Trial Outcomes & Findings for Assess the Efficacy and Safety in Volunteers of DCF100, TIB200 and SPR300 vs. Placebo and Control(s) in a UV Pain Model (NCT NCT02666846)
NCT ID: NCT02666846
Last Updated: 2021-01-27
Results Overview
To assess the pharmacodynamic effect by Heat Pain Tolerance Test (HPTT) which measured the point at which the heat became painful (degrees centigrade) of three topical analgesics, DCF100, TIB200, and SPR300 versus topical placebo and active topical reference products in a model of UV-induced inflammatory pain.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
60 participants
Primary outcome timeframe
15 minutes before to 6 hours post administration
Results posted on
2021-01-27
Participant Flow
Participant milestones
| Measure |
Cohort 1 (Dosed on Days 1, 2 and 3)
All Cohort 1 participants: Ibuprofen (day 1), TIB200 gel (10%, w/w) (Day 2) and TIB200 (placebo gel) (Day 3)
(Follow up 7-9 days post last UVB irradiation)
Ibuprofen: Single topical dose per 1.76 cm2 test site of: 22 microliters (μL) (20 ± l mg)\* of TIB200 Gel (ibuprofen 10% w/w) (Test Gel) or 22 μL (20 ± l mg)\* of matching placebo TIB200 Gel (placebo gel) or 22 μL (20 ± l mg)\* of Nurofen Maximum Strength Gel (ibuprofen 10% w/w) (reference gel).
|
Cohort 2 (Dosed on Days 1,2,3 and 4)
All Cohort 2 Participants: Diclofenac, DCF100 gel (2% w/w) (day 1), DCF100 gel (4% w/w) (day 2), DCF100 gel (marching placebo) Day 3 and Voltarol® 12 Hour Emulgel® P 2.32% Gel (day 4)
(Follow up 7-9 days post last UVB irradiation)
Diclofenac: Subjects were randomised to receive 22 uL (20 ± l mg) DCF100 Gel (diclofenac 2% w/w) / DCF100 Gel (diclofenac 4% w/w) / Matching Placebo DCF100 Gel / Voltarol® 12 Hour Emulgel® P 2.32% Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 3 (Dosed on Days 1 and 2)
All Cohort 3 Participants: Methyl-salicylate / Menthol, SPR300 gel (15%:7%, w/w; ratio of Methylsalicylate / Menthol) (day 1) and SPR300 (Matching Placebo) (day 2)
Follow up visit between days 7-9 post last UVB irradiation
Methyl-salicylate / Menthol: Subjects were randomised to receive 22 uL (20 ± l mg) SPR300 Gel / Matching Placebo SPR300 Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
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|---|---|---|---|
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Overall Study
STARTED
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
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0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assess the Efficacy and Safety in Volunteers of DCF100, TIB200 and SPR300 vs. Placebo and Control(s) in a UV Pain Model
Baseline characteristics by cohort
| Measure |
Cohort 1
n=20 Participants
Cohort 1:
Ibuprofen: Single topical dose per 1.76 cm2 test site of: 22 microliters (μL) (20 ± l mg)\* of TIB200 Gel (ibuprofen 10% w/w) (Test Gel) or 22 μL (20 ± l mg)\* of matching placebo TIB200 Gel (placebo gel) or 22 μL (20 ± l mg)\* of Nurofen Maximum Strength Gel (ibuprofen 10% w/w) (reference gel) or Ibuprofen, Nurofen oral tablets (2 x 400 mg)
|
Cohort 2:
n=20 Participants
Cohort 2:
Diclofenac: Subjects were randomised to receive 22 uL (20 ± l mg) DCF100 Gel (diclofenac 2% w/w) / DCF100 Gel (diclofenac 4% w/w) / Matching Placebo DCF100 Gel / Voltarol® 12 Hour Emulgel® P 2.32% Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 3
n=20 Participants
Cohort 3:
Methyl-salicylate / Menthol: Subjects were randomised to receive 22 uL (20 ± l mg) SPR300 Gel / Matching Placebo SPR300 Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Total
n=60 Participants
Total of all reporting groups
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|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
60 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
60 Participants
n=483 Participants
|
|
Region of Enrollment
United Kingdom
|
20 participants
n=93 Participants
|
20 participants
n=4 Participants
|
20 participants
n=27 Participants
|
20 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 15 minutes before to 6 hours post administrationTo assess the pharmacodynamic effect by Heat Pain Tolerance Test (HPTT) which measured the point at which the heat became painful (degrees centigrade) of three topical analgesics, DCF100, TIB200, and SPR300 versus topical placebo and active topical reference products in a model of UV-induced inflammatory pain.
Outcome measures
| Measure |
Cohort 1: Nurofen Gel 10%
n=20 Participants
Cohort 1: Ibuprofen, Nurofen Max Strength gel (10%, w/w)
Ibuprofen: Single topical dose per 1.76 cm2 test site of: 22 microliters (μL) (20 ± l mg)\* of TIB200 Gel (ibuprofen 10% w/w) (Test Gel) or 22 μL (20 ± l mg)\* of matching placebo TIB200 Gel (placebo gel) or 22 μL (20 ± l mg)\* of Nurofen Maximum Strength Gel (ibuprofen 10% w/w) (reference gel).
|
Cohort 1: Nurofen Tablets
n=20 Participants
Cohort 1: Ibuprofen, Nurofen oral tablets (2 x 400 mg)
Ibuprofen: Single topical dose per 1.76 cm2 test site of: 22 microliters (μL) (20 ± l mg)\* of TIB200 Gel (ibuprofen 10% w/w) (Test Gel) or 22 μL (20 ± l mg)\* of matching placebo TIB200 Gel (placebo gel) or 22 μL (20 ± l mg)\* of Nurofen Maximum Strength Gel (ibuprofen 10% w/w) (reference gel).
|
Cohort 1: TIB200 Placebo Gel
n=20 Participants
Cohort 1: TIB200 matching placebo gel
Placebo: The placebo gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 2: DCF100 Gel 2%
n=20 Participants
Cohort 2: Diclofenac, DCF100 gel (2% w/w)
Diclofenac: Subjects were randomised to receive 22 uL (20 ± l mg) DCF100 Gel (diclofenac 2% w/w) / DCF100 Gel (diclofenac 4% w/w) / Matching Placebo DCF100 Gel / Voltarol® 12 Hour Emulgel® P 2.32% Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 2: DCF100 Gel 4%
n=20 Participants
Cohort 2: Diclofenac, DCF100 gel (4% w/w)
Diclofenac: Subjects were randomised to receive 22 uL (20 ± l mg) DCF100 Gel (diclofenac 2% w/w) / DCF100 Gel (diclofenac 4% w/w) / Matching Placebo DCF100 Gel / Voltarol® 12 Hour Emulgel® P 2.32% Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 1: TIB200 Gel 10%
n=20 Participants
Cohort 1: Ibuprofen, TIB200 gel (10%, w/w)
Ibuprofen: Single topical dose per 1.76 cm2 test site of: 22 microliters (μL) (20 ± l mg)\* of TIB200 Gel (ibuprofen 10% w/w) (Test Gel) or 22 μL (20 ± l mg)\* of matching placebo TIB200 Gel (placebo gel) or 22 μL (20 ± l mg)\* of Nurofen Maximum Strength Gel (ibuprofen 10% w/w) (reference gel).
|
Cohort 2: Voltaren Gel 2%
n=20 Participants
Cohort 2: Diclofenac, Voltaren Emulgel (2%)
Diclofenac: Subjects were randomised to receive 22 uL (20 ± l mg) DCF100 Gel (diclofenac 2% w/w) / DCF100 Gel (diclofenac 4% w/w) / Matching Placebo DCF100 Gel / Voltarol® 12 Hour Emulgel® P 2.32% Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 2: Voltarol Oral Tablet
n=20 Participants
Cohort 2: Diclofenac, Voltarol oral tablet (50 mg)
Diclofenac: Subjects were randomised to receive 22 uL (20 ± l mg) DCF100 Gel (diclofenac 2% w/w) / DCF100 Gel (diclofenac 4% w/w) / Matching Placebo DCF100 Gel / Voltarol® 12 Hour Emulgel® P 2.32% Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 2: DCF100 Placebo Gel
n=20 Participants
Cohort 2: DCF100 matching placebo gel
Placebo: The placebo gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 3: SPR300 Gel (15%:7%)
n=20 Participants
Cohort 3: Methyl-salicylate / Menthol, SPR300 gel (15%:7%, w/w; ratio of Methylsalicylate / Menthol)
Methyl-salicylate / Menthol: Subjects were randomised to receive 22 uL (20 ± l mg) SPR300 Gel / Matching Placebo SPR300 Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 3: SPR300 Placebo Gel
n=20 Participants
Cohort 3: SPR300 matching placebo gel
Placebo: The placebo gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
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|---|---|---|---|---|---|---|---|---|---|---|---|
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Heat Pain Tolerance Test (HPTT) Measured the Point at Which the Heat Became Painful - Degrees Centigrade -
|
0.7358 Degrees Centigrade
Standard Deviation 1.0277
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0.0887 Degrees Centigrade
Standard Deviation 0.9024
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-0.1983 Degrees Centigrade
Standard Deviation 0.4616
|
0.6679 Degrees Centigrade
Standard Deviation 1.0657
|
0.8722 Degrees Centigrade
Standard Deviation 1.0430
|
0.3635 Degrees Centigrade
Standard Deviation 1.0277
|
0.7978 Degrees Centigrade
Standard Deviation 0.9780
|
0.6835 Degrees Centigrade
Standard Deviation 0.7344
|
0.1688 Degrees Centigrade
Standard Deviation 0.7231
|
0.3934 Degrees Centigrade
Standard Deviation 1.2384
|
-0.0123 Degrees Centigrade
Standard Deviation 1.0103
|
PRIMARY outcome
Timeframe: 15 minutes before to 6 hours post administrationIntensity of the Ultra Violet B radiation (UVB)-induced erythema (determined by assessment of skin blood flow by laser Doppler imaging \[flux units\], up to 8 subjects per cohort) - Change from baseline
Outcome measures
| Measure |
Cohort 1: Nurofen Gel 10%
n=8 Participants
Cohort 1: Ibuprofen, Nurofen Max Strength gel (10%, w/w)
Ibuprofen: Single topical dose per 1.76 cm2 test site of: 22 microliters (μL) (20 ± l mg)\* of TIB200 Gel (ibuprofen 10% w/w) (Test Gel) or 22 μL (20 ± l mg)\* of matching placebo TIB200 Gel (placebo gel) or 22 μL (20 ± l mg)\* of Nurofen Maximum Strength Gel (ibuprofen 10% w/w) (reference gel).
|
Cohort 1: Nurofen Tablets
n=8 Participants
Cohort 1: Ibuprofen, Nurofen oral tablets (2 x 400 mg)
Ibuprofen: Single topical dose per 1.76 cm2 test site of: 22 microliters (μL) (20 ± l mg)\* of TIB200 Gel (ibuprofen 10% w/w) (Test Gel) or 22 μL (20 ± l mg)\* of matching placebo TIB200 Gel (placebo gel) or 22 μL (20 ± l mg)\* of Nurofen Maximum Strength Gel (ibuprofen 10% w/w) (reference gel).
|
Cohort 1: TIB200 Placebo Gel
n=8 Participants
Cohort 1: TIB200 matching placebo gel
Placebo: The placebo gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 2: DCF100 Gel 2%
n=8 Participants
Cohort 2: Diclofenac, DCF100 gel (2% w/w)
Diclofenac: Subjects were randomised to receive 22 uL (20 ± l mg) DCF100 Gel (diclofenac 2% w/w) / DCF100 Gel (diclofenac 4% w/w) / Matching Placebo DCF100 Gel / Voltarol® 12 Hour Emulgel® P 2.32% Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 2: DCF100 Gel 4%
n=8 Participants
Cohort 2: Diclofenac, DCF100 gel (4% w/w)
Diclofenac: Subjects were randomised to receive 22 uL (20 ± l mg) DCF100 Gel (diclofenac 2% w/w) / DCF100 Gel (diclofenac 4% w/w) / Matching Placebo DCF100 Gel / Voltarol® 12 Hour Emulgel® P 2.32% Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 1: TIB200 Gel 10%
n=8 Participants
Cohort 1: Ibuprofen, TIB200 gel (10%, w/w)
Ibuprofen: Single topical dose per 1.76 cm2 test site of: 22 microliters (μL) (20 ± l mg)\* of TIB200 Gel (ibuprofen 10% w/w) (Test Gel) or 22 μL (20 ± l mg)\* of matching placebo TIB200 Gel (placebo gel) or 22 μL (20 ± l mg)\* of Nurofen Maximum Strength Gel (ibuprofen 10% w/w) (reference gel).
|
Cohort 2: Voltaren Gel 2%
n=8 Participants
Cohort 2: Diclofenac, Voltaren Emulgel (2%)
Diclofenac: Subjects were randomised to receive 22 uL (20 ± l mg) DCF100 Gel (diclofenac 2% w/w) / DCF100 Gel (diclofenac 4% w/w) / Matching Placebo DCF100 Gel / Voltarol® 12 Hour Emulgel® P 2.32% Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 2: Voltarol Oral Tablet
n=8 Participants
Cohort 2: Diclofenac, Voltarol oral tablet (50 mg)
Diclofenac: Subjects were randomised to receive 22 uL (20 ± l mg) DCF100 Gel (diclofenac 2% w/w) / DCF100 Gel (diclofenac 4% w/w) / Matching Placebo DCF100 Gel / Voltarol® 12 Hour Emulgel® P 2.32% Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 2: DCF100 Placebo Gel
n=8 Participants
Cohort 2: DCF100 matching placebo gel
Placebo: The placebo gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 3: SPR300 Gel (15%:7%)
n=8 Participants
Cohort 3: Methyl-salicylate / Menthol, SPR300 gel (15%:7%, w/w; ratio of Methylsalicylate / Menthol)
Methyl-salicylate / Menthol: Subjects were randomised to receive 22 uL (20 ± l mg) SPR300 Gel / Matching Placebo SPR300 Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 3: SPR300 Placebo Gel
n=8 Participants
Cohort 3: SPR300 matching placebo gel
Placebo: The placebo gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
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Intensity of the UVB-induced Erythema (Determined by Assessment of Skin Blood Flow by Laser Doppler Imaging [Flux Units])
|
-171.5589 Laser doppler imaging (Flux Units)
Standard Deviation 96.6485
|
-262.0693 Laser doppler imaging (Flux Units)
Standard Deviation 88.5449
|
-95.3974 Laser doppler imaging (Flux Units)
Standard Deviation 81.4103
|
-228.3016 Laser doppler imaging (Flux Units)
Standard Deviation 183.2260
|
-278.1918 Laser doppler imaging (Flux Units)
Standard Deviation 103.7333
|
-313.3879 Laser doppler imaging (Flux Units)
Standard Deviation 105.7042
|
-198.1408 Laser doppler imaging (Flux Units)
Standard Deviation 133.2886
|
-198.1408 Laser doppler imaging (Flux Units)
Standard Deviation 211.2754
|
-45.376 Laser doppler imaging (Flux Units)
Standard Deviation 104.4476
|
12.2265 Laser doppler imaging (Flux Units)
Standard Deviation 111.1065
|
67.3931 Laser doppler imaging (Flux Units)
Standard Deviation 91.092
|
SECONDARY outcome
Timeframe: 15 minutes before and 1, 2, 4 and 6 hours post administrationMaximum observed plasma concentration (Cmax), time corresponding to occurrence of Cmax (tmax) (up to 6 subjects per cohort only) laser Doppler imaging \[flux units\], up to 6 subjects per cohort)
Outcome measures
| Measure |
Cohort 1: Nurofen Gel 10%
n=8 Participants
Cohort 1: Ibuprofen, Nurofen Max Strength gel (10%, w/w)
Ibuprofen: Single topical dose per 1.76 cm2 test site of: 22 microliters (μL) (20 ± l mg)\* of TIB200 Gel (ibuprofen 10% w/w) (Test Gel) or 22 μL (20 ± l mg)\* of matching placebo TIB200 Gel (placebo gel) or 22 μL (20 ± l mg)\* of Nurofen Maximum Strength Gel (ibuprofen 10% w/w) (reference gel).
|
Cohort 1: Nurofen Tablets
n=8 Participants
Cohort 1: Ibuprofen, Nurofen oral tablets (2 x 400 mg)
Ibuprofen: Single topical dose per 1.76 cm2 test site of: 22 microliters (μL) (20 ± l mg)\* of TIB200 Gel (ibuprofen 10% w/w) (Test Gel) or 22 μL (20 ± l mg)\* of matching placebo TIB200 Gel (placebo gel) or 22 μL (20 ± l mg)\* of Nurofen Maximum Strength Gel (ibuprofen 10% w/w) (reference gel).
|
Cohort 1: TIB200 Placebo Gel
n=8 Participants
Cohort 1: TIB200 matching placebo gel
Placebo: The placebo gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 2: DCF100 Gel 2%
n=8 Participants
Cohort 2: Diclofenac, DCF100 gel (2% w/w)
Diclofenac: Subjects were randomised to receive 22 uL (20 ± l mg) DCF100 Gel (diclofenac 2% w/w) / DCF100 Gel (diclofenac 4% w/w) / Matching Placebo DCF100 Gel / Voltarol® 12 Hour Emulgel® P 2.32% Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 2: DCF100 Gel 4%
n=8 Participants
Cohort 2: Diclofenac, DCF100 gel (4% w/w)
Diclofenac: Subjects were randomised to receive 22 uL (20 ± l mg) DCF100 Gel (diclofenac 2% w/w) / DCF100 Gel (diclofenac 4% w/w) / Matching Placebo DCF100 Gel / Voltarol® 12 Hour Emulgel® P 2.32% Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 1: TIB200 Gel 10%
n=8 Participants
Cohort 1: Ibuprofen, TIB200 gel (10%, w/w)
Ibuprofen: Single topical dose per 1.76 cm2 test site of: 22 microliters (μL) (20 ± l mg)\* of TIB200 Gel (ibuprofen 10% w/w) (Test Gel) or 22 μL (20 ± l mg)\* of matching placebo TIB200 Gel (placebo gel) or 22 μL (20 ± l mg)\* of Nurofen Maximum Strength Gel (ibuprofen 10% w/w) (reference gel).
|
Cohort 2: Voltaren Gel 2%
n=8 Participants
Cohort 2: Diclofenac, Voltaren Emulgel (2%)
Diclofenac: Subjects were randomised to receive 22 uL (20 ± l mg) DCF100 Gel (diclofenac 2% w/w) / DCF100 Gel (diclofenac 4% w/w) / Matching Placebo DCF100 Gel / Voltarol® 12 Hour Emulgel® P 2.32% Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 2: Voltarol Oral Tablet
n=8 Participants
Cohort 2: Diclofenac, Voltarol oral tablet (50 mg)
Diclofenac: Subjects were randomised to receive 22 uL (20 ± l mg) DCF100 Gel (diclofenac 2% w/w) / DCF100 Gel (diclofenac 4% w/w) / Matching Placebo DCF100 Gel / Voltarol® 12 Hour Emulgel® P 2.32% Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 2: DCF100 Placebo Gel
n=8 Participants
Cohort 2: DCF100 matching placebo gel
Placebo: The placebo gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 3: SPR300 Gel (15%:7%)
Cohort 3: Methyl-salicylate / Menthol, SPR300 gel (15%:7%, w/w; ratio of Methylsalicylate / Menthol)
Methyl-salicylate / Menthol: Subjects were randomised to receive 22 uL (20 ± l mg) SPR300 Gel / Matching Placebo SPR300 Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 3: SPR300 Placebo Gel
Cohort 3: SPR300 matching placebo gel
Placebo: The placebo gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Peak Plasma Concentration (Cmax)
|
5.15 ng/ml
Standard Deviation 8.1
|
29900 ng/ml
Standard Deviation 5490
|
0 ng/ml
Standard Deviation 0
|
0 ng/ml
Standard Deviation 0
|
0 ng/ml
Standard Deviation 0
|
11.5 ng/ml
Standard Deviation 14
|
772 ng/ml
Standard Deviation 468
|
0 ng/ml
Standard Deviation 0
|
0 ng/ml
Standard Deviation 0
|
—
|
—
|
SECONDARY outcome
Timeframe: 15 minutes before and 1, 2, 4 and 6 hours post administrationArea under the concentration vs. time curve from time zero to 6 hours (AUC0-6h) (up to 6 subjects per cohort only) laser Doppler imaging \[flux units\], up to 6 subjects per cohort)
Outcome measures
| Measure |
Cohort 1: Nurofen Gel 10%
n=8 Participants
Cohort 1: Ibuprofen, Nurofen Max Strength gel (10%, w/w)
Ibuprofen: Single topical dose per 1.76 cm2 test site of: 22 microliters (μL) (20 ± l mg)\* of TIB200 Gel (ibuprofen 10% w/w) (Test Gel) or 22 μL (20 ± l mg)\* of matching placebo TIB200 Gel (placebo gel) or 22 μL (20 ± l mg)\* of Nurofen Maximum Strength Gel (ibuprofen 10% w/w) (reference gel).
|
Cohort 1: Nurofen Tablets
n=8 Participants
Cohort 1: Ibuprofen, Nurofen oral tablets (2 x 400 mg)
Ibuprofen: Single topical dose per 1.76 cm2 test site of: 22 microliters (μL) (20 ± l mg)\* of TIB200 Gel (ibuprofen 10% w/w) (Test Gel) or 22 μL (20 ± l mg)\* of matching placebo TIB200 Gel (placebo gel) or 22 μL (20 ± l mg)\* of Nurofen Maximum Strength Gel (ibuprofen 10% w/w) (reference gel).
|
Cohort 1: TIB200 Placebo Gel
n=8 Participants
Cohort 1: TIB200 matching placebo gel
Placebo: The placebo gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 2: DCF100 Gel 2%
n=8 Participants
Cohort 2: Diclofenac, DCF100 gel (2% w/w)
Diclofenac: Subjects were randomised to receive 22 uL (20 ± l mg) DCF100 Gel (diclofenac 2% w/w) / DCF100 Gel (diclofenac 4% w/w) / Matching Placebo DCF100 Gel / Voltarol® 12 Hour Emulgel® P 2.32% Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 2: DCF100 Gel 4%
n=8 Participants
Cohort 2: Diclofenac, DCF100 gel (4% w/w)
Diclofenac: Subjects were randomised to receive 22 uL (20 ± l mg) DCF100 Gel (diclofenac 2% w/w) / DCF100 Gel (diclofenac 4% w/w) / Matching Placebo DCF100 Gel / Voltarol® 12 Hour Emulgel® P 2.32% Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 1: TIB200 Gel 10%
n=8 Participants
Cohort 1: Ibuprofen, TIB200 gel (10%, w/w)
Ibuprofen: Single topical dose per 1.76 cm2 test site of: 22 microliters (μL) (20 ± l mg)\* of TIB200 Gel (ibuprofen 10% w/w) (Test Gel) or 22 μL (20 ± l mg)\* of matching placebo TIB200 Gel (placebo gel) or 22 μL (20 ± l mg)\* of Nurofen Maximum Strength Gel (ibuprofen 10% w/w) (reference gel).
|
Cohort 2: Voltaren Gel 2%
n=8 Participants
Cohort 2: Diclofenac, Voltaren Emulgel (2%)
Diclofenac: Subjects were randomised to receive 22 uL (20 ± l mg) DCF100 Gel (diclofenac 2% w/w) / DCF100 Gel (diclofenac 4% w/w) / Matching Placebo DCF100 Gel / Voltarol® 12 Hour Emulgel® P 2.32% Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 2: Voltarol Oral Tablet
n=8 Participants
Cohort 2: Diclofenac, Voltarol oral tablet (50 mg)
Diclofenac: Subjects were randomised to receive 22 uL (20 ± l mg) DCF100 Gel (diclofenac 2% w/w) / DCF100 Gel (diclofenac 4% w/w) / Matching Placebo DCF100 Gel / Voltarol® 12 Hour Emulgel® P 2.32% Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 2: DCF100 Placebo Gel
n=8 Participants
Cohort 2: DCF100 matching placebo gel
Placebo: The placebo gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 3: SPR300 Gel (15%:7%)
Cohort 3: Methyl-salicylate / Menthol, SPR300 gel (15%:7%, w/w; ratio of Methylsalicylate / Menthol)
Methyl-salicylate / Menthol: Subjects were randomised to receive 22 uL (20 ± l mg) SPR300 Gel / Matching Placebo SPR300 Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 3: SPR300 Placebo Gel
Cohort 3: SPR300 matching placebo gel
Placebo: The placebo gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve
|
19.9 h*ng/ml
Standard Deviation 33.7
|
90000 h*ng/ml
Standard Deviation 15400
|
0 h*ng/ml
Standard Deviation 0
|
0 h*ng/ml
Standard Deviation 0
|
0 h*ng/ml
Standard Deviation 0
|
47.7 h*ng/ml
Standard Deviation 64.3
|
1030 h*ng/ml
Standard Deviation 463
|
0 h*ng/ml
Standard Deviation 0
|
0 h*ng/ml
Standard Deviation 0
|
—
|
—
|
SECONDARY outcome
Timeframe: Estimated study duration for each subject will be approximately 6 weeksLaboratory assessments - standard clinical trial assessments for clinical chemistry and haematology Listing of individual laboratory measurements by subjects and evaluation of each laboratory parameter
Outcome measures
| Measure |
Cohort 1: Nurofen Gel 10%
n=20 Participants
Cohort 1: Ibuprofen, Nurofen Max Strength gel (10%, w/w)
Ibuprofen: Single topical dose per 1.76 cm2 test site of: 22 microliters (μL) (20 ± l mg)\* of TIB200 Gel (ibuprofen 10% w/w) (Test Gel) or 22 μL (20 ± l mg)\* of matching placebo TIB200 Gel (placebo gel) or 22 μL (20 ± l mg)\* of Nurofen Maximum Strength Gel (ibuprofen 10% w/w) (reference gel).
|
Cohort 1: Nurofen Tablets
n=20 Participants
Cohort 1: Ibuprofen, Nurofen oral tablets (2 x 400 mg)
Ibuprofen: Single topical dose per 1.76 cm2 test site of: 22 microliters (μL) (20 ± l mg)\* of TIB200 Gel (ibuprofen 10% w/w) (Test Gel) or 22 μL (20 ± l mg)\* of matching placebo TIB200 Gel (placebo gel) or 22 μL (20 ± l mg)\* of Nurofen Maximum Strength Gel (ibuprofen 10% w/w) (reference gel).
|
Cohort 1: TIB200 Placebo Gel
n=20 Participants
Cohort 1: TIB200 matching placebo gel
Placebo: The placebo gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 2: DCF100 Gel 2%
n=20 Participants
Cohort 2: Diclofenac, DCF100 gel (2% w/w)
Diclofenac: Subjects were randomised to receive 22 uL (20 ± l mg) DCF100 Gel (diclofenac 2% w/w) / DCF100 Gel (diclofenac 4% w/w) / Matching Placebo DCF100 Gel / Voltarol® 12 Hour Emulgel® P 2.32% Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 2: DCF100 Gel 4%
n=20 Participants
Cohort 2: Diclofenac, DCF100 gel (4% w/w)
Diclofenac: Subjects were randomised to receive 22 uL (20 ± l mg) DCF100 Gel (diclofenac 2% w/w) / DCF100 Gel (diclofenac 4% w/w) / Matching Placebo DCF100 Gel / Voltarol® 12 Hour Emulgel® P 2.32% Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 1: TIB200 Gel 10%
n=20 Participants
Cohort 1: Ibuprofen, TIB200 gel (10%, w/w)
Ibuprofen: Single topical dose per 1.76 cm2 test site of: 22 microliters (μL) (20 ± l mg)\* of TIB200 Gel (ibuprofen 10% w/w) (Test Gel) or 22 μL (20 ± l mg)\* of matching placebo TIB200 Gel (placebo gel) or 22 μL (20 ± l mg)\* of Nurofen Maximum Strength Gel (ibuprofen 10% w/w) (reference gel).
|
Cohort 2: Voltaren Gel 2%
n=20 Participants
Cohort 2: Diclofenac, Voltaren Emulgel (2%)
Diclofenac: Subjects were randomised to receive 22 uL (20 ± l mg) DCF100 Gel (diclofenac 2% w/w) / DCF100 Gel (diclofenac 4% w/w) / Matching Placebo DCF100 Gel / Voltarol® 12 Hour Emulgel® P 2.32% Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 2: Voltarol Oral Tablet
n=20 Participants
Cohort 2: Diclofenac, Voltarol oral tablet (50 mg)
Diclofenac: Subjects were randomised to receive 22 uL (20 ± l mg) DCF100 Gel (diclofenac 2% w/w) / DCF100 Gel (diclofenac 4% w/w) / Matching Placebo DCF100 Gel / Voltarol® 12 Hour Emulgel® P 2.32% Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 2: DCF100 Placebo Gel
n=20 Participants
Cohort 2: DCF100 matching placebo gel
Placebo: The placebo gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 3: SPR300 Gel (15%:7%)
n=20 Participants
Cohort 3: Methyl-salicylate / Menthol, SPR300 gel (15%:7%, w/w; ratio of Methylsalicylate / Menthol)
Methyl-salicylate / Menthol: Subjects were randomised to receive 22 uL (20 ± l mg) SPR300 Gel / Matching Placebo SPR300 Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 3: SPR300 Placebo Gel
n=20 Participants
Cohort 3: SPR300 matching placebo gel
Placebo: The placebo gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Recorded Abnormal Clinical Assessments
|
0 Assessments
|
0 Assessments
|
0 Assessments
|
0 Assessments
|
0 Assessments
|
0 Assessments
|
0 Assessments
|
0 Assessments
|
0 Assessments
|
0 Assessments
|
0 Assessments
|
SECONDARY outcome
Timeframe: Estimated study duration for each subject will be approximately 6 weeksPhysical examinations - including assessments of the application site. examination.
Outcome measures
| Measure |
Cohort 1: Nurofen Gel 10%
n=20 Participants
Cohort 1: Ibuprofen, Nurofen Max Strength gel (10%, w/w)
Ibuprofen: Single topical dose per 1.76 cm2 test site of: 22 microliters (μL) (20 ± l mg)\* of TIB200 Gel (ibuprofen 10% w/w) (Test Gel) or 22 μL (20 ± l mg)\* of matching placebo TIB200 Gel (placebo gel) or 22 μL (20 ± l mg)\* of Nurofen Maximum Strength Gel (ibuprofen 10% w/w) (reference gel).
|
Cohort 1: Nurofen Tablets
n=20 Participants
Cohort 1: Ibuprofen, Nurofen oral tablets (2 x 400 mg)
Ibuprofen: Single topical dose per 1.76 cm2 test site of: 22 microliters (μL) (20 ± l mg)\* of TIB200 Gel (ibuprofen 10% w/w) (Test Gel) or 22 μL (20 ± l mg)\* of matching placebo TIB200 Gel (placebo gel) or 22 μL (20 ± l mg)\* of Nurofen Maximum Strength Gel (ibuprofen 10% w/w) (reference gel).
|
Cohort 1: TIB200 Placebo Gel
n=20 Participants
Cohort 1: TIB200 matching placebo gel
Placebo: The placebo gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 2: DCF100 Gel 2%
n=20 Participants
Cohort 2: Diclofenac, DCF100 gel (2% w/w)
Diclofenac: Subjects were randomised to receive 22 uL (20 ± l mg) DCF100 Gel (diclofenac 2% w/w) / DCF100 Gel (diclofenac 4% w/w) / Matching Placebo DCF100 Gel / Voltarol® 12 Hour Emulgel® P 2.32% Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 2: DCF100 Gel 4%
n=20 Participants
Cohort 2: Diclofenac, DCF100 gel (4% w/w)
Diclofenac: Subjects were randomised to receive 22 uL (20 ± l mg) DCF100 Gel (diclofenac 2% w/w) / DCF100 Gel (diclofenac 4% w/w) / Matching Placebo DCF100 Gel / Voltarol® 12 Hour Emulgel® P 2.32% Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 1: TIB200 Gel 10%
n=20 Participants
Cohort 1: Ibuprofen, TIB200 gel (10%, w/w)
Ibuprofen: Single topical dose per 1.76 cm2 test site of: 22 microliters (μL) (20 ± l mg)\* of TIB200 Gel (ibuprofen 10% w/w) (Test Gel) or 22 μL (20 ± l mg)\* of matching placebo TIB200 Gel (placebo gel) or 22 μL (20 ± l mg)\* of Nurofen Maximum Strength Gel (ibuprofen 10% w/w) (reference gel).
|
Cohort 2: Voltaren Gel 2%
n=20 Participants
Cohort 2: Diclofenac, Voltaren Emulgel (2%)
Diclofenac: Subjects were randomised to receive 22 uL (20 ± l mg) DCF100 Gel (diclofenac 2% w/w) / DCF100 Gel (diclofenac 4% w/w) / Matching Placebo DCF100 Gel / Voltarol® 12 Hour Emulgel® P 2.32% Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 2: Voltarol Oral Tablet
n=20 Participants
Cohort 2: Diclofenac, Voltarol oral tablet (50 mg)
Diclofenac: Subjects were randomised to receive 22 uL (20 ± l mg) DCF100 Gel (diclofenac 2% w/w) / DCF100 Gel (diclofenac 4% w/w) / Matching Placebo DCF100 Gel / Voltarol® 12 Hour Emulgel® P 2.32% Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 2: DCF100 Placebo Gel
n=20 Participants
Cohort 2: DCF100 matching placebo gel
Placebo: The placebo gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 3: SPR300 Gel (15%:7%)
n=20 Participants
Cohort 3: Methyl-salicylate / Menthol, SPR300 gel (15%:7%, w/w; ratio of Methylsalicylate / Menthol)
Methyl-salicylate / Menthol: Subjects were randomised to receive 22 uL (20 ± l mg) SPR300 Gel / Matching Placebo SPR300 Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 3: SPR300 Placebo Gel
n=20 Participants
Cohort 3: SPR300 matching placebo gel
Placebo: The placebo gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Physical Exams to Ensure Safety and Well Being of the Subjects
|
0 Abnormalities
|
0 Abnormalities
|
0 Abnormalities
|
0 Abnormalities
|
0 Abnormalities
|
0 Abnormalities
|
0 Abnormalities
|
0 Abnormalities
|
0 Abnormalities
|
0 Abnormalities
|
0 Abnormalities
|
SECONDARY outcome
Timeframe: Estimated study duration for each subject will be approximately 6 weeksLocal and systemic Adverse Events (AEs).
Outcome measures
| Measure |
Cohort 1: Nurofen Gel 10%
n=20 Participants
Cohort 1: Ibuprofen, Nurofen Max Strength gel (10%, w/w)
Ibuprofen: Single topical dose per 1.76 cm2 test site of: 22 microliters (μL) (20 ± l mg)\* of TIB200 Gel (ibuprofen 10% w/w) (Test Gel) or 22 μL (20 ± l mg)\* of matching placebo TIB200 Gel (placebo gel) or 22 μL (20 ± l mg)\* of Nurofen Maximum Strength Gel (ibuprofen 10% w/w) (reference gel).
|
Cohort 1: Nurofen Tablets
n=20 Participants
Cohort 1: Ibuprofen, Nurofen oral tablets (2 x 400 mg)
Ibuprofen: Single topical dose per 1.76 cm2 test site of: 22 microliters (μL) (20 ± l mg)\* of TIB200 Gel (ibuprofen 10% w/w) (Test Gel) or 22 μL (20 ± l mg)\* of matching placebo TIB200 Gel (placebo gel) or 22 μL (20 ± l mg)\* of Nurofen Maximum Strength Gel (ibuprofen 10% w/w) (reference gel).
|
Cohort 1: TIB200 Placebo Gel
n=20 Participants
Cohort 1: TIB200 matching placebo gel
Placebo: The placebo gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 2: DCF100 Gel 2%
n=20 Participants
Cohort 2: Diclofenac, DCF100 gel (2% w/w)
Diclofenac: Subjects were randomised to receive 22 uL (20 ± l mg) DCF100 Gel (diclofenac 2% w/w) / DCF100 Gel (diclofenac 4% w/w) / Matching Placebo DCF100 Gel / Voltarol® 12 Hour Emulgel® P 2.32% Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 2: DCF100 Gel 4%
n=20 Participants
Cohort 2: Diclofenac, DCF100 gel (4% w/w)
Diclofenac: Subjects were randomised to receive 22 uL (20 ± l mg) DCF100 Gel (diclofenac 2% w/w) / DCF100 Gel (diclofenac 4% w/w) / Matching Placebo DCF100 Gel / Voltarol® 12 Hour Emulgel® P 2.32% Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 1: TIB200 Gel 10%
n=20 Participants
Cohort 1: Ibuprofen, TIB200 gel (10%, w/w)
Ibuprofen: Single topical dose per 1.76 cm2 test site of: 22 microliters (μL) (20 ± l mg)\* of TIB200 Gel (ibuprofen 10% w/w) (Test Gel) or 22 μL (20 ± l mg)\* of matching placebo TIB200 Gel (placebo gel) or 22 μL (20 ± l mg)\* of Nurofen Maximum Strength Gel (ibuprofen 10% w/w) (reference gel).
|
Cohort 2: Voltaren Gel 2%
n=20 Participants
Cohort 2: Diclofenac, Voltaren Emulgel (2%)
Diclofenac: Subjects were randomised to receive 22 uL (20 ± l mg) DCF100 Gel (diclofenac 2% w/w) / DCF100 Gel (diclofenac 4% w/w) / Matching Placebo DCF100 Gel / Voltarol® 12 Hour Emulgel® P 2.32% Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 2: Voltarol Oral Tablet
n=20 Participants
Cohort 2: Diclofenac, Voltarol oral tablet (50 mg)
Diclofenac: Subjects were randomised to receive 22 uL (20 ± l mg) DCF100 Gel (diclofenac 2% w/w) / DCF100 Gel (diclofenac 4% w/w) / Matching Placebo DCF100 Gel / Voltarol® 12 Hour Emulgel® P 2.32% Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 2: DCF100 Placebo Gel
n=20 Participants
Cohort 2: DCF100 matching placebo gel
Placebo: The placebo gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 3: SPR300 Gel (15%:7%)
n=20 Participants
Cohort 3: Methyl-salicylate / Menthol, SPR300 gel (15%:7%, w/w; ratio of Methylsalicylate / Menthol)
Methyl-salicylate / Menthol: Subjects were randomised to receive 22 uL (20 ± l mg) SPR300 Gel / Matching Placebo SPR300 Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 3: SPR300 Placebo Gel
n=20 Participants
Cohort 3: SPR300 matching placebo gel
Placebo: The placebo gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Adverse Events (AEs)
|
5 Events
|
1 Events
|
1 Events
|
1 Events
|
1 Events
|
5 Events
|
0 Events
|
2 Events
|
0 Events
|
3 Events
|
1 Events
|
SECONDARY outcome
Timeframe: Estimated study duration for each subject will be approximately 6 weeksTo determine Vital Signs and Electrocardiograms (ECGs) that were abnormal to ensure safety and well being of the subjects
Outcome measures
| Measure |
Cohort 1: Nurofen Gel 10%
n=20 Participants
Cohort 1: Ibuprofen, Nurofen Max Strength gel (10%, w/w)
Ibuprofen: Single topical dose per 1.76 cm2 test site of: 22 microliters (μL) (20 ± l mg)\* of TIB200 Gel (ibuprofen 10% w/w) (Test Gel) or 22 μL (20 ± l mg)\* of matching placebo TIB200 Gel (placebo gel) or 22 μL (20 ± l mg)\* of Nurofen Maximum Strength Gel (ibuprofen 10% w/w) (reference gel).
|
Cohort 1: Nurofen Tablets
n=20 Participants
Cohort 1: Ibuprofen, Nurofen oral tablets (2 x 400 mg)
Ibuprofen: Single topical dose per 1.76 cm2 test site of: 22 microliters (μL) (20 ± l mg)\* of TIB200 Gel (ibuprofen 10% w/w) (Test Gel) or 22 μL (20 ± l mg)\* of matching placebo TIB200 Gel (placebo gel) or 22 μL (20 ± l mg)\* of Nurofen Maximum Strength Gel (ibuprofen 10% w/w) (reference gel).
|
Cohort 1: TIB200 Placebo Gel
n=20 Participants
Cohort 1: TIB200 matching placebo gel
Placebo: The placebo gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 2: DCF100 Gel 2%
n=20 Participants
Cohort 2: Diclofenac, DCF100 gel (2% w/w)
Diclofenac: Subjects were randomised to receive 22 uL (20 ± l mg) DCF100 Gel (diclofenac 2% w/w) / DCF100 Gel (diclofenac 4% w/w) / Matching Placebo DCF100 Gel / Voltarol® 12 Hour Emulgel® P 2.32% Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 2: DCF100 Gel 4%
n=20 Participants
Cohort 2: Diclofenac, DCF100 gel (4% w/w)
Diclofenac: Subjects were randomised to receive 22 uL (20 ± l mg) DCF100 Gel (diclofenac 2% w/w) / DCF100 Gel (diclofenac 4% w/w) / Matching Placebo DCF100 Gel / Voltarol® 12 Hour Emulgel® P 2.32% Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 1: TIB200 Gel 10%
n=20 Participants
Cohort 1: Ibuprofen, TIB200 gel (10%, w/w)
Ibuprofen: Single topical dose per 1.76 cm2 test site of: 22 microliters (μL) (20 ± l mg)\* of TIB200 Gel (ibuprofen 10% w/w) (Test Gel) or 22 μL (20 ± l mg)\* of matching placebo TIB200 Gel (placebo gel) or 22 μL (20 ± l mg)\* of Nurofen Maximum Strength Gel (ibuprofen 10% w/w) (reference gel).
|
Cohort 2: Voltaren Gel 2%
n=20 Participants
Cohort 2: Diclofenac, Voltaren Emulgel (2%)
Diclofenac: Subjects were randomised to receive 22 uL (20 ± l mg) DCF100 Gel (diclofenac 2% w/w) / DCF100 Gel (diclofenac 4% w/w) / Matching Placebo DCF100 Gel / Voltarol® 12 Hour Emulgel® P 2.32% Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 2: Voltarol Oral Tablet
n=20 Participants
Cohort 2: Diclofenac, Voltarol oral tablet (50 mg)
Diclofenac: Subjects were randomised to receive 22 uL (20 ± l mg) DCF100 Gel (diclofenac 2% w/w) / DCF100 Gel (diclofenac 4% w/w) / Matching Placebo DCF100 Gel / Voltarol® 12 Hour Emulgel® P 2.32% Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 2: DCF100 Placebo Gel
n=20 Participants
Cohort 2: DCF100 matching placebo gel
Placebo: The placebo gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 3: SPR300 Gel (15%:7%)
n=20 Participants
Cohort 3: Methyl-salicylate / Menthol, SPR300 gel (15%:7%, w/w; ratio of Methylsalicylate / Menthol)
Methyl-salicylate / Menthol: Subjects were randomised to receive 22 uL (20 ± l mg) SPR300 Gel / Matching Placebo SPR300 Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 3: SPR300 Placebo Gel
n=20 Participants
Cohort 3: SPR300 matching placebo gel
Placebo: The placebo gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
To Determine Vital Signs and Electrocardiograms (ECGs) That Were Abnormal to Ensure Safety and Well Being of the Subjects
|
0 Abnormal readings
|
0 Abnormal readings
|
0 Abnormal readings
|
0 Abnormal readings
|
0 Abnormal readings
|
0 Abnormal readings
|
0 Abnormal readings
|
0 Abnormal readings
|
0 Abnormal readings
|
0 Abnormal readings
|
0 Abnormal readings
|
Adverse Events
Cohort 1: TIB200 Gel 10%
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 1: Nurofen Gel 10%
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 1: Nurofen Tablets
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 1: TIB200 Placebo Gel
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 2: DCF100 Gel 2%
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 2: DCF100 Gel 4%
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 2: Voltaren Gel 2%
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 2: Voltarol Oral Tablet
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 2: DCF100 Placebo Gel
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 3: SPR300 Gel (15%:7%)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 3: SPR300 Placebo Gel
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1: TIB200 Gel 10%
n=20 participants at risk
Cohort 1: Ibuprofen, TIB200 gel (10%, w/w)
Ibuprofen: Single topical dose per 1.76 cm2 test site of: 22 microliters (μL) (20 ± l mg)\* of TIB200 Gel (ibuprofen 10% w/w) (Test Gel) or 22 μL (20 ± l mg)\* of matching placebo TIB200 Gel (placebo gel) or 22 μL (20 ± l mg)\* of Nurofen Maximum Strength Gel (ibuprofen 10% w/w) (reference gel).
|
Cohort 1: Nurofen Gel 10%
n=20 participants at risk
Cohort 1: Ibuprofen, Nurofen Max Strength gel (10%, w/w)
Ibuprofen: Single topical dose per 1.76 cm2 test site of: 22 microliters (μL) (20 ± l mg)\* of TIB200 Gel (ibuprofen 10% w/w) (Test Gel) or 22 μL (20 ± l mg)\* of matching placebo TIB200 Gel (placebo gel) or 22 μL (20 ± l mg)\* of Nurofen Maximum Strength Gel (ibuprofen 10% w/w) (reference gel).
|
Cohort 1: Nurofen Tablets
n=20 participants at risk
Cohort 1: Ibuprofen, Nurofen oral tablets (2 x 400 mg)
Ibuprofen: Single topical dose per 1.76 cm2 test site of: 22 microliters (μL) (20 ± l mg)\* of TIB200 Gel (ibuprofen 10% w/w) (Test Gel) or 22 μL (20 ± l mg)\* of matching placebo TIB200 Gel (placebo gel) or 22 μL (20 ± l mg)\* of Nurofen Maximum Strength Gel (ibuprofen 10% w/w) (reference gel).
|
Cohort 1: TIB200 Placebo Gel
n=20 participants at risk
Cohort 1: TIB200 matching placebo gel
Placebo: The placebo gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 2: DCF100 Gel 2%
n=20 participants at risk
Cohort 2: Diclofenac, DCF100 gel (2% w/w)
Diclofenac: Subjects were randomised to receive 22 uL (20 ± l mg) DCF100 Gel (diclofenac 2% w/w) / DCF100 Gel (diclofenac 4% w/w) / Matching Placebo DCF100 Gel / Voltarol® 12 Hour Emulgel® P 2.32% Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 2: DCF100 Gel 4%
n=20 participants at risk
Cohort 2: Diclofenac, DCF100 gel (4% w/w)
Diclofenac: Subjects were randomised to receive 22 uL (20 ± l mg) DCF100 Gel (diclofenac 2% w/w) / DCF100 Gel (diclofenac 4% w/w) / Matching Placebo DCF100 Gel / Voltarol® 12 Hour Emulgel® P 2.32% Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 2: Voltaren Gel 2%
n=20 participants at risk
Cohort 2: Diclofenac, Voltaren Emulgel (2%)
Diclofenac: Subjects were randomised to receive 22 uL (20 ± l mg) DCF100 Gel (diclofenac 2% w/w) / DCF100 Gel (diclofenac 4% w/w) / Matching Placebo DCF100 Gel / Voltarol® 12 Hour Emulgel® P 2.32% Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 2: Voltarol Oral Tablet
n=20 participants at risk
Cohort 2: Diclofenac, Voltarol oral tablet (50 mg)
Diclofenac: Subjects were randomised to receive 22 uL (20 ± l mg) DCF100 Gel (diclofenac 2% w/w) / DCF100 Gel (diclofenac 4% w/w) / Matching Placebo DCF100 Gel / Voltarol® 12 Hour Emulgel® P 2.32% Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 2: DCF100 Placebo Gel
n=20 participants at risk
Cohort 2: DCF100 matching placebo gel
Placebo: The placebo gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 3: SPR300 Gel (15%:7%)
n=20 participants at risk
Cohort 3: Methyl-salicylate / Menthol, SPR300 gel (15%:7%, w/w; ratio of Methylsalicylate / Menthol)
Methyl-salicylate / Menthol: Subjects were randomised to receive 22 uL (20 ± l mg) SPR300 Gel / Matching Placebo SPR300 Gel. The gels were administered topically on two test sites on the lower back of the subject, each 1.76cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
Cohort 3: SPR300 Placebo Gel
n=20 participants at risk
Cohort 3: SPR300 matching placebo gel
Placebo: The placebo gels were administered topically on two test sites on the lower back of the subject, each 1.76 cm2 in size. The two test sites were UVB irradiated on the previous day, between 22 and 26 hours (24 ± 2 hours) before dosing.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
5.0%
1/20 • Number of events 1 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
|
Skin and subcutaneous tissue disorders
Itching
|
5.0%
1/20 • Number of events 1 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
20.0%
4/20 • Number of events 4 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
5.0%
1/20 • Number of events 1 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
|
General disorders
Pain Burning
|
5.0%
1/20 • Number of events 1 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
5.0%
1/20 • Number of events 1 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
10.0%
2/20 • Number of events 2 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
|
Gastrointestinal disorders
toothache
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
5.0%
1/20 • Number of events 1 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
|
Gastrointestinal disorders
headache
|
5.0%
1/20 • Number of events 1 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
|
Vascular disorders
Hot Flush
|
5.0%
1/20 • Number of events 1 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20 • Number of events 1 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
|
Renal and urinary disorders
Frequency of Micturation Increased
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
5.0%
1/20 • Number of events 1 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
|
Gastrointestinal disorders
Soft Stools
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
5.0%
1/20 • Number of events 1 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
|
Infections and infestations
Commom Cold
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
5.0%
1/20 • Number of events 1 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
|
Skin and subcutaneous tissue disorders
Erythematous Rash
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
5.0%
1/20 • Number of events 1 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
|
Respiratory, thoracic and mediastinal disorders
Runny Nose
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
0.00%
0/20 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
5.0%
1/20 • Number of events 1 • 3 months
All AE's were reported as this was a phase 1 study The threshold for reporting was therefore greater than 0%
|
Additional Information
Director of Clinical Development
Futura Medical Developments Limited
Phone: 01483685683
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place