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Assess the Efficacy and Safety in Volunteers of DCF100, TIB200 and SPR300 vs. Placebo and Control(s) in a UV Pain Model

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ClinicalTrials.gov Identifier: NCT02666846
Recruitment Status : Completed
First Posted : January 28, 2016
Results First Posted : September 29, 2020
Last Update Posted : January 27, 2021
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
Futura Medical Developments Ltd.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Pain
Interventions Drug: Ibuprofen
Drug: Diclofenac
Drug: Methyl-salicylate / Menthol
Drug: Placebo
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cohort 1 (Dosed on Days 1, 2 and 3) Cohort 2 (Dosed on Days 1,2,3 and 4) Cohort 3 (Dosed on Days 1 and 2)
Hide Arm/Group Description

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).

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.

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.

Period Title: Overall Study
Started 20 20 20
Completed 20 20 20
Not Completed 0 0 0
Arm/Group Title Cohort 1 Cohort 2: Cohort 3 Total
Hide Arm/Group Description

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:

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:

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 of all reporting groups
Overall Number of Baseline Participants 20 20 20 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 20 participants 60 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
20
 100.0%
20
 100.0%
20
 100.0%
60
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 20 participants 60 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
20
 100.0%
20
 100.0%
20
 100.0%
60
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 20 participants 20 participants 20 participants 60 participants
20 20 20 20
1.Primary Outcome
Title Heat Pain Tolerance Test (HPTT) Measured the Point at Which the Heat Became Painful - Degrees Centigrade -
Hide Description 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.
Time Frame 15 minutes before to 6 hours post administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort 1: TIB200 Gel 10% Cohort 1: Nurofen Gel 10% Cohort 1: Nurofen Tablets Cohort 1: TIB200 Placebo Gel Cohort 2: DCF100 Gel 2% Cohort 2: DCF100 Gel 4% Cohort 2: Voltaren Gel 2% Cohort 2: Voltarol Oral Tablet Cohort 2: DCF100 Placebo Gel Cohort 3: SPR300 Gel (15%:7%) Cohort 3: SPR300 Placebo Gel
Hide Arm/Group Description:

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: 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: 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 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: 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: 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: 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: 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 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: 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 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.

Overall Number of Participants Analyzed 20 20 20 20 20 20 20 20 20 20 20
Mean (Standard Deviation)
Unit of Measure: Degrees Centigrade
0.3635  (1.0277) 0.7358  (1.0277) 0.0887  (0.9024) -0.1983  (0.4616) 0.6679  (1.0657) 0.8722  (1.0430) 0.7978  (0.9780) 0.6835  (0.7344) 0.1688  (0.7231) 0.3934  (1.2384) -0.0123  (1.0103)
2.Primary Outcome
Title Intensity of the UVB-induced Erythema (Determined by Assessment of Skin Blood Flow by Laser Doppler Imaging [Flux Units])
Hide Description Intensity 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
Time Frame 15 minutes before to 6 hours post administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort 1: TIB200 Gel 10% Cohort 1: Nurofen Gel 10% Cohort 1: Nurofen Tablets Cohort 1: TIB200 Placebo Gel Cohort 2: DCF100 Gel 2% Cohort 2: DCF100 Gel 4% Cohort 2: Voltaren Gel 2% Cohort 2: Voltarol Oral Tablet Cohort 2: DCF100 Placebo Gel Cohort 3: SPR300 Gel (15%:7%) Cohort 3: SPR300 Placebo Gel
Hide Arm/Group Description:

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: 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: 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 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: 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: 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: 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: 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 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: 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 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.

Overall Number of Participants Analyzed 8 8 8 8 8 8 8 8 8 8 8
Least Squares Mean (Standard Deviation)
Unit of Measure: Laser doppler imaging (Flux Units)
-313.3879  (105.7042) -171.5589  (96.6485) -262.0693  (88.5449) -95.3974  (81.4103) -228.3016  (183.2260) -278.1918  (103.7333) -198.1408  (133.2886) -198.1408  (211.2754) -45.376  (104.4476) 12.2265  (111.1065) 67.3931  (91.092)
3.Secondary Outcome
Title Peak Plasma Concentration (Cmax)
Hide Description Maximum 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)
Time Frame 15 minutes before and 1, 2, 4 and 6 hours post administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort 1: TIB200 Gel 10% Cohort 1: Nurofen Gel 10% Cohort 1: Nurofen Tablets Cohort 2: DCF100 Gel 2% Cohort 2: DCF100 Gel 4% Cohort 2: Voltaren Gel 2% Cohort 2: Voltarol Oral Tablet Cohort 3: SPR300 Gel (15%:7%) Cohort 3: SPR300 Placebo Gel
Hide Arm/Group Description:

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: 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: 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 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: 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: 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: 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 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 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.

Overall Number of Participants Analyzed 8 8 8 8 8 8 8 8 8
Mean (Standard Deviation)
Unit of Measure: ng/ml
11.5  (14) 5.15  (8.1) 29900  (5490) 0  (0) 0  (0) 0  (0) 772  (468) 0  (0) 0  (0)
4.Secondary Outcome
Title Area Under the Plasma Concentration Versus Time Curve
Hide Description Area 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)
Time Frame 15 minutes before and 1, 2, 4 and 6 hours post administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort 1: TIB200 Gel 10% Cohort 1: Nurofen Gel 10% Cohort 1: Nurofen Tablets Cohort 2: DCF100 Gel 2% Cohort 2: DCF100 Gel 4% Cohort 2: Voltaren Gel 2% Cohort 2: Voltarol Oral Tablet Cohort 3: SPR300 Gel (15%:7%) Cohort 3: SPR300 Placebo Gel
Hide Arm/Group Description:

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: 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: 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 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: 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: 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: 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 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 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.

Overall Number of Participants Analyzed 8 8 8 8 8 8 8 8 8
Mean (Standard Deviation)
Unit of Measure: h*ng/ml
47.7  (64.3) 19.9  (33.7) 90000  (15400) 0  (0) 0  (0) 0  (0) 1030  (463) 0  (0) 0  (0)
5.Secondary Outcome
Title Number of Recorded Abnormal Clinical Assessments
Hide Description

Laboratory assessments - standard clinical trial assessments for clinical chemistry and haematology

Listing of individual laboratory measurements by subjects and evaluation of each laboratory parameter

Time Frame Estimated study duration for each subject will be approximately 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort 1: TIB200 Gel 10% Cohort 1: Nurofen Gel 10% Cohort 1: Nurofen Tablets Cohort 1: TIB200 Placebo Gel Cohort 2: DCF100 Gel 2% Cohort 2: DCF100 Gel 4% Cohort 2: Voltaren Gel 2% Cohort 2: Voltarol Oral Tablet Cohort 2: DCF100 Placebo Gel Cohort 3: SPR300 Gel (15%:7%) Cohort 3: SPR300 Placebo Gel
Hide Arm/Group Description:

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: 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: 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 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: 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: 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: 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: 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 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: 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 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.

Overall Number of Participants Analyzed 20 20 20 20 20 20 20 20 20 20 20
Measure Type: Number
Unit of Measure: Assessments
0 0 0 0 0 0 0 0 0 0 0
6.Secondary Outcome
Title Physical Exams to Ensure Safety and Well Being of the Subjects
Hide Description Physical examinations - including assessments of the application site. examination.
Time Frame Estimated study duration for each subject will be approximately 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort 1: TIB200 Gel 10% Cohort 1: Nurofen Gel 10% Cohort 1: Nurofen Tablets Cohort 1: TIB200 Placebo Gel Cohort 2: DCF100 Gel 2% Cohort 2: DCF100 Gel 4% Cohort 2: Voltaren Gel 2% Cohort 2: Voltarol Oral Tablet Cohort 2: DCF100 Placebo Gel Cohort 3: SPR300 Gel (15%:7%) Cohort 3: SPR300 Placebo Gel
Hide Arm/Group Description:

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: 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: 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 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: 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: 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: 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: 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 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: 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 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.

Overall Number of Participants Analyzed 20 20 20 20 20 20 20 20 20 20 20
Measure Type: Number
Unit of Measure: Abnormalities
0 0 0 0 0 0 0 0 0 0 0
7.Secondary Outcome
Title Adverse Events (AEs)
Hide Description Local and systemic Adverse Events (AEs).
Time Frame Estimated study duration for each subject will be approximately 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort 1: TIB200 Gel 10% Cohort 1: Nurofen Gel 10% Cohort 1: Nurofen Tablets Cohort 1: TIB200 Placebo Gel Cohort 2: DCF100 Gel 2% Cohort 2: DCF100 Gel 4% Cohort 2: Voltaren Gel 2% Cohort 2: Voltarol Oral Tablet Cohort 2: DCF100 Placebo Gel Cohort 3: SPR300 Gel (15%:7%) Cohort 3: SPR300 Placebo Gel
Hide Arm/Group Description:

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: 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: 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 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: 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: 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: 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: 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 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: 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 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.

Overall Number of Participants Analyzed 20 20 20 20 20 20 20 20 20 20 20
Measure Type: Number
Unit of Measure: Events
5 5 1 1 1 1 0 2 0 3 1
8.Secondary Outcome
Title To Determine Vital Signs and Electrocardiograms (ECGs) That Were Abnormal to Ensure Safety and Well Being of the Subjects
Hide Description To determine Vital Signs and Electrocardiograms (ECGs) that were abnormal to ensure safety and well being of the subjects
Time Frame Estimated study duration for each subject will be approximately 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort 1: TIB200 Gel 10% Cohort 1: Nurofen Gel 10% Cohort 1: Nurofen Tablets Cohort 1: TIB200 Placebo Gel Cohort 2: DCF100 Gel 2% Cohort 2: DCF100 Gel 4% Cohort 2: Voltaren Gel 2% Cohort 2: Voltarol Oral Tablet Cohort 2: DCF100 Placebo Gel Cohort 3: SPR300 Gel (15%:7%) Cohort 3: SPR300 Placebo Gel
Hide Arm/Group Description:

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: 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: 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 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: 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: 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: 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: 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 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: 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 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.

Overall Number of Participants Analyzed 20 20 20 20 20 20 20 20 20 20 20
Measure Type: Number
Unit of Measure: Abnormal readings
0 0 0 0 0 0 0 0 0 0 0
Time Frame 3 months
Adverse Event Reporting Description

All AE's were reported as this was a phase 1 study

The threshold for reporting was therefore greater than 0%

 
Arm/Group Title Cohort 1: TIB200 Gel 10% Cohort 1: Nurofen Gel 10% Cohort 1: Nurofen Tablets Cohort 1: TIB200 Placebo Gel Cohort 2: DCF100 Gel 2% Cohort 2: DCF100 Gel 4% Cohort 2: Voltaren Gel 2% Cohort 2: Voltarol Oral Tablet Cohort 2: DCF100 Placebo Gel Cohort 3: SPR300 Gel (15%:7%) Cohort 3: SPR300 Placebo Gel
Hide Arm/Group Description

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: 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: 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 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: 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: 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: 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: 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 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: 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 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.

All-Cause Mortality
Cohort 1: TIB200 Gel 10% Cohort 1: Nurofen Gel 10% Cohort 1: Nurofen Tablets Cohort 1: TIB200 Placebo Gel Cohort 2: DCF100 Gel 2% Cohort 2: DCF100 Gel 4% Cohort 2: Voltaren Gel 2% Cohort 2: Voltarol Oral Tablet Cohort 2: DCF100 Placebo Gel Cohort 3: SPR300 Gel (15%:7%) Cohort 3: SPR300 Placebo Gel
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)      0/20 (0.00%)      0/20 (0.00%)      0/20 (0.00%)      0/20 (0.00%)      0/20 (0.00%)      0/20 (0.00%)      0/20 (0.00%)      0/20 (0.00%)      0/20 (0.00%)      0/20 (0.00%)    
Hide Serious Adverse Events
Cohort 1: TIB200 Gel 10% Cohort 1: Nurofen Gel 10% Cohort 1: Nurofen Tablets Cohort 1: TIB200 Placebo Gel Cohort 2: DCF100 Gel 2% Cohort 2: DCF100 Gel 4% Cohort 2: Voltaren Gel 2% Cohort 2: Voltarol Oral Tablet Cohort 2: DCF100 Placebo Gel Cohort 3: SPR300 Gel (15%:7%) Cohort 3: SPR300 Placebo Gel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/20 (0.00%)      0/20 (0.00%)      0/20 (0.00%)      0/20 (0.00%)      0/20 (0.00%)      0/20 (0.00%)      0/20 (0.00%)      0/20 (0.00%)      0/20 (0.00%)      0/20 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cohort 1: TIB200 Gel 10% Cohort 1: Nurofen Gel 10% Cohort 1: Nurofen Tablets Cohort 1: TIB200 Placebo Gel Cohort 2: DCF100 Gel 2% Cohort 2: DCF100 Gel 4% Cohort 2: Voltaren Gel 2% Cohort 2: Voltarol Oral Tablet Cohort 2: DCF100 Placebo Gel Cohort 3: SPR300 Gel (15%:7%) Cohort 3: SPR300 Placebo Gel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/20 (25.00%)      5/20 (25.00%)      1/20 (5.00%)      1/20 (5.00%)      1/20 (5.00%)      1/20 (5.00%)      0/20 (0.00%)      2/20 (10.00%)      0/20 (0.00%)      3/20 (15.00%)      1/20 (5.00%)    
Gastrointestinal disorders                       
toothache  1  0/20 (0.00%)  0 0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0
headache  1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0
Nausea  1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0
Soft Stools  1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0
General disorders                       
Pain Burning  1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 2/20 (10.00%)  2 0/20 (0.00%)  0
Infections and infestations                       
Commom Cold  1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0
Musculoskeletal and connective tissue disorders                       
Back pain  1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0
Renal and urinary disorders                       
Frequency of Micturation Increased  1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                       
Runny Nose  1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 1/20 (5.00%)  1
Skin and subcutaneous tissue disorders                       
Itching  1  1/20 (5.00%)  1 4/20 (20.00%)  4 0/20 (0.00%)  0 0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0
Erythematous Rash  1  0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Vascular disorders                       
Hot Flush  1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0
1
Term from vocabulary, MedDRA (17.1)
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director of Clinical Development
Organization: Futura Medical Developments Limited
Phone: 01483685683
EMail: tim.holland@futuramedical.com
Layout table for additonal information
Responsible Party: Futura Medical Developments Ltd.
ClinicalTrials.gov Identifier: NCT02666846    
Other Study ID Numbers: FM52
First Submitted: January 20, 2016
First Posted: January 28, 2016
Results First Submitted: December 14, 2019
Results First Posted: September 29, 2020
Last Update Posted: January 27, 2021