Trial Outcomes & Findings for Topical Ibuprofen for Delayed Onset Mulscle Soreness (NCT NCT01794923)
NCT ID: NCT01794923
Last Updated: 2021-09-30
Results Overview
Participants were asked to complete one preacher curl, using the arm that was exercised earlier to stimulate muscle soreness on movement (MSM). Upon completion of preacher curl, participants were asked to rate their degree of MSM, using an 11 point scale ranging from 0 to 10, where 0=not sore and 10=extremely sore, higher score=more severity. Change from baseline in the time-weighted sum of MSM over 0-24 hours was derived as the MSM change from baseline multiplied by time elapsed since the previous assessment and summed over all assessments from Hour 0 to Hour 24 (range: -96 to 240, higher score indicates better response).
COMPLETED
PHASE3
205 participants
Baseline, 0 to 24 hours post-Dose 1 on Day 1
2021-09-30
Participant Flow
Participant milestones
| Measure |
Placebo Combined
Placebo matched to Ibuprofen topical gel applied topically as a 4 inch strip twice daily (to match Ibuprofen twice daily regimen) or three times daily (to match Ibuprofen thrice daily regimen) on Days 1, 2 and 3.
|
Ibuprofen Twice Daily
Ibuprofen 5 percent (%) topical gel applied topically as a 4-inch strip twice daily on Day 1, 2 and 3.
|
Ibuprofen Three Times Daily
Ibuprofen 5% topical gel applied topically as a 4 inch strip three times daily on Day 1, 2 and 3.
|
|---|---|---|---|
|
Overall Study
STARTED
|
83
|
60
|
62
|
|
Overall Study
COMPLETED
|
83
|
60
|
61
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo Combined
Placebo matched to Ibuprofen topical gel applied topically as a 4 inch strip twice daily (to match Ibuprofen twice daily regimen) or three times daily (to match Ibuprofen thrice daily regimen) on Days 1, 2 and 3.
|
Ibuprofen Twice Daily
Ibuprofen 5 percent (%) topical gel applied topically as a 4-inch strip twice daily on Day 1, 2 and 3.
|
Ibuprofen Three Times Daily
Ibuprofen 5% topical gel applied topically as a 4 inch strip three times daily on Day 1, 2 and 3.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
Baseline Characteristics
Topical Ibuprofen for Delayed Onset Mulscle Soreness
Baseline characteristics by cohort
| Measure |
Placebo Combined
n=83 Participants
Placebo matched to Ibuprofen topical gel applied topically as a 4 inch strip twice daily (to match Ibuprofen twice daily regimen) or three times daily (to match Ibuprofen thrice daily regimen) on Days 1, 2 and 3.
|
Ibuprofen Twice Daily
n=60 Participants
Ibuprofen 5 percent (%) topical gel applied topically as a 4-inch strip twice daily on Day 1, 2 and 3.
|
Ibuprofen Three Times Daily
n=62 Participants
Ibuprofen 5% topical gel applied topically as a 4 inch strip three times daily on Day 1, 2 and 3.
|
Total
n=205 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
41.1 years
STANDARD_DEVIATION 14.79 • n=93 Participants
|
44.4 years
STANDARD_DEVIATION 13.19 • n=4 Participants
|
45.5 years
STANDARD_DEVIATION 13.08 • n=27 Participants
|
43.4 years
STANDARD_DEVIATION 13.91 • n=483 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=93 Participants
|
41 Participants
n=4 Participants
|
41 Participants
n=27 Participants
|
137 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
68 Participants
n=483 Participants
|
|
Muscle Soreness with Movement (MSM)
|
7.7 units on a scale
STANDARD_DEVIATION 1.21 • n=93 Participants
|
7.6 units on a scale
STANDARD_DEVIATION 1.09 • n=4 Participants
|
7.4 units on a scale
STANDARD_DEVIATION 1.11 • n=27 Participants
|
7.6 units on a scale
STANDARD_DEVIATION 1.15 • n=483 Participants
|
|
Stiffness during Muscle Soreness with Movement (SMSM)
|
7.5 units on a scale
STANDARD_DEVIATION 1.32 • n=93 Participants
|
7.6 units on a scale
STANDARD_DEVIATION 1.18 • n=4 Participants
|
7.4 units on a scale
STANDARD_DEVIATION 1.28 • n=27 Participants
|
7.5 units on a scale
STANDARD_DEVIATION 1.26 • n=483 Participants
|
|
Spontaneous Muscle Soreness (SMS)
|
7.1 units on a scale
STANDARD_DEVIATION 1.16 • n=93 Participants
|
7.1 units on a scale
STANDARD_DEVIATION 1.13 • n=4 Participants
|
7.3 units on a scale
STANDARD_DEVIATION 1.16 • n=27 Participants
|
7.2 units on a scale
STANDARD_DEVIATION 1.15 • n=483 Participants
|
PRIMARY outcome
Timeframe: Baseline, 0 to 24 hours post-Dose 1 on Day 1Population: Full analysis set population included all randomized participants who were dosed with the study medication and provided a baseline assessment.
Participants were asked to complete one preacher curl, using the arm that was exercised earlier to stimulate muscle soreness on movement (MSM). Upon completion of preacher curl, participants were asked to rate their degree of MSM, using an 11 point scale ranging from 0 to 10, where 0=not sore and 10=extremely sore, higher score=more severity. Change from baseline in the time-weighted sum of MSM over 0-24 hours was derived as the MSM change from baseline multiplied by time elapsed since the previous assessment and summed over all assessments from Hour 0 to Hour 24 (range: -96 to 240, higher score indicates better response).
Outcome measures
| Measure |
Placebo Combined
n=83 Participants
Placebo matched to Ibuprofen topical gel applied topically as a 4 inch strip twice daily (to match Ibuprofen twice daily regimen) or three times daily (to match Ibuprofen thrice daily regimen) on Days 1, 2 and 3.
|
Ibuprofen Twice Daily
n=60 Participants
Ibuprofen 5 percent (%) topical gel applied topically as a 4-inch strip twice daily on Day 1, 2 and 3.
|
Ibuprofen Three Times Daily
n=62 Participants
Ibuprofen 5% topical gel applied topically as a 4 inch strip three times daily on Day 1, 2 and 3.
|
|---|---|---|---|
|
Change From Baseline in the Time-Weighted Sum of Muscle Soreness With Movement Over 0-24 Hours Post-Dose 1 (MSM 0-24 )
|
22.2 units on a scale
Standard Error 4.46
|
17.8 units on a scale
Standard Error 5.12
|
29.7 units on a scale
Standard Error 5.00
|
SECONDARY outcome
Timeframe: Baseline, 24 to 48, 48 to 72, 0 to 72 hours post-Dose 1 on Day 1Population: Full analysis set included all randomized participants who were dosed with the study medication and provided a baseline assessment.
Participants were asked to complete one preacher curl, using the arm that was exercised earlier to stimulate MSM. Upon completion of preacher curl, participants were asked to rate their degree of MSM, using an 11-point scale ranging from 0 to 10, where 0=not sore and 10=extremely sore, higher scores=more severity. Change from baseline in the time-weighted sum of MSM over 24-48 hours, 48-72 hours and 0-72 hours were derived as the MSM change from baseline multiplied by time elapsed since the previous assessment and summed over all assessments from Hour 24 to Hour 48 (range: -96 to 240, higher score indicates better response); Hour 48 to Hour 72 (range: -96 to 240, higher score indicates better outcome); and Hour 0 to Hour 72 (range: -288 to 720, higher score indicates better response).
Outcome measures
| Measure |
Placebo Combined
n=83 Participants
Placebo matched to Ibuprofen topical gel applied topically as a 4 inch strip twice daily (to match Ibuprofen twice daily regimen) or three times daily (to match Ibuprofen thrice daily regimen) on Days 1, 2 and 3.
|
Ibuprofen Twice Daily
n=60 Participants
Ibuprofen 5 percent (%) topical gel applied topically as a 4-inch strip twice daily on Day 1, 2 and 3.
|
Ibuprofen Three Times Daily
n=62 Participants
Ibuprofen 5% topical gel applied topically as a 4 inch strip three times daily on Day 1, 2 and 3.
|
|---|---|---|---|
|
Change From Baseline in the Time-Weighted Sum of Muscle Soreness With Movement Over 24-48 Hours, 48-72 Hours, 0-72 Hours Post-Dose 1
28-48 hours
|
78.3 units on a scale
Standard Error 9.14
|
81.0 units on a scale
Standard Error 10.49
|
85.4 units on a scale
Standard Error 10.25
|
|
Change From Baseline in the Time-Weighted Sum of Muscle Soreness With Movement Over 24-48 Hours, 48-72 Hours, 0-72 Hours Post-Dose 1
48-72 hours
|
149.6 units on a scale
Standard Error 10.06
|
150.5 units on a scale
Standard Error 11.54
|
135.6 units on a scale
Standard Error 11.27
|
|
Change From Baseline in the Time-Weighted Sum of Muscle Soreness With Movement Over 24-48 Hours, 48-72 Hours, 0-72 Hours Post-Dose 1
0-72 hours
|
194.6 units on a scale
Standard Error 16.26
|
191.9 units on a scale
Standard Error 18.66
|
191.4 units on a scale
Standard Error 18.22
|
SECONDARY outcome
Timeframe: Baseline,1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 hours post-Dose 1 on Day 1Population: Full analysis set included all randomized participants who were dosed with the study medication and provided a baseline assessment.
Participants were asked to complete one preacher curl, using the arm that was exercised earlier to stimulate MSM. Upon completion of preacher curl, participants were asked to rate their degree of MSM, using an 11-point scale ranging from 0 to 10, where 0=not sore' and 10=extremely sore, higher score=more severity.
Outcome measures
| Measure |
Placebo Combined
n=83 Participants
Placebo matched to Ibuprofen topical gel applied topically as a 4 inch strip twice daily (to match Ibuprofen twice daily regimen) or three times daily (to match Ibuprofen thrice daily regimen) on Days 1, 2 and 3.
|
Ibuprofen Twice Daily
n=60 Participants
Ibuprofen 5 percent (%) topical gel applied topically as a 4-inch strip twice daily on Day 1, 2 and 3.
|
Ibuprofen Three Times Daily
n=62 Participants
Ibuprofen 5% topical gel applied topically as a 4 inch strip three times daily on Day 1, 2 and 3.
|
|---|---|---|---|
|
Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1
1 hour
|
-0.0 units on a scale
Standard Error 0.10
|
-0.1 units on a scale
Standard Error 0.11
|
-0.2 units on a scale
Standard Error 0.11
|
|
Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1
2 hours
|
0.1 units on a scale
Standard Error 0.11
|
-0.2 units on a scale
Standard Error 0.12
|
-0.0 units on a scale
Standard Error 0.12
|
|
Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1
3 hours
|
0.2 units on a scale
Standard Error 0.13
|
-0.1 units on a scale
Standard Error 0.15
|
0.1 units on a scale
Standard Error 0.15
|
|
Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1
4 hours
|
0.4 units on a scale
Standard Error 0.16
|
0.0 units on a scale
Standard Error 0.18
|
0.2 units on a scale
Standard Error 0.18
|
|
Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1
5 hours
|
0.5 units on a scale
Standard Error 0.16
|
0.1 units on a scale
Standard Error 0.19
|
0.3 units on a scale
Standard Error 0.18
|
|
Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1
6 hours
|
0.5 units on a scale
Standard Error 0.18
|
0.2 units on a scale
Standard Error 0.21
|
0.5 units on a scale
Standard Error 0.21
|
|
Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1
7 hours
|
0.7 units on a scale
Standard Error 0.19
|
0.3 units on a scale
Standard Error 0.22
|
0.7 units on a scale
Standard Error 0.22
|
|
Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1
8 hours
|
0.7 units on a scale
Standard Error 0.20
|
0.4 units on a scale
Standard Error 0.23
|
0.7 units on a scale
Standard Error 0.22
|
|
Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1
9 hours
|
0.7 units on a scale
Standard Error 0.21
|
0.3 units on a scale
Standard Error 0.24
|
0.1 units on a scale
Standard Error 0.23
|
|
Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1
10 hours
|
0.9 units on a scale
Standard Error 0.21
|
0.5 units on a scale
Standard Error 0.25
|
1.1 units on a scale
Standard Error 0.24
|
|
Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1
11 hours
|
0.8 units on a scale
Standard Error 0.21
|
0.5 units on a scale
Standard Error 0.24
|
1.1 units on a scale
Standard Error 0.23
|
|
Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1
12 hours
|
0.9 units on a scale
Standard Error 0.22
|
0.6 units on a scale
Standard Error 0.25
|
1.2 units on a scale
Standard Error 0.25
|
|
Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1
24 hours
|
1.3 units on a scale
Standard Error 0.26
|
1.3 units on a scale
Standard Error 0.29
|
1.9 units on a scale
Standard Error 0.29
|
|
Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1
30 hours
|
1.7 units on a scale
Standard Error 0.26
|
1.7 units on a scale
Standard Error 0.30
|
2.0 units on a scale
Standard Error 0.29
|
|
Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1
36 hours
|
2.1 units on a scale
Standard Error 0.28
|
2.2 units on a scale
Standard Error 0.33
|
2.3 units on a scale
Standard Error 0.32
|
|
Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1
48 hours
|
3.3 units on a scale
Standard Error 0.29
|
3.5 units on a scale
Standard Error 0.33
|
3.0 units on a scale
Standard Error 0.33
|
|
Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1
54 hours
|
3.7 units on a scale
Standard Error 0.30
|
3.6 units on a scale
Standard Error 0.34
|
3.5 units on a scale
Standard Error 0.33
|
|
Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1
60 hours
|
4.2 units on a scale
Standard Error 0.30
|
4.2 units on a scale
Standard Error 0.34
|
3.9 units on a scale
Standard Error 0.33
|
|
Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1
72 hours
|
5.2 units on a scale
Standard Error 0.29
|
5.1 units on a scale
Standard Error 0.33
|
4.6 units on a scale
Standard Error 0.32
|
SECONDARY outcome
Timeframe: Baseline, 24 to 48, 48 to 72, 0 to 72 hours post-Dose 1 on Day 1Population: Full analysis set included all randomized participants who were dosed with the study medication and provided a baseline assessment.
Participants after sitting quietly for 3 minutes, were asked to extend the arm that was exercised earlier to stimulate MSM. Participants were asked to rate their degree of SMS, using an 11-point scale ranging from 0 to 10, where 0=not sore and 10=extremely sore, higher score=more severity. Change from baseline in time-weighted sum of SMS over 0-24 hours (hr.), 24-48 hr., 48-72 hr. and 0-72 hr. were derived as the SMS change from baseline multiplied by time elapsed since the previous assessment and summed overall assessment from Hour 0 to Hour 24 (range: -240 to 240, higher score indicates better response), Hour 24 to Hour 48 (range: -240 to 240, higher score indicates better response); Hour 48 to Hour 72 (range: -240 to 240, higher score indicates better response); and Hour 0 to Hour 72 (range: -720 to 720, higher score indicates better response).
Outcome measures
| Measure |
Placebo Combined
n=83 Participants
Placebo matched to Ibuprofen topical gel applied topically as a 4 inch strip twice daily (to match Ibuprofen twice daily regimen) or three times daily (to match Ibuprofen thrice daily regimen) on Days 1, 2 and 3.
|
Ibuprofen Twice Daily
n=60 Participants
Ibuprofen 5 percent (%) topical gel applied topically as a 4-inch strip twice daily on Day 1, 2 and 3.
|
Ibuprofen Three Times Daily
n=62 Participants
Ibuprofen 5% topical gel applied topically as a 4 inch strip three times daily on Day 1, 2 and 3.
|
|---|---|---|---|
|
Change From Baseline in the Time-weighted Sum of Spontaneous Muscle Soreness Over 0-24 Hours, 24-48 Hours, 48-72 Hours, and 0-72 Hours Post-Dose 1
0-24 hours
|
21.8 units on a scale
Standard Error 4.50
|
18.7 units on a scale
Standard Error 5.23
|
24.6 units on a scale
Standard Error 5.37
|
|
Change From Baseline in the Time-weighted Sum of Spontaneous Muscle Soreness Over 0-24 Hours, 24-48 Hours, 48-72 Hours, and 0-72 Hours Post-Dose 1
24-48 hours
|
77.3 units on a scale
Standard Error 8.95
|
78.0 units on a scale
Standard Error 10.41
|
73.1 units on a scale
Standard Error 10.69
|
|
Change From Baseline in the Time-weighted Sum of Spontaneous Muscle Soreness Over 0-24 Hours, 24-48 Hours, 48-72 Hours, and 0-72 Hours Post-Dose 1
48-72 hours
|
143.9 units on a scale
Standard Error 9.64
|
146.0 units on a scale
Standard Error 11.20
|
124.9 units on a scale
Standard Error 11.50
|
|
Change From Baseline in the Time-weighted Sum of Spontaneous Muscle Soreness Over 0-24 Hours, 24-48 Hours, 48-72 Hours, and 0-72 Hours Post-Dose 1
0-72 hours
|
188.7 units on a scale
Standard Error 15.83
|
187.7 units on a scale
Standard Error 18.40
|
170.8 units on a scale
Standard Error 18.89
|
SECONDARY outcome
Timeframe: Baseline,1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 hours post-Dose 1 on Day 1Population: Full analysis set included all randomized participants who were dosed with the study medication and provided a baseline assessment.
Participants after sitting quietly for 3 minutes, were asked to extend the arm that was exercised earlier to stimulate SMS. Participants were asked to rate their degree of SMS, using an 11-point scale ranging from 0 to 10, where 0=not sore and 10=extremely sore, higher score=more severity.
Outcome measures
| Measure |
Placebo Combined
n=83 Participants
Placebo matched to Ibuprofen topical gel applied topically as a 4 inch strip twice daily (to match Ibuprofen twice daily regimen) or three times daily (to match Ibuprofen thrice daily regimen) on Days 1, 2 and 3.
|
Ibuprofen Twice Daily
n=60 Participants
Ibuprofen 5 percent (%) topical gel applied topically as a 4-inch strip twice daily on Day 1, 2 and 3.
|
Ibuprofen Three Times Daily
n=62 Participants
Ibuprofen 5% topical gel applied topically as a 4 inch strip three times daily on Day 1, 2 and 3.
|
|---|---|---|---|
|
Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1
54 hours
|
3.7 units on a scale
Standard Error 0.29
|
3.6 units on a scale
Standard Error 0.33
|
3.2 units on a scale
Standard Error 0.34
|
|
Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1
1 hour
|
0.0 units on a scale
Standard Error 0.08
|
0.1 units on a scale
Standard Error 0.09
|
-0.1 units on a scale
Standard Error 0.10
|
|
Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1
2 hours
|
0.1 units on a scale
Standard Error 0.10
|
-0.0 units on a scale
Standard Error 0.11
|
-0.2 units on a scale
Standard Error 0.12
|
|
Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1
3 hours
|
0.2 units on a scale
Standard Error 0.13
|
0.1 units on a scale
Standard Error 0.15
|
-0.1 units on a scale
Standard Error 0.16
|
|
Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1
4 hours
|
0.4 units on a scale
Standard Error 0.15
|
0.2 units on a scale
Standard Error 0.17
|
0.1 units on a scale
Standard Error 0.18
|
|
Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1
5 hours
|
0.4 units on a scale
Standard Error 0.17
|
0.2 units on a scale
Standard Error 0.19
|
0.3 units on a scale
Standard Error 0.20
|
|
Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1
6 hours
|
0.5 units on a scale
Standard Error 0.18
|
0.3 units on a scale
Standard Error 0.21
|
0.4 units on a scale
Standard Error 0.22
|
|
Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1
7 hours
|
0.7 units on a scale
Standard Error 0.19
|
0.4 units on a scale
Standard Error 0.22
|
0.7 units on a scale
Standard Error 0.23
|
|
Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1
8 hours
|
0.8 units on a scale
Standard Error 0.20
|
0.5 units on a scale
Standard Error 0.23
|
0.8 units on a scale
Standard Error 0.24
|
|
Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1
9 hours
|
0.8 units on a scale
Standard Error 0.21
|
0.6 units on a scale
Standard Error 0.24
|
1.0 units on a scale
Standard Error 0.25
|
|
Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1
10 hours
|
0.9 units on a scale
Standard Error 0.21
|
0.6 units on a scale
Standard Error 0.24
|
1.0 units on a scale
Standard Error 0.25
|
|
Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1
11 hours
|
0.9 units on a scale
Standard Error 0.22
|
0.6 units on a scale
Standard Error 0.25
|
1.1 units on a scale
Standard Error 0.26
|
|
Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1
12 hours
|
0.9 units on a scale
Standard Error 0.22
|
0.7 units on a scale
Standard Error 0.25
|
1.2 units on a scale
Standard Error 0.26
|
|
Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1
24 hours
|
1.3 units on a scale
Standard Error 0.26
|
1.2 units on a scale
Standard Error 0.30
|
1.5 units on a scale
Standard Error 031
|
|
Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1
30 hours
|
1.7 units on a scale
Standard Error 0.26
|
1.7 units on a scale
Standard Error 0.30
|
1.6 units on a scale
Standard Error 0.31
|
|
Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1
36 hours
|
2.2 units on a scale
Standard Error 0.28
|
2.1 units on a scale
Standard Error 0.32
|
1.9 units on a scale
Standard Error 0.33
|
|
Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1
48 hours
|
3.2 units on a scale
Standard Error 0.28
|
3.4 units on a scale
Standard Error 0.32
|
2.8 units on a scale
Standard Error 0.33
|
|
Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1
60 hours
|
4.0 units on a scale
Standard Error 0.29
|
4.1 units on a scale
Standard Error 0.33
|
3.5 units on a scale
Standard Error 0.34
|
|
Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1
72 hours
|
4.9 units on a scale
Standard Error 0.28
|
4.9 units on a scale
Standard Error 0.32
|
4.3 units on a scale
Standard Error 0.33
|
SECONDARY outcome
Timeframe: 0 to 24, 24 to 48, 48 to 72 and 0 to 72 hours on Day 1Population: Full analysis set included all randomized participants who were dosed with the study medication and provided a baseline assessment.
Participants were asked: "Which phrase best describes the relief of muscle soreness which you are experiencing?" Participant's response were recorded using a five-point scale: 0=None, 1=A little, 2=Some, 3=A lot and 4=Complete relief. Time-weighted sum of muscle soreness relief over 0-24 hours, 24-48 hours, 48-72 hours, and 0-72 hours were derived as the muscle soreness relief score multiplied by time elapsed since the previous assessment and summed over all assessments from Hour 0 to Hour 24 (total score range: 0 \[none\] to 96 \[complete relief\], higher score indicates better response), Hour 24 to Hour 48 (range: 0 to 96, higher score indicates better response); Hour 48 to Hour 72 (range: 0 to 96, higher score indicates better response); and Hour 0 to Hour 72 (range: 0 to 288, higher score indicates better response).
Outcome measures
| Measure |
Placebo Combined
n=83 Participants
Placebo matched to Ibuprofen topical gel applied topically as a 4 inch strip twice daily (to match Ibuprofen twice daily regimen) or three times daily (to match Ibuprofen thrice daily regimen) on Days 1, 2 and 3.
|
Ibuprofen Twice Daily
n=60 Participants
Ibuprofen 5 percent (%) topical gel applied topically as a 4-inch strip twice daily on Day 1, 2 and 3.
|
Ibuprofen Three Times Daily
n=62 Participants
Ibuprofen 5% topical gel applied topically as a 4 inch strip three times daily on Day 1, 2 and 3.
|
|---|---|---|---|
|
Time-weighted Sum of Muscle Soreness Relief Over 0-24 Hours, 24-48 Hours, 48-72 Hours, and 0-72 Hours
0-24 hours
|
18.8 units on a scale
Standard Error 2.26
|
16.8 units on a scale
Standard Error 2.64
|
23.4 units on a scale
Standard Error 2.61
|
|
Time-weighted Sum of Muscle Soreness Relief Over 0-24 Hours, 24-48 Hours, 48-72 Hours, and 0-72 Hours
24-48 hours
|
57.3 units on a scale
Standard Error 4.31
|
56.4 units on a scale
Standard Error 5.04
|
58.4 units on a scale
Standard Error 4.98
|
|
Time-weighted Sum of Muscle Soreness Relief Over 0-24 Hours, 24-48 Hours, 48-72 Hours, and 0-72 Hours
48-72 hours
|
90.5 units on a scale
Standard Error 4.19
|
92.5 units on a scale
Standard Error 4.89
|
82.3 units on a scale
Standard Error 4.83
|
|
Time-weighted Sum of Muscle Soreness Relief Over 0-24 Hours, 24-48 Hours, 48-72 Hours, and 0-72 Hours
0-72 hours
|
128.6 units on a scale
Standard Error 7.18
|
127.2 units on a scale
Standard Error 8.39
|
124.4 units on a scale
Standard Error 8.29
|
SECONDARY outcome
Timeframe: Baseline, 24 hours post-Dose 1Population: Full analysis set included all randomized participants who were dosed with the study medication and provided a baseline assessment.
Participants were asked to rate their SMSM, using an 11-point scale, with 0=not stiff and 10=extremely stiff, higher score indicated more severity.
Outcome measures
| Measure |
Placebo Combined
n=83 Participants
Placebo matched to Ibuprofen topical gel applied topically as a 4 inch strip twice daily (to match Ibuprofen twice daily regimen) or three times daily (to match Ibuprofen thrice daily regimen) on Days 1, 2 and 3.
|
Ibuprofen Twice Daily
n=60 Participants
Ibuprofen 5 percent (%) topical gel applied topically as a 4-inch strip twice daily on Day 1, 2 and 3.
|
Ibuprofen Three Times Daily
n=62 Participants
Ibuprofen 5% topical gel applied topically as a 4 inch strip three times daily on Day 1, 2 and 3.
|
|---|---|---|---|
|
Change From Baseline in Stiffness During Muscle Soreness With Movement (SMSM) Assessment at 24 Hours Post-Dose 1
|
1.6 units on a scale
Standard Error 0.31
|
1.7 units on a scale
Standard Error 0.37
|
2.1 units on a scale
Standard Error 0.36
|
SECONDARY outcome
Timeframe: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 hours post-Dose 1 on Day 1Population: Full analysis set included all randomized participants who were dosed with the study medication and provided a baseline assessment.
Participants were asked: "Which phrase best describes the relief of muscle soreness which you are experiencing?" Participant's response was recorded using a five-point scale: 0 = None, 1 = A little, 2 = Some, 3 = A lot and 4 = Complete, higher scores indicated better response/more relief.
Outcome measures
| Measure |
Placebo Combined
n=83 Participants
Placebo matched to Ibuprofen topical gel applied topically as a 4 inch strip twice daily (to match Ibuprofen twice daily regimen) or three times daily (to match Ibuprofen thrice daily regimen) on Days 1, 2 and 3.
|
Ibuprofen Twice Daily
n=60 Participants
Ibuprofen 5 percent (%) topical gel applied topically as a 4-inch strip twice daily on Day 1, 2 and 3.
|
Ibuprofen Three Times Daily
n=62 Participants
Ibuprofen 5% topical gel applied topically as a 4 inch strip three times daily on Day 1, 2 and 3.
|
|---|---|---|---|
|
Muscle Soreness Relief at Each Time Point
10 hours
|
0.7 units on a scale
Standard Error 0.11
|
0.7 units on a scale
Standard Error 0.13
|
1.0 units on a scale
Standard Error 0.13
|
|
Muscle Soreness Relief at Each Time Point
11 hours
|
0.7 units on a scale
Standard Error 0.11
|
0.7 units on a scale
Standard Error 0.13
|
1.0 units on a scale
Standard Error 0.13
|
|
Muscle Soreness Relief at Each Time Point
12 hours
|
0.7 units on a scale
Standard Error 0.11
|
0.7 units on a scale
Standard Error 0.13
|
1.0 units on a scale
Standard Error 0.13
|
|
Muscle Soreness Relief at Each Time Point
24 hours
|
1.0 units on a scale
Standard Error 0.14
|
0.9 units on a scale
Standard Error 0.16
|
1.3 units on a scale
Standard Error 0.16
|
|
Muscle Soreness Relief at Each Time Point
30 hours
|
1.4 units on a scale
Standard Error 0.14
|
1.3 units on a scale
Standard Error 0.16
|
1.4 units on a scale
Standard Error 0.16
|
|
Muscle Soreness Relief at Each Time Point
1 hour
|
0.1 units on a scale
Standard Error 0.04
|
0.1 units on a scale
Standard Error 0.05
|
0.0 units on a scale
Standard Error 0.05
|
|
Muscle Soreness Relief at Each Time Point
2 hours
|
0.2 units on a scale
Standard Error 0.05
|
0.2 units on a scale
Standard Error 0.05
|
0.2 units on a scale
Standard Error 0.05
|
|
Muscle Soreness Relief at Each Time Point
3 hours
|
0.3 units on a scale
Standard Error 0.07
|
0.2 units on a scale
Standard Error 0.08
|
0.3 units on a scale
Standard Error 0.08
|
|
Muscle Soreness Relief at Each Time Point
4 hours
|
0.5 units on a scale
Standard Error 0.08
|
0.4 units on a scale
Standard Error 0.10
|
0.4 units on a scale
Standard Error 0.10
|
|
Muscle Soreness Relief at Each Time Point
5 hours
|
0.5 units on a scale
Standard Error 0.08
|
0.3 units on a scale
Standard Error 0.10
|
0.5 units on a scale
Standard Error 0.10
|
|
Muscle Soreness Relief at Each Time Point
6 hours
|
0.5 units on a scale
Standard Error 0.10
|
0.5 units on a scale
Standard Error 0.11
|
0.7 units on a scale
Standard Error 0.11
|
|
Muscle Soreness Relief at Each Time Point
7 hours
|
0.6 units on a scale
Standard Error 0.10
|
0.5 units on a scale
Standard Error 0.11
|
0.7 units on a scale
Standard Error 0.11
|
|
Muscle Soreness Relief at Each Time Point
8 hours
|
0.6 units on a scale
Standard Error 0.10
|
0.6 units on a scale
Standard Error 0.12
|
0.7 units on a scale
Standard Error 0.12
|
|
Muscle Soreness Relief at Each Time Point
9 hours
|
0.7 units on a scale
Standard Error 0.10
|
0.6 units on a scale
Standard Error 0.12
|
0.9 units on a scale
Standard Error 0.12
|
|
Muscle Soreness Relief at Each Time Point
36 hours
|
1.8 units on a scale
Standard Error 0.14
|
1.6 units on a scale
Standard Error 0.16
|
1.7 units on a scale
Standard Error 0.16
|
|
Muscle Soreness Relief at Each Time Point
48 hours
|
2.1 units on a scale
Standard Error 0.13
|
2.3 units on a scale
Standard Error 0.15
|
2.0 units on a scale
Standard Error 0.15
|
|
Muscle Soreness Relief at Each Time Point
54 hours
|
2.4 units on a scale
Standard Error 0.13
|
2.3 units on a scale
Standard Error 0.15
|
2.2 units on a scale
Standard Error 0.15
|
|
Muscle Soreness Relief at Each Time Point
60 hours
|
2.6 units on a scale
Standard Error 0.13
|
2.5 units on a scale
Standard Error 0.15
|
2.4 units on a scale
Standard Error 0.15
|
|
Muscle Soreness Relief at Each Time Point
72 hours
|
2.9 units on a scale
Standard Error 0.13
|
3.0 units on a scale
Standard Error 0.15
|
2.6 units on a scale
Standard Error 0.15
|
SECONDARY outcome
Timeframe: Day 4Population: Full analysis set included all randomized participants who were dosed with the study medication and provided a baseline assessment.
Participants were asked the following question: "How would you rate this medication as a pain reliever?" Participant's response was recorded using a five point scale: 1 = Very Poor, 2 = Poor, 3 = Fair, 4 = Good, 5 = Very Good, where higher score indicated better response.
Outcome measures
| Measure |
Placebo Combined
n=83 Participants
Placebo matched to Ibuprofen topical gel applied topically as a 4 inch strip twice daily (to match Ibuprofen twice daily regimen) or three times daily (to match Ibuprofen thrice daily regimen) on Days 1, 2 and 3.
|
Ibuprofen Twice Daily
n=60 Participants
Ibuprofen 5 percent (%) topical gel applied topically as a 4-inch strip twice daily on Day 1, 2 and 3.
|
Ibuprofen Three Times Daily
n=62 Participants
Ibuprofen 5% topical gel applied topically as a 4 inch strip three times daily on Day 1, 2 and 3.
|
|---|---|---|---|
|
Participant's Global Assessment of Medication at Day 4
|
2.3 units on a scale
Standard Deviation 1.08
|
2.4 units on a scale
Standard Deviation 1.15
|
2.2 units on a scale
Standard Deviation 1.19
|
SECONDARY outcome
Timeframe: Baseline up to Day 4Population: Full analysis set included all randomized participants who were dosed with the study medication and provided a baseline assessment.
Acetaminophen 500 milligram (mg) every 6 hours as needed was used as rescue analgesia/therapy during the course of the study.
Outcome measures
| Measure |
Placebo Combined
n=83 Participants
Placebo matched to Ibuprofen topical gel applied topically as a 4 inch strip twice daily (to match Ibuprofen twice daily regimen) or three times daily (to match Ibuprofen thrice daily regimen) on Days 1, 2 and 3.
|
Ibuprofen Twice Daily
n=60 Participants
Ibuprofen 5 percent (%) topical gel applied topically as a 4-inch strip twice daily on Day 1, 2 and 3.
|
Ibuprofen Three Times Daily
n=62 Participants
Ibuprofen 5% topical gel applied topically as a 4 inch strip three times daily on Day 1, 2 and 3.
|
|---|---|---|---|
|
Percentage of Participants Taking Rescue Medication
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 4Population: Due to change in conduct of study no rescue medication was use, therefore data for this outcome measure was not collected and analyzed.
Time to first us of rescue medication was defined as time (in hours) from a dose of study medication to the first use of recue medication and was censored at the time of the next dose of study medication, or at 12 hours after the final application of the study medication. Acetaminophen 500 milligram (mg) every 6 hours as needed was used as rescue analgesia/therapy during the course of the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to Day 4Population: Due to change in conduct of study no rescue medication was use, therefore data for this outcome measure was not collected and analyzed.
Acetaminophen 500 milligram (mg) every 6 hours as needed was used as rescue analgesia/therapy during the course of the study.
Outcome measures
Outcome data not reported
Adverse Events
Placebo Combined
Ibuprofen Twice Daily
Ibuprofen Three Times Daily
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo Combined
n=83 participants at risk
Placebo matched to Ibuprofen topical gel applied topically as a 4 inch strip twice daily (to match Ibuprofen twice daily regimen) or three times daily (to match Ibuprofen thrice daily regimen) on Days 1, 2 and 3.
|
Ibuprofen Twice Daily
n=60 participants at risk
Ibuprofen 5 percent (%) topical gel applied topically as a 4-inch strip twice daily on Day 1, 2 and 3.
|
Ibuprofen Three Times Daily
n=62 participants at risk
Ibuprofen 5% topical gel applied topically as a 4 inch strip three times daily on Day 1, 2 and 3.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/83
|
0.00%
0/60
|
1.6%
1/62
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/83
|
0.00%
0/60
|
6.5%
4/62
|
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