Trial Outcomes & Findings for Safety, Efficacy and Pharmacokinetics (PK) Study of WR 279,396 Versus Paromomycin for Treatment of Cutaneous Leishmaniasis (Peru-PK) (NCT NCT01032382)
NCT ID: NCT01032382
Last Updated: 2015-07-16
Results Overview
Final clinical cure was defined as follows: 1. Subject has initial clinical cure (100% re-epithelialization of index lesion by nominal Day 63); OR, 2. Subject has initial clinical improvement (\> 50% re-epithelialization of index lesion by nominal Day 63 followed by 100% re-epithelialization of the index lesion on or before nominal Day 100; AND, 3. Subject has no relapse of index lesion by Day 168. Relapse was defined as an index lesion meeting the criteria for initial clinical cure that had any new ulceration/nodule (\> 0 x 0 mm measurement) by nominal day 168, or an index lesion meeting the criteria for initial clinical improvement that subsequently enlarged by nominal Day 168.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Initial clinical cure by day 63 and no relapse by day 168
Results posted on
2015-07-16
Participant Flow
Participant milestones
| Measure |
Paromomycin Alone Treatment
Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
|
WR 279,396
WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
14
|
|
Overall Study
COMPLETED
|
11
|
9
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
| Measure |
Paromomycin Alone Treatment
Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
|
WR 279,396
WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
|
|---|---|---|
|
Overall Study
Disease dissemination
|
1
|
1
|
|
Overall Study
Treatment failure
|
3
|
1
|
|
Overall Study
Index lesion relapse
|
1
|
3
|
Baseline Characteristics
Safety, Efficacy and Pharmacokinetics (PK) Study of WR 279,396 Versus Paromomycin for Treatment of Cutaneous Leishmaniasis (Peru-PK)
Baseline characteristics by cohort
| Measure |
Paromomycin Alone Treatment
n=16 Participants
Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
|
WR 279,396
n=14 Participants
WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
20.7 years
STANDARD_DEVIATION 16.2 • n=93 Participants
|
18.2 years
STANDARD_DEVIATION 15.1 • n=4 Participants
|
19.5 years
STANDARD_DEVIATION 15.5 • n=27 Participants
|
|
Age, Customized
Adults (18+ years)
|
5 participants
n=93 Participants
|
4 participants
n=4 Participants
|
9 participants
n=27 Participants
|
|
Age, Customized
Children (12 to 17 years)
|
5 participants
n=93 Participants
|
3 participants
n=4 Participants
|
8 participants
n=27 Participants
|
|
Age, Customized
Children (5 to 11 years)
|
6 participants
n=93 Participants
|
7 participants
n=4 Participants
|
13 participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Initial clinical cure by day 63 and no relapse by day 168Final clinical cure was defined as follows: 1. Subject has initial clinical cure (100% re-epithelialization of index lesion by nominal Day 63); OR, 2. Subject has initial clinical improvement (\> 50% re-epithelialization of index lesion by nominal Day 63 followed by 100% re-epithelialization of the index lesion on or before nominal Day 100; AND, 3. Subject has no relapse of index lesion by Day 168. Relapse was defined as an index lesion meeting the criteria for initial clinical cure that had any new ulceration/nodule (\> 0 x 0 mm measurement) by nominal day 168, or an index lesion meeting the criteria for initial clinical improvement that subsequently enlarged by nominal Day 168.
Outcome measures
| Measure |
Paromomycin Alone Treatment
n=16 Participants
Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
|
WR 279,396
n=14 Participants
WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
|
|---|---|---|
|
Final Clinical Cure for Index Lesions
|
11 participants
|
9 participants
|
SECONDARY outcome
Timeframe: Day 4, 7, 12, 17, 20, 28Population: Adults (18+ years)
Paromomycin plasma concentrations following administration of paromomycin alone or WR 279,396 in adults
Outcome measures
| Measure |
Paromomycin Alone Treatment
n=5 Participants
Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
|
WR 279,396
n=4 Participants
WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
|
|---|---|---|
|
Detectable Paromomycin Plasma Levels
Day 4
|
12.1 ng/mL
Standard Deviation 27.0
|
37.3 ng/mL
Standard Deviation 74.5
|
|
Detectable Paromomycin Plasma Levels
Day 7
|
10.3 ng/mL
Standard Deviation 23.1
|
17.9 ng/mL
Standard Deviation 35.8
|
|
Detectable Paromomycin Plasma Levels
Day 12
|
36.2 ng/mL
Standard Deviation 33.2
|
78.9 ng/mL
Standard Deviation 81.6
|
|
Detectable Paromomycin Plasma Levels
Day 17
|
210.0 ng/mL
Standard Deviation 327.0
|
162.0 ng/mL
Standard Deviation 123.0
|
|
Detectable Paromomycin Plasma Levels
Day 20
|
87.3 ng/mL
Standard Deviation 109.0
|
128.0 ng/mL
Standard Deviation 58.7
|
|
Detectable Paromomycin Plasma Levels
Day 28
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 0 and 4 hours on days 1 and 20Population: Children ages 5 to 17 (inclusive)
Paromomycin plasma concentrations 4 hours following administration of paromomycin alone or WR 279,396 in children
Outcome measures
| Measure |
Paromomycin Alone Treatment
n=11 Participants
Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
|
WR 279,396
n=10 Participants
WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
|
|---|---|---|
|
Paromomycin Plasma Concentrations in Children
Day 1 hour 0
|
6.2 ng/mL
Standard Deviation 20.5
|
22.1 ng/mL
Standard Deviation 69.9
|
|
Paromomycin Plasma Concentrations in Children
Day 1 hour 4
|
71.2 ng/mL
Standard Deviation 88.0
|
322.0 ng/mL
Standard Deviation 757.0
|
|
Paromomycin Plasma Concentrations in Children
Day 20 hour 0
|
93.8 ng/mL
Standard Deviation 59.9
|
89.2 ng/mL
Standard Deviation 132.0
|
|
Paromomycin Plasma Concentrations in Children
Day 20 hour 4
|
744.0 ng/mL
Standard Deviation 503.0
|
1030.0 ng/mL
Standard Deviation 1460.0
|
SECONDARY outcome
Timeframe: 0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20Population: Adults (18+ years)
Cmax of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama
Outcome measures
| Measure |
Paromomycin Alone Treatment
n=5 Participants
Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
|
WR 279,396
n=4 Participants
WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
|
|---|---|---|
|
Pharmacokinetic Parameter: Cmax
Day 1
|
511 ng/mL
Standard Deviation 445
|
155.0 ng/mL
Standard Deviation 139.0
|
|
Pharmacokinetic Parameter: Cmax
Day 20
|
1400 ng/mL
Standard Deviation 842
|
882 ng/mL
Standard Deviation 124
|
SECONDARY outcome
Timeframe: 0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20Population: Adults (18+ years). On day 1, Paromomycin Alone Treatment group N = 4; WR 279,396 group N = 3.
Pharmacokinetic Parameter: Tmax
Outcome measures
| Measure |
Paromomycin Alone Treatment
n=5 Participants
Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
|
WR 279,396
n=4 Participants
WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
|
|---|---|---|
|
Pharmacokinetic Parameter: Tmax
Day 1
|
2.25 hr
Standard Deviation 0.5
|
3 hr
Standard Deviation 1.73
|
|
Pharmacokinetic Parameter: Tmax
Day 20
|
4.6 hr
Standard Deviation 3.13
|
3 hr
Standard Deviation 1.15
|
SECONDARY outcome
Timeframe: 0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20Population: Adults (18+ years)
Area under the curve (AUC) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama
Outcome measures
| Measure |
Paromomycin Alone Treatment
n=5 Participants
Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
|
WR 279,396
n=4 Participants
WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
|
|---|---|---|
|
Pharmacokinetic Parameter: Area Under the Curve (AUC)
Day 1
|
3154 ng*hr/mL
Standard Deviation 3562
|
1228 ng*hr/mL
Standard Deviation 1413
|
|
Pharmacokinetic Parameter: Area Under the Curve (AUC)
Day 20
|
13331 ng*hr/mL
Standard Deviation 9156
|
8955 ng*hr/mL
Standard Deviation 1955
|
SECONDARY outcome
Timeframe: 0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20Population: Adults (18+ years). WR 279,396 group measurements Day 1 N = 2 and Day 20 N = 4. One study participant in the Paromomycin Alone Treatment was withdrawn at Day 100.
t(1/2) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama
Outcome measures
| Measure |
Paromomycin Alone Treatment
n=4 Participants
Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
|
WR 279,396
n=4 Participants
WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
|
|---|---|---|
|
Pharmacokinetic Parameter: t(1/2)
Day 1
|
2.55 hr
Standard Deviation 1.23
|
4.51 hr
Standard Deviation 0.06
|
|
Pharmacokinetic Parameter: t(1/2)
Day 20
|
7.17 hr
Standard Deviation 3.29
|
6.81 hr
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: 0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20Population: Adults (18+ years)
Maximum observed plasma concentration divide by topical dose (Cmax/D) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama
Outcome measures
| Measure |
Paromomycin Alone Treatment
n=5 Participants
Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
|
WR 279,396
n=4 Participants
WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
|
|---|---|---|
|
Pharmacokinetic Parameter: Cmax/D
Day 1
|
185 1/ML
Standard Deviation 144
|
45.9 1/ML
Standard Deviation 35.8
|
|
Pharmacokinetic Parameter: Cmax/D
Day 20
|
368 1/ML
Standard Deviation 196
|
283 1/ML
Standard Deviation 118
|
SECONDARY outcome
Timeframe: Days 1 and 20Population: Adults (18+ years)
Area under the plasma concentration-time curve over 24 hrs divided by topical dose (AUC/D) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama
Outcome measures
| Measure |
Paromomycin Alone Treatment
n=5 Participants
Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
|
WR 279,396
n=4 Participants
WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
|
|---|---|---|
|
Pharmacokinetic Parameter: AUC/D
Day 1
|
996.7 hr/ML
Standard Deviation 976.1
|
340.5 hr/ML
Standard Deviation 368.9
|
|
Pharmacokinetic Parameter: AUC/D
Day 20
|
3335 hr/ML
Standard Deviation 1482
|
3155 hr/ML
Standard Deviation 2151
|
SECONDARY outcome
Timeframe: Initial clinical cure by day 63 and no relapse by day 168Final clinical cure was defined as follows: 1. Subject has initial clinical cure (100% re-epithelialization of lesion by nominal Day 63); OR, 2. Subject has initial clinical improvement (\> 50% re-epithelialization of lesion by nominal Day 63 followed by 100% re-epithelialization of the lesion on or before nominal Day 100; AND, 3. Subject has no relapse of lesion by Day 168. Relapse was defined as a lesion meeting the criteria for initial clinical cure that had any new ulceration/nodule (\> 0 x 0 mm measurement) by nominal day 168, or a lesion meeting the criteria for initial clinical improvement that subsequently enlarged by nominal Day 168.
Outcome measures
| Measure |
Paromomycin Alone Treatment
n=22 Total number of ulerated lesions
Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
|
WR 279,396
n=21 Total number of ulerated lesions
WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
|
|---|---|---|
|
Final Clinical Cure on All Lesions Independent of Subjects
|
12 Cured ulcerated lesions
|
14 Cured ulcerated lesions
|
SECONDARY outcome
Timeframe: Day 1, 4, 7, 12, 17, 20, 28, 35, 42, 49, 56, 63, 100, 168Number of study participants who meet the criteria for clinical cure (100% re-epithelialization) at specified timepoints during the study.
Outcome measures
| Measure |
Paromomycin Alone Treatment
n=16 Participants
Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
|
WR 279,396
n=14 Participants
WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
|
|---|---|---|
|
Number of Index Lesions Meeting Criteria for Clinical Cure During the Study
Day 1
|
0 Lesions meeting clinical cure criteria
|
0 Lesions meeting clinical cure criteria
|
|
Number of Index Lesions Meeting Criteria for Clinical Cure During the Study
Day 4
|
0 Lesions meeting clinical cure criteria
|
0 Lesions meeting clinical cure criteria
|
|
Number of Index Lesions Meeting Criteria for Clinical Cure During the Study
Day 7
|
0 Lesions meeting clinical cure criteria
|
0 Lesions meeting clinical cure criteria
|
|
Number of Index Lesions Meeting Criteria for Clinical Cure During the Study
Day 12
|
0 Lesions meeting clinical cure criteria
|
0 Lesions meeting clinical cure criteria
|
|
Number of Index Lesions Meeting Criteria for Clinical Cure During the Study
Day 17
|
0 Lesions meeting clinical cure criteria
|
0 Lesions meeting clinical cure criteria
|
|
Number of Index Lesions Meeting Criteria for Clinical Cure During the Study
Day 20
|
1 Lesions meeting clinical cure criteria
|
0 Lesions meeting clinical cure criteria
|
|
Number of Index Lesions Meeting Criteria for Clinical Cure During the Study
Day 28
|
5 Lesions meeting clinical cure criteria
|
6 Lesions meeting clinical cure criteria
|
|
Number of Index Lesions Meeting Criteria for Clinical Cure During the Study
Day 35
|
8 Lesions meeting clinical cure criteria
|
11 Lesions meeting clinical cure criteria
|
|
Number of Index Lesions Meeting Criteria for Clinical Cure During the Study
Day 42
|
10 Lesions meeting clinical cure criteria
|
11 Lesions meeting clinical cure criteria
|
|
Number of Index Lesions Meeting Criteria for Clinical Cure During the Study
Day 49
|
10 Lesions meeting clinical cure criteria
|
12 Lesions meeting clinical cure criteria
|
|
Number of Index Lesions Meeting Criteria for Clinical Cure During the Study
Day 56
|
11 Lesions meeting clinical cure criteria
|
10 Lesions meeting clinical cure criteria
|
|
Number of Index Lesions Meeting Criteria for Clinical Cure During the Study
Day 63
|
11 Lesions meeting clinical cure criteria
|
10 Lesions meeting clinical cure criteria
|
|
Number of Index Lesions Meeting Criteria for Clinical Cure During the Study
Day 100
|
12 Lesions meeting clinical cure criteria
|
10 Lesions meeting clinical cure criteria
|
|
Number of Index Lesions Meeting Criteria for Clinical Cure During the Study
Day 168
|
11 Lesions meeting clinical cure criteria
|
9 Lesions meeting clinical cure criteria
|
Adverse Events
Paromomycin Alone Treatment
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
WR 279,396
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Paromomycin Alone Treatment
n=16 participants at risk
Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
|
WR 279,396
n=14 participants at risk
WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/16
|
7.1%
1/14
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
18.8%
3/16
|
14.3%
2/14
|
|
Ear and labyrinth disorders
Motion sickness
|
0.00%
0/16
|
7.1%
1/14
|
|
Endocrine disorders
Bleeding anovulatory
|
0.00%
0/16
|
7.1%
1/14
|
|
Eye disorders
Conjunctivitis allergic
|
6.2%
1/16
|
7.1%
1/14
|
|
Eye disorders
Myopia
|
0.00%
0/16
|
7.1%
1/14
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/16
|
14.3%
2/14
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/16
|
7.1%
1/14
|
|
General disorders
Application site bleeding
|
12.5%
2/16
|
14.3%
2/14
|
|
General disorders
Application site erythema
|
75.0%
12/16
|
64.3%
9/14
|
|
General disorders
Application site induration
|
12.5%
2/16
|
7.1%
1/14
|
|
General disorders
Application site oedema
|
37.5%
6/16
|
35.7%
5/14
|
|
General disorders
Application site pain
|
81.2%
13/16
|
21.4%
3/14
|
|
General disorders
Application site papules
|
6.2%
1/16
|
7.1%
1/14
|
|
General disorders
Application site pruritus
|
100.0%
16/16
|
100.0%
14/14
|
|
General disorders
Application site vesicles
|
12.5%
2/16
|
42.9%
6/14
|
|
General disorders
Injection site extravasation
|
0.00%
0/16
|
7.1%
1/14
|
|
General disorders
Oedema
|
0.00%
0/16
|
7.1%
1/14
|
|
Immune system disorders
Hypersensitivity
|
75.0%
12/16
|
78.6%
11/14
|
|
Infections and infestations
Application site cellulitis
|
0.00%
0/16
|
7.1%
1/14
|
|
Infections and infestations
Cutaneous leishmaniasis relapse
|
12.5%
2/16
|
21.4%
3/14
|
|
Infections and infestations
Gastroenteritis
|
6.2%
1/16
|
7.1%
1/14
|
|
Infections and infestations
Influenza
|
6.2%
1/16
|
21.4%
3/14
|
|
Infections and infestations
Nasopharyngitis
|
6.2%
1/16
|
28.6%
4/14
|
|
Infections and infestations
Oral herpes
|
0.00%
0/16
|
7.1%
1/14
|
|
Infections and infestations
Otitis media
|
0.00%
0/16
|
7.1%
1/14
|
|
Infections and infestations
Superinfection bacterial
|
18.8%
3/16
|
14.3%
2/14
|
|
Infections and infestations
Tooth infection
|
0.00%
0/16
|
7.1%
1/14
|
|
Infections and infestations
Upper respiratory tract infection
|
75.0%
12/16
|
64.3%
9/14
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/16
|
7.1%
1/14
|
|
Injury, poisoning and procedural complications
Skin injury
|
6.2%
1/16
|
7.1%
1/14
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/16
|
7.1%
1/14
|
|
Investigations
Headache
|
37.5%
6/16
|
28.6%
4/14
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
2/16
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/16
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/16
|
14.3%
2/14
|
|
Skin and subcutaneous tissue disorders
Burning sensation
|
0.00%
0/16
|
14.3%
2/14
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
12.5%
2/16
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/16
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/16
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/16
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
6.2%
1/16
|
0.00%
0/14
|
|
Vascular disorders
Lymphoedema
|
6.2%
1/16
|
7.1%
1/14
|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.5%
2/16
|
0.00%
0/14
|
|
General disorders
Vessel puncture site pain
|
6.2%
1/16
|
0.00%
0/14
|
|
Infections and infestations
Cutaneous leishmaniasis
|
6.2%
1/16
|
0.00%
0/14
|
|
Infections and infestations
Pneumonia
|
6.2%
1/16
|
0.00%
0/14
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
6.2%
1/16
|
0.00%
0/14
|
|
Nervous system disorders
Hypoaesthesia
|
12.5%
2/16
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
6.2%
1/16
|
0.00%
0/14
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.2%
1/16
|
0.00%
0/14
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
6.2%
1/16
|
0.00%
0/14
|
Additional Information
Director, Division of Regulated Activites and Compliance
US Army Medical Materiel Development Activity (USAMMDA)
Phone: 301-619-0197
Results disclosure agreements
- Principal investigator is a sponsor employee Parties agree to keep Referenced Information in strict confidence and not to disclose it to any other party or use Referenced Information for any purpose, other than for the performance of the clinical studies herein described, without prior written consent of the providing party. Parties may disclose the Referenced Information to their employees and consultants, and employees and consultants of their affiliates, who have a need to know such Referenced Information.
- Publication restrictions are in place
Restriction type: OTHER