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Trial record 11 of 456 for:    DICLOFENAC

Comparison of the Bioavailability of Diclofenac in a Combination Product (Diclofenac 2% + Capsaicin 0.075% Topical Gel) With Two Diclofenac Only Products, Diclofenac Mono Gel 2% and Voltarol® 12 Hour Emulgel 2.32% Gel, in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT03074162
Recruitment Status : Completed
First Posted : March 8, 2017
Results First Posted : March 1, 2019
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Healthy
Interventions Drug: Diclofenac Sodium
Drug: Diclofenac & Capsaicin
Drug: Diclofenac Sodium Topical Gel
Enrollment 48
Recruitment Details This was an open-label, randomized, 3-treatment periods (each of which included a multiple-dose period of 7 days [twice daily and only in the morning on Day 7] and two pharmacokinetic profile periods of 12 hours [Day 1] and 24 hours [Day 7]) separated by a wash out period of at least 7 days.
Pre-assignment Details All subjects were screened for eligibility to participate in the trial. Subjects attended the trial site and it was ensured that they met all strictly implemented inclusion/exclusion criteria. Subjects were not to be randomised to trial treatment if any one of the specific entry criteria were violated.
Arm/Group Title A-B-R B-R-A R-A-B R-B-A A-R-B B-A-R
Hide Arm/Group Description

Test A: Diclofenac Mono Gel 2% (B151002900/EI4659); Test B: Combination of Diclofenac 2% + Capsaicin 0.075% Topical Gel (B151002897/EI4699); Reference: Voltarol® Emulgel 2.32% (B161000473/parental batch R03717A)

Subjects were administered 2 grams of Diclofenac 2% immediate release topical mono gel in period 1, followed by period 2 with 2 grams of Combination of Diclofenac 2% and Capsaicin 0.075% immediate release topical gel and in period 3 with 2 grams of Voltarol® Emulgel 2.32% Gel with 2.32% diclofenac topical gel, each treatment twice daily for multiple dose period of 6 days and only once in the morning on Day 7.

All treatment periods were separated by a wash-out period of at least 7 days.

Test B: Combination of Diclofenac 2% + Capsaicin 0.075% Topical Gel (B151002897/EI4699); Reference: Voltarol® Emulgel 2.32% (B161000473/parental batch R03717A); Test A: Diclofenac Mono Gel 2% (B151002900/EI4659)

Subjects were administered 2 grams of Combination of Diclofenac 2% and Capsaicin 0.075% immediate release topical gel in period 1, followed by period 2 with 2 grams of Voltarol® Emulgel 2.32% Gel with 2.32% diclofenac topical gel and in period 3 with 2 grams of Diclofenac 2% immediate release topical mono gel, each treatment twice daily for multiple dose period of 6 days and only once in the morning on Day 7.

All treatment periods were separated by a wash-out period of at least 7 days.

Reference: Voltarol® Emulgel 2.32% (B161000473/parental batch R03717A); Test A: Diclofenac Mono Gel 2% (B151002900/EI4659); Test B: Combination of Diclofenac 2% + Capsaicin 0.075% Topical Gel (B151002897/EI4699)

Subjects were administered 2 grams of Voltarol® Emulgel 2.32% Gel with 2.32% diclofenac topical gel in period 1, followed by period 2 with 2 grams of Diclofenac 2% immediate release topical mono gel and in period 3 with 2 grams of Combination of Diclofenac 2% and Capsaicin 0.075% immediate release topical gel, each treatment twice daily for multiple dose period of 6 days and only once in the morning on Day 7.

All treatment periods were separated by a wash-out period of at least 7 days.

Reference: Voltarol® Emulgel 2.32% (B161000473/parental batch R03717A); Test B: Combination of Diclofenac 2% + Capsaicin 0.075% Topical Gel (B151002897/EI4699); Test A: Diclofenac Mono Gel 2% (B151002900/EI4659)

Subjects were administered 2 grams of Voltarol® Emulgel 2.32% Gel with 2.32% diclofenac topical gel in period 1, followed by period 2 with 2 grams of Combination of Diclofenac 2% and Capsaicin 0.075% immediate release topical gel and in period 3 with 2 grams of Diclofenac 2% immediate release topical mono gel, each treatment twice daily for multiple dose period of 6 days and only once in the morning on Day 7.

All treatment periods were separated by a wash-out period of at least 7 days.

Test A: Diclofenac Mono Gel 2% (B151002900/EI4659); Reference: Voltarol® Emulgel 2.32% (B161000473/parental batch R03717A); Test B: Combination of Diclofenac 2% + Capsaicin 0.075% Topical Gel (B151002897/EI4699)

Subjects were administered 2 grams of Diclofenac 2% immediate release topical mono gel in period 1, followed by period 2 with 2 grams of Voltarol® Emulgel 2.32% Gel with 2.32% diclofenac topical gel and in period 3 with 2 grams of Combination of Diclofenac 2% and Capsaicin 0.075% immediate release topical gel, each treatment twice daily for multiple dose period of 6 days and only once in the morning on Day 7.

All treatment periods were separated by a wash-out period of at least 7 days.

Test B: Combination of Diclofenac 2% + Capsaicin 0.075% Topical Gel (B151002897/EI4699); Test A: Diclofenac Mono Gel 2% (B151002900/EI4659); Reference: Voltarol® Emulgel 2.32% (B161000473/parental batch R03717A)

Subjects were administered 2 grams of Combination of Diclofenac 2% and Capsaicin 0.075% immediate release topical gel in period 1, followed by period 2 with 2 grams of Diclofenac 2% immediate release topical mono gel and in period 3 with 2 grams of Voltarol® Emulgel 2.32% Gel with 2.32% diclofenac topical gel, each treatment twice daily for multiple dose period of 6 days and only once in the morning on Day 7.

All treatment periods were separated by a wash-out period of at least 7 days.

Period Title: Period 1 Including Washout 1
Started 8 8 8 8 8 8
Completed 8 8 7 8 8 8
Not Completed 0 0 1 0 0 0
Reason Not Completed
Withdrawal by Subject             0             0             1             0             0             0
Period Title: Period 2 Including Washout 2
Started 8 8 7 8 8 8
Completed 8 8 6 8 8 7
Not Completed 0 0 1 0 0 1
Reason Not Completed
Withdrawal by Subject             0             0             1             0             0             1
Period Title: Period 3
Started 8 8 6 8 8 7
Completed 7 8 6 8 7 7
Not Completed 1 0 0 0 1 0
Reason Not Completed
Withdrawal by Subject             1             0             0             0             1             0
Arm/Group Title A-B-R B-R-A R-A-B R-B-A A-R-B B-A-R Total
Hide Arm/Group Description

Test A: Diclofenac Mono Gel 2% (B151002900/EI4659); Test B: Combination of Diclofenac 2% + Capsaicin 0.075% Topical Gel (B151002897/EI4699); Reference: Voltarol® Emulgel 2.32% (B161000473/parental batch R03717A)

Subjects were administered 2 grams of Diclofenac 2% immediate release topical mono gel in period 1, followed by period 2 with 2 grams of Combination of Diclofenac 2% and Capsaicin 0.075% immediate release topical gel and in period 3 with 2 grams of Voltarol® Emulgel 2.32% Gel with 2.32% diclofenac topical gel, each treatment twice daily for multiple dose period of 6 days and only once in the morning on Day 7.

All treatment periods were separated by a wash-out period of at least 7 days.

Test B: Combination of Diclofenac 2% + Capsaicin 0.075% Topical Gel (B151002897/EI4699); Reference: Voltarol® Emulgel 2.32% (B161000473/parental batch R03717A); Test A: Diclofenac Mono Gel 2% (B151002900/EI4659)

Subjects were administered 2 grams of Combination of Diclofenac 2% and Capsaicin 0.075% immediate release topical gel in period 1, followed by period 2 with 2 grams of Voltarol® Emulgel 2.32% Gel with 2.32% diclofenac topical gel and in period 3 with 2 grams of Diclofenac 2% immediate release topical mono gel, each treatment twice daily for multiple dose period of 6 days and only once in the morning on Day 7.

All treatment periods were separated by a wash-out period of at least 7 days.

Reference: Voltarol® Emulgel 2.32% (B161000473/parental batch R03717A); Test A: Diclofenac Mono Gel 2% (B151002900/EI4659); Test B: Combination of Diclofenac 2% + Capsaicin 0.075% Topical Gel (B151002897/EI4699)

Subjects were administered 2 grams of Voltarol® Emulgel 2.32% Gel with 2.32% diclofenac topical gel in period 1, followed by period 2 with 2 grams of Diclofenac 2% immediate release topical mono gel and in period 3 with 2 grams of Combination of Diclofenac 2% and Capsaicin 0.075% immediate release topical gel, each treatment twice daily for multiple dose period of 6 days and only once in the morning on Day 7.

All treatment periods were separated by a wash-out period of at least 7 days.

Reference: Voltarol® Emulgel 2.32% (B161000473/parental batch R03717A); Test B: Combination of Diclofenac 2% + Capsaicin 0.075% Topical Gel (B151002897/EI4699); Test A: Diclofenac Mono Gel 2% (B151002900/EI4659)

Subjects were administered 2 grams of Voltarol® Emulgel 2.32% Gel with 2.32% diclofenac topical gel in period 1, followed by period 2 with 2 grams of Combination of Diclofenac 2% and Capsaicin 0.075% immediate release topical gel and in period 3 with 2 grams of Diclofenac 2% immediate release topical mono gel, each treatment twice daily for multiple dose period of 6 days and only once in the morning on Day 7.

All treatment periods were separated by a wash-out period of at least 7 days.

Test A: Diclofenac Mono Gel 2% (B151002900/EI4659); Reference: Voltarol® Emulgel 2.32% (B161000473/parental batch R03717A); Test B: Combination of Diclofenac 2% + Capsaicin 0.075% Topical Gel (B151002897/EI4699)

Subjects were administered 2 grams of Diclofenac 2% immediate release topical mono gel in period 1, followed by period 2 with 2 grams of Voltarol® Emulgel 2.32% Gel with 2.32% diclofenac topical gel and in period 3 with 2 grams of Combination of Diclofenac 2% and Capsaicin 0.075% immediate release topical gel, each treatment twice daily for multiple dose period of 6 days and only once in the morning on Day 7.

All treatment periods were separated by a wash-out period of at least 7 days.

Test B: Combination of Diclofenac 2% + Capsaicin 0.075% Topical Gel (B151002897/EI4699); Test A: Diclofenac Mono Gel 2% (B151002900/EI4659); Reference: Voltarol® Emulgel 2.32% (B161000473/parental batch R03717A)

Subjects were administered 2 grams of Combination of Diclofenac 2% and Capsaicin 0.075% immediate release topical gel in period 1, followed by period 2 with 2 grams of Diclofenac 2% immediate release topical mono gel and in period 3 with 2 grams of Voltarol® Emulgel 2.32% Gel with 2.32% diclofenac topical gel, each treatment twice daily for multiple dose period of 6 days and only once in the morning on Day 7.

All treatment periods were separated by a wash-out period of at least 7 days.

Total of all reporting groups
Overall Number of Baseline Participants 8 8 8 8 8 8 48
Hide Baseline Analysis Population Description
Safety Population: All subjects who received at least one dose of investigational medicinal product (IMP) were included in the safety analysis of the study.
Age, Continuous   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 8 participants 8 participants 8 participants 8 participants 8 participants 48 participants
30.9  (9.43) 29.4  (10.04) 27.6  (7.84) 28.5  (8.82) 22.5  (3.38) 26.0  (8.16) 27.5  (8.24)
[1]
Measure Description: Age at the time of signing informed consent form is presented.
[2]
Measure Analysis Population Description: Safety Population
Sex: Female, Male   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 8 participants 8 participants 8 participants 8 participants 48 participants
Female
1
  12.5%
2
  25.0%
4
  50.0%
3
  37.5%
1
  12.5%
3
  37.5%
14
  29.2%
Male
7
  87.5%
6
  75.0%
4
  50.0%
5
  62.5%
7
  87.5%
5
  62.5%
34
  70.8%
[1]
Measure Description: Number of subjects is categorized as Male or Female.
[2]
Measure Analysis Population Description: Safety Population
Race (NIH/OMB)   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 8 participants 8 participants 8 participants 8 participants 48 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
  50.0%
4
  50.0%
4
  50.0%
4
  50.0%
4
  50.0%
4
  50.0%
24
  50.0%
White
4
  50.0%
4
  50.0%
4
  50.0%
4
  50.0%
4
  50.0%
4
  50.0%
24
  50.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: Number of subjects is categorized for race data. Ethnicity data were not collected. Caucasian race is entered as White.
[2]
Measure Analysis Population Description: Safety Population
1.Primary Outcome
Title Area Under the Plasma Concentration-time Curve (AUC) Over One Dosing Interval for Diclofenac at Steady State (AUC0-τ,ss) (τ = 12 Hours) (Day 7)
Hide Description AUC0-τ,ss, Area under the plasma concentration-time curve (AUC) over one dosing interval at steady state for diclofenac at day 7 (τ = 12 hours). Stratification by race was analysed using a supportive Analysis of Variance (ANOVA) yielding point estimates for each underlying pairwise comparison analog to the main analysis. As the resulting two Least Square Means and Geometric Means (gMeans) per treatment and race are very similar, only gMeans per treatment and race are presented.
Time Frame Pharmacokinetic samples were collected on Day 7 at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours after the drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population (PK): This population consists of all subjects in the safety population for whom at least one of area under the plasma concentration-time curve over one dosing interval or maximum steady-state plasma drug concentration during a dosage interval could be calculated for one treatment and who had no major protocol deviations.
Arm/Group Title Diclofenac 2% (A) Diclofenac 2% + Capsaicin 0.075% (B) Voltarol® 2.32% Gel (R)
Hide Arm/Group Description:
Subjects were administered 2 grams of Diclofenac 2% immediate release topical mono gel twice daily for 6 days and only once in the morning on Day 7.
Subjects were administered 2 grams of Combination of Diclofenac 2% and Capsaicin 0.075% immediate release topical gel twice daily for 6 days and only once in the morning on Day 7.
Subjects were administered 2 grams of Voltarol® Emulgel 2.32% Gel with 2.32% diclofenac topical gel twice daily for 6 days and only once in the morning on Day 7.
Overall Number of Participants Analyzed 47 46 47
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hour*nanogram/millilitre (h*ng/mL)
Overall Number Analyzed 46 participants 45 participants 46 participants
46.855
(66.01%)
40.175
(59.38%)
83.644
(64.35%)
By race: Black Number Analyzed 24 participants 23 participants 22 participants
60.930
(58.76%)
53.628
(47.37%)
105.670
(42.13%)
By race: Caucasian Number Analyzed 22 participants 22 participants 24 participants
35.182
(57.46%)
29.704
(51.32%)
67.513
(73.15%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Diclofenac 2% + Capsaicin 0.075% (B), Voltarol® 2.32% Gel (R)
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments The statistical model was an variance (ANOVA) on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment for comparison of B with R.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments Only the data for the comparison under investigation were included in the statistical analysis.
Method of Estimation Estimation Parameter Geometric Mean (gMean) Ratio (%)
Estimated Value 45.54
Confidence Interval (2-Sided) 90%
40.11 to 51.70
Parameter Dispersion
Type: Standard Error of the Mean
Value: 35.99
Estimation Comments gMean Ratio=(B/R) *100. Standard Error of the mean is actually intra-individual geometric coefficient of variation.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Diclofenac 2% (A), Diclofenac 2% + Capsaicin 0.075% (B)
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment for comparison of B with A.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments Only the data for the comparison under investigation were included in the statistical analysis.
Method of Estimation Estimation Parameter Geometric Mean (gMean) Ratio (%)
Estimated Value 85.56
Confidence Interval (2-Sided) 90%
74.11 to 98.77
Parameter Dispersion
Type: Standard Error of the Mean
Value: 42.05
Estimation Comments gMean Ratio=(B/A) *100. Standard Error of the mean is actually intra-individual geometric coefficient of variation
2.Primary Outcome
Title Maximum Plasma Concentration During a Dosage Interval (Cmax,ss) Obtained Directly From the Concentration-time Data for Diclofenac at Steady State (Day 7)
Hide Description Cmax,ss, Maximum plasma of diclofenac concentration during a dosage interval obtained directly from the concentration-time data at steady state for diclofenac on day 7. Stratification by race was analysed using a supportive Analysis of Variance (ANOVA) yielding point estimates for each underlying pairwise comparison analog to the main analysis. As the resulting two Least Square Means and gMeans per treatment and race are very similar, only gMeans per treatment and race are presented.
Time Frame Pharmacokinetic samples were collected on Day 7 at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours after the drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population (PK): This population consists of all subjects in the safety population for whom at least one of area under the plasma concentration-time curve over one dosing interval or maximum steady-state plasma drug concentration during a dosage interval could be calculated for one treatment and who had no major protocol deviations.
Arm/Group Title Diclofenac 2% (A) Diclofenac 2% + Capsaicin 0.075% (B) Voltarol® 2.32% Gel (R)
Hide Arm/Group Description:
Subjects were administered 2 grams of Diclofenac 2% immediate release topical mono gel twice daily for 6 days and only once in the morning on Day 7.
Subjects were administered 2 grams of Combination of Diclofenac 2% and Capsaicin 0.075% immediate release topical gel twice daily for 6 days and only once in the morning on Day 7.
Subjects were administered 2 grams of Voltarol® Emulgel 2.32% Gel with 2.32% diclofenac topical gel twice daily for 6 days and only once in the morning on Day 7.
Overall Number of Participants Analyzed 47 46 47
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanogram/millilitre (ng/mL)
Overall Number Analyzed 46 participants 45 participants 46 participants
6.7825
(100.12%)
5.6964
(66.98%)
10.8330
(70.99%)
By Race: Black Number Analyzed 24 participants 23 participants 22 participants
9.3923
(63.72%)
7.3863
(63.86%)
14.8040
(49.82%)
By Race: Caucasian Number Analyzed 22 participants 22 participants 24 participants
4.7551
(116.89%)
4.3416
(55.32%)
8.1371
(71.96%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Diclofenac 2% + Capsaicin 0.075% (B), Voltarol® 2.32% Gel (R)
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment for comparison of B with R.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments Only the data for the comparison under investigation were included in the statistical analysis.
Method of Estimation Estimation Parameter Geometric Mean (gMean) Ratio (%)
Estimated Value 49.60
Confidence Interval (2-Sided) 90%
43.39 to 56.71
Parameter Dispersion
Type: Standard Error of the Mean
Value: 38.13
Estimation Comments gMean Ratio=(B/R) *100. Standard Error of the mean is actually intra-individual geometric coefficient of variation.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Diclofenac 2% (A), Diclofenac 2% + Capsaicin 0.075% (B)
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment for comparison of B with A.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments Only the data for the comparison under investigation were included in the statistical analysis.
Method of Estimation Estimation Parameter Geometric Mean (gMean) Ratio (%)
Estimated Value 83.57
Confidence Interval (2-Sided) 90%
66.33 to 105.31
Parameter Dispersion
Type: Standard Error of the Mean
Value: 72.45
Estimation Comments gMean Ratio=(B/A) *100. Standard Error of the mean is actually intra-individual geometric coefficient of variation
3.Secondary Outcome
Title Time to Maximum Observed Plasma Concentration at Steady State for Diclofenac at Steady State (Tmax,ss) (Day 7)
Hide Description tmax,ss, Time to maximum observed plasma concentration at steady state for diclofenac at day 7 (tmax,ss). Descriptive statistics by race are reported in addition.
Time Frame Pharmacokinetic samples were collected on Day 7 at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours after the drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population (PK): This population consists of all subjects in the safety population for whom at least one of area under the plasma concentration-time curve over one dosing interval or maximum steady-state plasma drug concentration during a dosage interval could be calculated for one treatment and who had no major protocol deviations.
Arm/Group Title Diclofenac 2% (A) Diclofenac 2% + Capsaicin 0.075% (B) Voltarol® 2.32% Gel (R)
Hide Arm/Group Description:
Subjects were administered 2 grams of Diclofenac 2% immediate release topical mono gel twice daily for 6 days and only once in the morning on Day 7.
Subjects were administered 2 grams of Combination of Diclofenac 2% and Capsaicin 0.075% immediate release topical gel twice daily for 6 days and only once in the morning on Day 7.
Subjects were administered 2 grams of Voltarol® Emulgel 2.32% Gel with 2.32% diclofenac topical gel twice daily for 6 days and only once in the morning on Day 7.
Overall Number of Participants Analyzed 47 46 47
Median (Full Range)
Unit of Measure: Hour (h)
Overall Number Analyzed 46 participants 45 participants 46 participants
0.75
(0 to 12)
1.00
(0 to 12)
0.00
(0 to 12)
By Race: Black Number Analyzed 24 participants 23 participants 22 participants
0.00
(0 to 10)
0.50
(0 to 10.02)
0.00
(0 to 8)
By Race: Caucasian Number Analyzed 22 participants 22 participants 24 participants
2.00
(0 to 12)
3.50
(0 to 12)
4.00
(0 to 12)
4.Secondary Outcome
Title Average Plasma Concentration (Cav,ss) for Diclofenac at Steady State
Hide Description Average plasma concentration (Cav,ss) calculated as AUC0-t,ss divided by τ=12 hours (τ is the duration of the dosing interval). Descriptive statistics by race are reported in addition.
Time Frame Pharmacokinetic samples were collected on Day 7 at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours after the drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population (PK): This population consists of all subjects in the safety population for whom at least one of area under the plasma concentration-time curve over one dosing interval or maximum steady-state plasma drug concentration during a dosage interval could be calculated for one treatment and who had no major protocol deviations.
Arm/Group Title Diclofenac 2% (A) Diclofenac 2% + Capsaicin 0.075% (B) Voltarol® 2.32% Gel (R)
Hide Arm/Group Description:
Subjects were administered 2 grams of Diclofenac 2% immediate release topical mono gel twice daily for 6 days and only once in the morning on Day 7.
Subjects were administered 2 grams of Combination of Diclofenac 2% and Capsaicin 0.075% immediate release topical gel twice daily for 6 days and only once in the morning on Day 7.
Subjects were administered 2 grams of Voltarol® Emulgel 2.32% Gel with 2.32% diclofenac topical gel twice daily for 6 days and only once in the morning on Day 7.
Overall Number of Participants Analyzed 46 46 47
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram/ millilitre (ng/mL)
Overall Number Analyzed 46 participants 45 participants 46 participants
3.9046
(66.02%)
3.3480
(59.38%)
6.9702
(64.34%)
By Race: Black Number Analyzed 24 participants 23 participants 22 participants
5.0775
(58.78%)
4.4691
(47.37%)
8.8055
(42.13%)
By Race: Caucasian Number Analyzed 22 participants 22 participants 24 participants
2.9317
(57.46%)
2.4754
(51.32%)
5.6259
(73.14%)
5.Secondary Outcome
Title Percentage Peak-trough Fluctuation (%PTF), Calculated as [100*(Cmax,ss – Cpre,ss)/Cav,ss]
Hide Description Percentage peak-trough fluctuation (%PTF) which was calculated as [100*(Cmax,ss – Cpre,ss)/Cav,ss] for Diclofenac. Descriptive statistics by race are reported in addition.
Time Frame Pharmacokinetic samples were collected on Day 7 at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours after the drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population (PK): This population consists of all subjects in the safety population for whom at least one of area under the plasma concentration-time curve over one dosing interval or maximum steady-state plasma drug concentration during a dosage interval could be calculated for one treatment and who had no major protocol deviations.
Arm/Group Title Diclofenac 2% (A) Diclofenac 2% + Capsaicin 0.075% (B) Voltarol® 2.32% Gel (R)
Hide Arm/Group Description:
Subjects were administered 2 grams of Diclofenac 2% immediate release topical mono gel twice daily for 6 days and only once in the morning on Day 7.
Subjects were administered 2 grams of Combination of Diclofenac 2% and Capsaicin 0.075% immediate release topical gel twice daily for 6 days and only once in the morning on Day 7.
Subjects were administered 2 grams of Voltarol® Emulgel 2.32% Gel with 2.32% diclofenac topical gel twice daily for 6 days and only once in the morning on Day 7.
Overall Number of Participants Analyzed 47 46 47
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Percentage of Cav,ss (%)
Overall Number Analyzed 46 participants 45 participants 46 participants
33.95533
(354.42%)
26.69620
(267.21%)
24.75558
(103.66%)
By Race: Black Number Analyzed 24 participants 23 participants 22 participants
48.55712
(96.39%)
15.07128
(320.78%)
25.85257
(123.16%)
By Race: Caucasian Number Analyzed 22 participants 22 participants 24 participants
26.75129
(693.89%)
39.96865
(196.93%)
24.25970
(100.46%)
Time Frame From first drug administration until individual subject’s end of study, up to approximately 38 days.
Adverse Event Reporting Description Safety Population (All subjects who received at least one dose of study medication were included in the safety population) was used for safety analysis.
 
Arm/Group Title Diclofenac 2% (A) Diclofenac 2% + Capsaicin 0.075% (B) Voltarol® 2.32% Gel (R)
Hide Arm/Group Description Subjects were administered 2 grams of Diclofenac 2% immediate release topical mono gel twice daily for 6 days and only once in the morning on Day 7. Subjects were administered 2 grams of Combination of Diclofenac 2% and Capsaicin 0.075% immediate release topical gel twice daily for 6 days and only once in the morning on Day 7. Subjects were administered 2 grams of Voltarol® Emulgel 2.32% Gel with 2.32% diclofenac topical gel twice daily for 6 days and only once in the morning on Day 7.
All-Cause Mortality
Diclofenac 2% (A) Diclofenac 2% + Capsaicin 0.075% (B) Voltarol® 2.32% Gel (R)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/47 (0.00%)   0/46 (0.00%)   0/47 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Diclofenac 2% (A) Diclofenac 2% + Capsaicin 0.075% (B) Voltarol® 2.32% Gel (R)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/47 (0.00%)   0/46 (0.00%)   0/47 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Diclofenac 2% (A) Diclofenac 2% + Capsaicin 0.075% (B) Voltarol® 2.32% Gel (R)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/47 (19.15%)   44/46 (95.65%)   3/47 (6.38%) 
General disorders       
Application site dryness  1  2/47 (4.26%)  3/46 (6.52%)  0/47 (0.00%) 
Application site erythema  1  3/47 (6.38%)  0/46 (0.00%)  0/47 (0.00%) 
Application site inflammation  1  2/47 (4.26%)  44/46 (95.65%)  0/47 (0.00%) 
Application site pruritus  1  6/47 (12.77%)  3/46 (6.52%)  2/47 (4.26%) 
Infections and infestations       
Viral upper respiratory tract infection  1  0/47 (0.00%)  3/46 (6.52%)  0/47 (0.00%) 
Nervous system disorders       
Headache  1  0/47 (0.00%)  0/46 (0.00%)  3/47 (6.38%) 
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI’s intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim, Call Centre
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03074162     History of Changes
Other Study ID Numbers: 1358.2
First Submitted: March 3, 2017
First Posted: March 8, 2017
Results First Submitted: August 31, 2018
Results First Posted: March 1, 2019
Last Update Posted: March 1, 2019