day 5, on awakening (n=70) |
23.5
(21.4)
|
| Day 5, before sleep (n=66) |
23.2
(22.0)
|
| Day 6, on awakening (n=66) |
19.2
(20.4)
|
| Day 6, before sleep (n=66) |
18.2
(20.1)
|
| Day 7, on awakening (n=66) |
17.1
(21.7)
|
| Day 7, before sleep (n=55) |
15.5
(20.7)
|
| Day 8, on awakening (n=55) |
14.3
(20.0)
|
| Visit 3 (Day8) (n=71) |
12.1
(18.7)
|
| Final Visit (LOCF, n=78) |
11.8
(18.7)
|
| Title | Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose |
|---|---|
| Description | The PID score was obtained by subtracting the PI (by VAS: 0 mm=no pain, 100 mm=worst possible pain) at each time point from the Baseline PI score. Increase in PID scores indicated a lessening of subjects' pain compared to baseline scores; higher scores indicated a greater reduction in pain. |
| Time Frame | Two, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used. |
| Arm/Group Title | Celecoxib |
|---|---|
| Arm/Group Description | Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2. |
| Measure Participants | 80 |
| Day 1, 2 hours post first dose (n=80) |
12.6
(14.8)
|
| Day 1, 4 hours post first dose (n=80) |
17.4
(16.0)
|
| Day 1, 6 hours post first dose (n=80) |
19.6
(16.3)
|
| Day 1, before sleep (n=80) |
21.8
(16.8)
|
| Day 2, on awakening (n=80) |
25.1
(19.1)
|
| Day 2, before sleep (n=80) |
30.9
(20.8)
|
| Day 3, on awakening (n=80) |
35.1
(18.7)
|
| Day 3, before sleep (n=78) |
37.9
(18.8)
|
| Day 4, on awakening (n=78) |
41.3
(19.7)
|
| Day 4, before sleep (n=73) |
41.8
(19.2)
|
| Day 5, on awakening (n=73) |
44.3
(18.4)
|
| Day 5, before sleep (n=68) |
45.4
(19.5)
|
| Day 6, on awakening (n=68) |
48.0
(17.7)
|
| Day 6, before sleep (n=68) |
48.8
(18.1)
|
| Day 7, on awakening (n=68) |
49.2
(19.0)
|
| Day 7, before sleep (n=55) |
50.2
(18.7)
|
| Day 8, on awakening (n=55) |
51.3
(17.3)
|
| Visit 3 (Day 8) (n=73) |
52.4
(15.5)
|
| Final Visit (LOCF, n=80) |
52.6
(15.2)
|
| Title | PID in Pain on Active Movement Within 8 Days Post-first Dose |
|---|---|
| Description | The PID score was obtained by subtracting the PI at each time point from the Baseline PI score. Increase in scores indicated a lessening of subjects' pain compared to baseline scores; higher scores indicated a greater reduction in pain. |
| Time Frame | 2, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used. |
| Arm/Group Title | Celecoxib |
|---|---|
| Arm/Group Description | Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2 |
| Measure Participants | 79 |
| Day 1, 2 hours post first dose (n=77) |
14.3
(16.6)
|
| Day 1, 4 hours post first dose (n=77) |
20.4
(17.1)
|
| Day 1, 6 hours post first dose (n=77) |
24.3
(17.5)
|
| Day 1, before sleep (n=77) |
26.5
(17.5)
|
| Day 2, on awakening (n=77) |
30.3
(19.2)
|
| Day 2, before sleep (n=77) |
36.1
(22.0)
|
| Day 3, on awakening (n=77) |
40.2
(21.2)
|
| Day 3, before sleep (n=75) |
43.2
(21.5)
|
| Day 4, on awakening (n=75) |
48.5
(22.3)
|
| Day 4, before sleep (n=70) |
49.5
(20.6)
|
| Day 5, on awakening (n=70) |
52.5
(20.8)
|
| Day 5, before sleep (n=66) |
53.5
(21.6)
|
| Day 6, on awakening (n=66) |
57.5
(19.7)
|
| Day 6, before sleep (n=66) |
58.4
(19.9)
|
| Day 7, on awakening (n=66) |
59.6
(21.4)
|
| Day 7, before sleep (n=55) |
62.1
(20.6)
|
| Day 8, on awakening (n=55) |
63.3
(20.6)
|
| Visit 3 (Day 8) (n=71) |
63.6
(18.6)
|
| Final Visit (LOCF, n=78) |
63.7
(18.1)
|
| Title | Sum of Pain Intensity Differences (SPID) for Pain at Rest (Spontaneous Pain) and on Active Movement Until 6 Hours Post-first Dose |
|---|---|
| Description | The SPID was derived according to the following rule: each PID was weighted by the width of time interval between previous and current time points in hours and summed up to 6 hours post-first dose |
| Time Frame | 6 hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement. If a patient withdrew the study before 6 hours on Day 1 and the measurement of the PI at 6 hours on Day 1 was missing, the LOCF method was used for the PI at 6 hours on Day 1 to derive the SPID. |
| Arm/Group Title | Celecoxib |
|---|---|
| Arm/Group Description | Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2. |
| Measure Participants | 80 |
| Pain at rest (n=80) |
99.3
|
| Pain on active movement (n=77) |
118.2
|
| Title | Peak Pain Intensity Difference (PPID) for Pain at Rest (Spontaneous Pain) and on Active Movement Until 6 Hours Post-first Dose |
|---|---|
| Description | The PPID was obtained by subtracting the maximum value of pain intensity (PI) at a time point among 2 to 6 hours post first dose from baseline value of PI for each patient. |
| Time Frame | Two, 4 and 6 hours post first dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. |
| Arm/Group Title | Celecoxib |
|---|---|
| Arm/Group Description | Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2. |
| Measure Participants | 80 |
| Pain at rest (n=80) |
22.2
|
| Pain on active movement (n=77) |
26.7
|
| Title | Severity of Inflammatory Symptoms (Swelling) Within 8 Days Post-first Dose |
|---|---|
| Description | The investigator assessed the swelling, using the categories "None," "Mild," "Moderate," and "Severe" at Baseline, Visit 2 (Day 4), Visit 3 (Day 8) and Final Visit. |
| Time Frame | Baseline, Days 4 (Visit 2) and 8 (Visit 3) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used. |
| Arm/Group Title | Celecoxib |
|---|---|
| Arm/Group Description | Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2. |
| Measure Participants | 80 |
| None at Baseline (n=80) |
0
0%
|
| None at Visit 2 (Day 4) (n=80) |
5
6.3%
|
| None at Visit 3 (Day 8) (n=68) |
38
47.5%
|
| None at Final Visit (n=80) |
41
51.3%
|
| Mild at Baseline (n=80) |
24
30%
|
| Mild at Visit 2 (Day 4) (n=80) |
69
86.3%
|
| Mild at Visit 3 (Day 8) (n=68) |
26
32.5%
|
| Mild at Final Visit (n=80) |
35
43.8%
|
| Moderate at Baseline (n=80) |
48
60%
|
| Moderate at Visit 2 (Day 4) (n=80) |
5
6.3%
|
| Moderate at Visit 3 (Day 8) (n=68) |
4
5%
|
| Moderate at Final Visit (n=80) |
4
5%
|
| Severe at Baseline (n=80) |
8
10%
|
| Severe at Visit 2 (Day 4) (n=80) |
1
1.3%
|
| Severe at Visit 3 (Day 8) (n=68) |
0
0%
|
| Severe at Final Visit (n=80) |
0
0%
|
| Title | Severity of Inflammatory Symptoms (Redness) Within 8 Days Post-first Dose |
|---|---|
| Description | The investigator assessed the redness, using the categories "None," "Mild," "Moderate," and "Severe" at Baseline, Visit 2 (Day 4), Visit 3 (Day 8) and Final Visit. |
| Time Frame | Baseline, Days 4 (Visit 2) and 8 (Visit 3) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used. |
| Arm/Group Title | Celecoxib |
|---|---|
| Arm/Group Description | Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2 |
| Measure Participants | 80 |
| None at Baseline (n=80) |
16
20%
|
| None at Visit 2 (Day 4) (n=80) |
51
63.8%
|
| None at Visit 3 (Day 8) (n=68) |
64
80%
|
| None at Final Visit (n=80) |
73
91.3%
|
| Mild at Baseline (n=80) |
40
50%
|
| Mild at Visit 2 (Day 4) (n=80) |
28
35%
|
| Mild at Visit 3 (Day 8) (n=68) |
4
5%
|
| Mild at Final Visit (n=80) |
7
8.8%
|
| Moderate at Baseline (n=80) |
19
23.8%
|
| Moderate at Visit 2 (Day 4) (n=80) |
1
1.3%
|
| Moderate at Visit 3 (Day 8) (n=68) |
0
0%
|
| Moderate at Final Visit (n=80) |
0
0%
|
| Severe at Baseline (n=80) |
5
6.3%
|
| Severe at Visit 2 (Day 4) (n=80) |
0
0%
|
| Severe at Visit 3 (Day 8) (n=68) |
0
0%
|
| Severe at Final Visit (n=80) |
0
0%
|
| Title | Severity of Inflammatory Symptoms (Localized Warmth) Within 8 Days Post First Dose |
|---|---|
| Description | The investigator assessed the localized warmth, using the categories "None," "Mild," "Moderate," and "Severe" at Baseline, Visit 2 (Day 4), Visit 3 (Day 8) and Final Visit. |
| Time Frame | Baseline, Days 4 (Visit 2) and 8 (Visit 3) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used. |
| Arm/Group Title | Celecoxib |
|---|---|
| Arm/Group Description | Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2 |
| Measure Participants | 80 |
| None at Baseine (n=80) |
8
10%
|
| None at Visit 2 (Day 4) (n=80) |
63
78.8%
|
| None at Visit 3 (Day 8) (n=68) |
66
82.5%
|
| None at Final Visit (n=80) |
76
95%
|
| Mild at Baseine (n=80) |
43
53.8%
|
| Mild at Visit 2 (Day 4) (n=80) |
17
21.3%
|
| Mild at Visit 3 (Day 8) (n=68) |
2
2.5%
|
| Mild at Final Visit (n=80) |
4
5%
|
| Moderate at Baseine (n=80) |
23
28.8%
|
| Moderate at Visit 2 (Day 4) (n=80) |
0
0%
|
| Moderate at Visit 3 (Day 8) (n=68) |
0
0%
|
| Moderate at Final Visit (n=80) |
0
0%
|
| Severe at Baseine (n=80) |
6
7.5%
|
| Severe at Visit 2 (Day 4) (n=80) |
0
0%
|
| Severe at Visit 3 (Day 8) (n=68) |
0
0%
|
| Severe at Final Visit (n=80) |
0
0%
|
| Title | Withdrawal Due to Lack of Efficacy |
|---|---|
| Description | The number of subjects who withdrew due to insufficient clinical response was evaluated. |
| Time Frame | 8 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. |
| Arm/Group Title | Celecoxib |
|---|---|
| Arm/Group Description | Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2. |
| Measure Participants | 80 |
| Number [Participants] |
0
0%
|
| Title | Summary of Adverse Events |
|---|---|
| Description | The number of subjects who experienced adverse events (AEs; all-causality and treatment-related) based on safety assessment was summarized. The severity and seriousness of treatment-emergent AEs as well as discontinuations, dose reductions and temporary discontinuations (DR/TD) due to treatment-emergent AEs were also summarized. |
| Time Frame | 8 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety analysis set consisted of all patients who had taken at least one study medication. |
| Arm/Group Title | Celecoxib |
|---|---|
| Arm/Group Description | Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2. |
| Measure Participants | 80 |
| AEs: all-causality |
10
12.5%
|
| AEs: treatment-related |
8
10%
|
| Severe AEs: all-causality |
0
0%
|
| Severe AEs: treatment-realted |
0
0%
|
| Serious AEs: all-causality |
0
0%
|
| Serious AEs: treatment-related |
0
0%
|
| Discontinuation due to all-causality AEs |
1
1.3%
|
| Discontinuation due to treatment-related AEs |
1
1.3%
|
| DR/TD due to all-causality AEs |
0
0%
|
| DR/TD due to treatment-related AEs |
0
0%
|
Adverse Events
| Time Frame | 8 days | |
|---|---|---|
| Adverse Event Reporting Description | The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. | |
| Arm/Group Title | Celecoxib | |
| Arm/Group Description | Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2. | |
All Cause Mortality |
||
| Celecoxib | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Celecoxib | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/80 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Celecoxib | ||
| Affected / at Risk (%) | # Events | |
| Total | 10/80 (12.5%) | |
| Gastrointestinal disorders | ||
| Diarrhoea | 1/80 (1.3%) | |
| Injury, poisoning and procedural complications | ||
| Muscle strain | 1/80 (1.3%) | |
| Investigations | ||
| Alanine aminotransferase increased | 1/80 (1.3%) | |
| Aspartate aminotransferase increased | 1/80 (1.3%) | |
| Beta 2 microglobulin urine increased | 5/80 (6.3%) | |
| Beta-N-acetyl-D-glucosaminidase increased | 3/80 (3.8%) | |
| Blood bilirubin increased | 1/80 (1.3%) | |
| Blood creatine phosphokinase increased | 3/80 (3.8%) | |
| Blood lactate dehydrogenase increased | 2/80 (2.5%) | |
| Urobilin urine present | 1/80 (1.3%) | |
| Skin and subcutaneous tissue disorders | ||
| Eczema | 1/80 (1.3%) | |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Pfizer ClinicalTrials.gov Call Center |
|---|---|
| Organization | Pfizer, Inc. |
| Phone | 1-800-718-1021 |
| ClinicalTrials.gov_Inquiries@pfizer.com |
Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT00976716
Other Study ID Numbers:
- A3191357
First Posted:
Sep 14, 2009
Last Update Posted:
Feb 2, 2021
Last Verified:
Jan 1, 2021