Trial Outcomes & Findings for Clinical Investigation of Galnobax® for the Treatment of Diabetic Foot Ulcers (NCT NCT01113515)
NCT ID: NCT01113515
Last Updated: 2024-05-20
Results Overview
Number of participant with adverse events (AEs) till end of follow-up phase in different groups
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
44 participants
Primary outcome timeframe
Till end of follow up period (Week 25)
Results posted on
2024-05-20
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo gel
|
Galnobax 20% QD
Esmolol Hydrochloride (Galnobax) 20% gel once daily
|
Galnobax 20% BID
Esmolol Hydrochloride (Galnobax) 20% gel twice daily
|
Galnobax 14% BID
Esmolol Hydrochloride (Galnobax) 14% gel twice daily
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
9
|
14
|
11
|
|
Overall Study
COMPLETED
|
10
|
9
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Investigation of Galnobax® for the Treatment of Diabetic Foot Ulcers
Baseline characteristics by cohort
| Measure |
Placebo
n=10 Participants
Placebo gel
|
Galnobax 20% QD
n=9 Participants
Esmolol Hydrochloride (Galnobax) 20% gel once daily
|
Galnobax 20% BID
n=14 Participants
Esmolol Hydrochloride (Galnobax) 20% gel twice daily
|
Galnobax 14% BID
n=11 Participants
Esmolol Hydrochloride (Galnobax) 14% gel twice daily
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
53.3 years
STANDARD_DEVIATION 9.37 • n=5 Participants
|
50.0 years
STANDARD_DEVIATION 5.85 • n=7 Participants
|
56.2 years
STANDARD_DEVIATION 11.56 • n=5 Participants
|
53.0 years
STANDARD_DEVIATION 7.75 • n=4 Participants
|
53.5 years
STANDARD_DEVIATION 9.17 • n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Region of Enrollment
Malaysia
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
5 participants
n=21 Participants
|
|
Region of Enrollment
India
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
11 participants
n=5 Participants
|
9 participants
n=4 Participants
|
37 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Till end of follow up period (Week 25)Number of participant with adverse events (AEs) till end of follow-up phase in different groups
Outcome measures
| Measure |
Placebo
n=10 Participants
Placebo gel
|
Galnobax 20% QD
n=9 Participants
Esmolol Hydrochloride (Galnobax) 20% gel once daily
|
Galnobax 20% BID
n=14 Participants
Esmolol Hydrochloride (Galnobax) 20% gel twice daily
|
Galnobax 14% BID
n=11 Participants
Esmolol Hydrochloride (Galnobax) 14% gel twice daily
|
|---|---|---|---|---|
|
Safety Outcome
|
1 Participants
|
3 Participants
|
9 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline and end of treatment (Week 12 or 84 +/- 2 days)To evaluate the percent change in ulcer area and ulcer volume from baseline till end of treatment (Week 12) in different groups
Outcome measures
| Measure |
Placebo
n=10 Participants
Placebo gel
|
Galnobax 20% QD
n=9 Participants
Esmolol Hydrochloride (Galnobax) 20% gel once daily
|
Galnobax 20% BID
n=10 Participants
Esmolol Hydrochloride (Galnobax) 20% gel twice daily
|
Galnobax 14% BID
n=10 Participants
Esmolol Hydrochloride (Galnobax) 14% gel twice daily
|
|---|---|---|---|---|
|
Efficacy Outcome
Percent Change in Ulcer Area
|
80.67 percent change
Standard Deviation 34.09
|
82.58 percent change
Standard Deviation 31.57
|
95.80 percent change
Standard Deviation 9.85
|
86.56 percent change
Standard Deviation 35.07
|
|
Efficacy Outcome
Percent Change in Ulcer Volume
|
84.57 percent change
Standard Deviation 32.99
|
55.41 percent change
Standard Deviation 92.31
|
83.36 percent change
Standard Deviation 39.60
|
99.40 percent change
Standard Deviation 1.70
|
SECONDARY outcome
Timeframe: From baseline till end of treatment (Week 12 or 84 +/- 2 days)Time in days taken for closure of wound in different groups from baseline till end of treatment (week 12 or 84 +/- 2 days)
Outcome measures
| Measure |
Placebo
n=6 Participants
Placebo gel
|
Galnobax 20% QD
n=5 Participants
Esmolol Hydrochloride (Galnobax) 20% gel once daily
|
Galnobax 20% BID
n=5 Participants
Esmolol Hydrochloride (Galnobax) 20% gel twice daily
|
Galnobax 14% BID
n=6 Participants
Esmolol Hydrochloride (Galnobax) 14% gel twice daily
|
|---|---|---|---|---|
|
Efficacy Outcome
|
53.5 days
Interval 22.0 to 72.0
|
77 days
Interval 8.0 to 86.0
|
72 days
Interval 23.0 to 84.0
|
49.5 days
Interval 29.0 to 85.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: pre-dose (prior to first study drug application), and at 15 and 30 minutes, 1, 3, 6, 12, and 24 hours after the first study drug application on day 0, weeks 1, 4, and 12 (prior to study drug application).Pharmacokinetic profile of Galnobax® in subset of patients suffering from DFU
Outcome measures
| Measure |
Placebo
n=4 Participants
Placebo gel
|
Galnobax 20% QD
n=4 Participants
Esmolol Hydrochloride (Galnobax) 20% gel once daily
|
Galnobax 20% BID
n=4 Participants
Esmolol Hydrochloride (Galnobax) 20% gel twice daily
|
Galnobax 14% BID
n=4 Participants
Esmolol Hydrochloride (Galnobax) 14% gel twice daily
|
|---|---|---|---|---|
|
Pharmacokinetic Measurements
|
0.0 Cmax (ng/mL) of Esmolol acid
Standard Deviation 0.0
|
78.451 Cmax (ng/mL) of Esmolol acid
Standard Deviation 83.176
|
113.802 Cmax (ng/mL) of Esmolol acid
Standard Deviation 117.383
|
340.018 Cmax (ng/mL) of Esmolol acid
Standard Deviation 430.944
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Galnobax 20% QD
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Galnobax 20% BID
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Galnobax 14% BID
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=10 participants at risk
Placebo gel
|
Galnobax 20% QD
n=9 participants at risk
Esmolol Hydrochloride (Galnobax) 20% gel once daily
|
Galnobax 20% BID
n=14 participants at risk
Esmolol Hydrochloride (Galnobax) 20% gel twice daily
|
Galnobax 14% BID
n=11 participants at risk
Esmolol Hydrochloride (Galnobax) 14% gel twice daily
|
|---|---|---|---|---|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/10 • 25 weeks
|
0.00%
0/9 • 25 weeks
|
7.1%
1/14 • Number of events 1 • 25 weeks
|
0.00%
0/11 • 25 weeks
|
|
Infections and infestations
Cellulitis
|
0.00%
0/10 • 25 weeks
|
0.00%
0/9 • 25 weeks
|
7.1%
1/14 • Number of events 1 • 25 weeks
|
0.00%
0/11 • 25 weeks
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/10 • 25 weeks
|
0.00%
0/9 • 25 weeks
|
7.1%
1/14 • Number of events 1 • 25 weeks
|
0.00%
0/11 • 25 weeks
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/10 • 25 weeks
|
0.00%
0/9 • 25 weeks
|
7.1%
1/14 • Number of events 1 • 25 weeks
|
0.00%
0/11 • 25 weeks
|
Other adverse events
| Measure |
Placebo
n=10 participants at risk
Placebo gel
|
Galnobax 20% QD
n=9 participants at risk
Esmolol Hydrochloride (Galnobax) 20% gel once daily
|
Galnobax 20% BID
n=14 participants at risk
Esmolol Hydrochloride (Galnobax) 20% gel twice daily
|
Galnobax 14% BID
n=11 participants at risk
Esmolol Hydrochloride (Galnobax) 14% gel twice daily
|
|---|---|---|---|---|
|
Infections and infestations
Wound infection
|
0.00%
0/10 • 25 weeks
|
0.00%
0/9 • 25 weeks
|
14.3%
2/14 • Number of events 2 • 25 weeks
|
0.00%
0/11 • 25 weeks
|
|
General disorders
Pyrexia
|
0.00%
0/10 • 25 weeks
|
11.1%
1/9 • Number of events 1 • 25 weeks
|
0.00%
0/14 • 25 weeks
|
9.1%
1/11 • Number of events 1 • 25 weeks
|
|
General disorders
Inflammation
|
0.00%
0/10 • 25 weeks
|
0.00%
0/9 • 25 weeks
|
0.00%
0/14 • 25 weeks
|
9.1%
1/11 • Number of events 1 • 25 weeks
|
|
General disorders
Local swelling
|
0.00%
0/10 • 25 weeks
|
0.00%
0/9 • 25 weeks
|
0.00%
0/14 • 25 weeks
|
9.1%
1/11 • Number of events 1 • 25 weeks
|
|
General disorders
Malaise
|
0.00%
0/10 • 25 weeks
|
0.00%
0/9 • 25 weeks
|
7.1%
1/14 • Number of events 1 • 25 weeks
|
0.00%
0/11 • 25 weeks
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/10 • 25 weeks
|
0.00%
0/9 • 25 weeks
|
0.00%
0/14 • 25 weeks
|
9.1%
1/11 • Number of events 1 • 25 weeks
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.00%
0/10 • 25 weeks
|
0.00%
0/9 • 25 weeks
|
7.1%
1/14 • Number of events 1 • 25 weeks
|
0.00%
0/11 • 25 weeks
|
|
Skin and subcutaneous tissue disorders
Skin discoloration
|
0.00%
0/10 • 25 weeks
|
11.1%
1/9 • Number of events 1 • 25 weeks
|
0.00%
0/14 • 25 weeks
|
18.2%
2/11 • Number of events 2 • 25 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/10 • 25 weeks
|
0.00%
0/9 • 25 weeks
|
7.1%
1/14 • Number of events 1 • 25 weeks
|
0.00%
0/11 • 25 weeks
|
|
Cardiac disorders
Palpitation
|
0.00%
0/10 • 25 weeks
|
0.00%
0/9 • 25 weeks
|
7.1%
1/14 • Number of events 1 • 25 weeks
|
0.00%
0/11 • 25 weeks
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/10 • 25 weeks
|
0.00%
0/9 • 25 weeks
|
7.1%
1/14 • Number of events 1 • 25 weeks
|
0.00%
0/11 • 25 weeks
|
|
Investigations
Blood creatinine increase
|
0.00%
0/10 • 25 weeks
|
11.1%
1/9 • Number of events 1 • 25 weeks
|
0.00%
0/14 • 25 weeks
|
0.00%
0/11 • 25 weeks
|
|
Metabolism and nutrition disorders
Hypertriglyceradaemia
|
10.0%
1/10 • Number of events 1 • 25 weeks
|
0.00%
0/9 • 25 weeks
|
0.00%
0/14 • 25 weeks
|
0.00%
0/11 • 25 weeks
|
|
Infections and infestations
Cellulitis
|
0.00%
0/10 • 25 weeks
|
0.00%
0/9 • 25 weeks
|
7.1%
1/14 • Number of events 1 • 25 weeks
|
0.00%
0/11 • 25 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor has prepared an integrated clinical/statistical report. As this was a multicenter study, any publication/presentation of data was to include the entire study population. Publication/presentation of data from individual study centers is not allowed without explicit permission from the sponsor.
- Publication restrictions are in place
Restriction type: OTHER