Trial Outcomes & Findings for Efficacy Trial of 3804-250A in the Prevention of Cold Illnesses (NCT NCT00762476)
NCT ID: NCT00762476
Last Updated: 2012-04-16
Results Overview
Comparison of the total number of incidence of cold illnesses over the course of the study per 100 subjects in each treatment group
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
411 participants
Primary outcome timeframe
10 weeks
Results posted on
2012-04-16
Participant Flow
Participant milestones
| Measure |
Placebo
Modified AV Lotion without active ingredients.
|
3804-250A
Experimental AV Lotion
|
|---|---|---|
|
Overall Study
STARTED
|
206
|
205
|
|
Overall Study
COMPLETED
|
183
|
169
|
|
Overall Study
NOT COMPLETED
|
23
|
36
|
Reasons for withdrawal
| Measure |
Placebo
Modified AV Lotion without active ingredients.
|
3804-250A
Experimental AV Lotion
|
|---|---|---|
|
Overall Study
Adverse Event
|
7
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Protocol Violation
|
5
|
6
|
|
Overall Study
Physician Decision
|
2
|
14
|
|
Overall Study
Withdrawal by Subject
|
6
|
12
|
|
Overall Study
antibiotic use
|
0
|
1
|
|
Overall Study
non-compliance with study visits
|
0
|
2
|
|
Overall Study
Seasonal allergies
|
1
|
0
|
Baseline Characteristics
Efficacy Trial of 3804-250A in the Prevention of Cold Illnesses
Baseline characteristics by cohort
| Measure |
Placebo
n=206 Participants
Modified AV Lotion without active ingredients.
|
3804-250A
n=205 Participants
Experimental AV Lotion
|
Total
n=411 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
203 Participants
n=5 Participants
|
200 Participants
n=7 Participants
|
403 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age Continuous
|
37.3 years
STANDARD_DEVIATION 14.56 • n=5 Participants
|
36.2 years
STANDARD_DEVIATION 14.23 • n=7 Participants
|
36.7 years
STANDARD_DEVIATION 14.39 • n=5 Participants
|
|
Sex: Female, Male
Female
|
150 Participants
n=5 Participants
|
155 Participants
n=7 Participants
|
305 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
206 participants
n=5 Participants
|
205 participants
n=7 Participants
|
411 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 weeksPopulation: All efficacy analyses were performed on the intent-to-treat (ITT).The ITT population included all enrolled subjects who received study treatment.
Comparison of the total number of incidence of cold illnesses over the course of the study per 100 subjects in each treatment group
Outcome measures
| Measure |
Placebo
n=206 Participants
Modified AV Lotion without active ingredients
|
3804-250A
n=205 Participants
Experimental AV Lotion
|
|---|---|---|
|
The Primary Efficacy Endpoint of This Study is the Incidence of Cold Illnesses.
|
47.1 cold illnesses per 100 subjects
|
43.9 cold illnesses per 100 subjects
|
SECONDARY outcome
Timeframe: 10 weeksPopulation: All efficacy analyses were performed on the intent-to-treat (ITT).The ITT population included all enrolled subjects who received study treatment.
The incidence of rhinovirus infections
Outcome measures
| Measure |
Placebo
n=206 Participants
Modified AV Lotion without active ingredients
|
3804-250A
n=205 Participants
Experimental AV Lotion
|
|---|---|---|
|
Rhinovirus Infections.
|
58.7 rhinovirus infections per 100 subjects
|
59.0 rhinovirus infections per 100 subjects
|
SECONDARY outcome
Timeframe: 10 weeksPopulation: All efficacy analyses were performed on the intent-to-treat (ITT).The ITT population included all enrolled subjects who received study treatment.
The incidence of rhinovirus-associated cold illnesses.
Outcome measures
| Measure |
Placebo
n=206 Participants
Modified AV Lotion without active ingredients
|
3804-250A
n=205 Participants
Experimental AV Lotion
|
|---|---|---|
|
Rhinovirus-associated Colds
|
24.3 RV-associated cold illnesses per 100 sub
|
20.0 RV-associated cold illnesses per 100 sub
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 23 other events
Deaths: 0 deaths
3804-250A
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=206 participants at risk
Modified AV Lotion without active ingredients.
|
3804-250A
n=205 participants at risk
Experimental AV Lotion
|
|---|---|---|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.49%
1/206 • Number of events 1 • 10 weeks
|
0.00%
0/205 • 10 weeks
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.49%
1/206 • Number of events 2 • 10 weeks
|
0.00%
0/205 • 10 weeks
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.49%
1/206 • Number of events 1 • 10 weeks
|
0.00%
0/205 • 10 weeks
|
|
Injury, poisoning and procedural complications
Nerve injury
|
0.49%
1/206 • Number of events 1 • 10 weeks
|
0.00%
0/205 • 10 weeks
|
|
Injury, poisoning and procedural complications
excoriation
|
0.49%
1/206 • Number of events 2 • 10 weeks
|
0.00%
0/205 • 10 weeks
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.49%
1/206 • Number of events 1 • 10 weeks
|
0.00%
0/205 • 10 weeks
|
Other adverse events
| Measure |
Placebo
n=206 participants at risk
Modified AV Lotion without active ingredients.
|
3804-250A
n=205 participants at risk
Experimental AV Lotion
|
|---|---|---|
|
General disorders
Application site pruritus
|
0.49%
1/206 • Number of events 2 • 10 weeks
|
3.4%
7/205 • Number of events 8 • 10 weeks
|
|
General disorders
Application site vesicles
|
0.97%
2/206 • Number of events 2 • 10 weeks
|
2.0%
4/205 • Number of events 6 • 10 weeks
|
|
Injury, poisoning and procedural complications
Skin laceration
|
11.2%
23/206 • Number of events 32 • 10 weeks
|
7.8%
16/205 • Number of events 20 • 10 weeks
|
|
Injury, poisoning and procedural complications
Excoriation
|
6.8%
14/206 • Number of events 22 • 10 weeks
|
6.3%
13/205 • Number of events 21 • 10 weeks
|
|
Injury, poisoning and procedural complications
thermal burn
|
5.8%
12/206 • Number of events 13 • 10 weeks
|
3.9%
8/205 • Number of events 9 • 10 weeks
|
|
Injury, poisoning and procedural complications
Scratch
|
3.4%
7/206 • Number of events 8 • 10 weeks
|
3.4%
7/205 • Number of events 9 • 10 weeks
|
|
Injury, poisoning and procedural complications
Open wound
|
2.9%
6/206 • Number of events 6 • 10 weeks
|
1.5%
3/205 • Number of events 3 • 10 weeks
|
|
Nervous system disorders
Headache
|
3.9%
8/206 • Number of events 11 • 10 weeks
|
2.9%
6/205 • Number of events 7 • 10 weeks
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
2.4%
5/206 • Number of events 7 • 10 weeks
|
0.49%
1/205 • Number of events 1 • 10 weeks
|
|
Infections and infestations
Oral herpes
|
1.9%
4/206 • Number of events 4 • 10 weeks
|
0.49%
1/205 • Number of events 1 • 10 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period 1 year after study completion.
- Publication restrictions are in place
Restriction type: OTHER