Trial Outcomes & Findings for Study of the Effects of Brilacidin Oral Rinse on Radiation-induced Oral Mucositis in Patients With Head and Neck Cancer (NCT NCT02324335)
NCT ID: NCT02324335
Last Updated: 2019-01-16
Results Overview
Incidence of severe oral mucositis, defined as grade 3 or 4 on the WHO Oral Mucositis score, experienced during radiation therapy by patients with head and neck cancer receiving a cumulative radiation dose of at least 55 Gy. The higher the score the more severe the mucositis.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
61 participants
Primary outcome timeframe
7 weeks
Results posted on
2019-01-16
Participant Flow
61 subjects were randomized, and 59 subjects received study drug; 59 subjects were analyzed for safety, and 46 subjects were analyzed for efficacy.
Participant milestones
| Measure |
Placebo Oral Rinse
Water for Injection
Placebo: Oral Rinse used 3 times daily for 7 weeks
|
Active Oral Rinse
Brilacidin 3 mg/mL in Water for Injection
Brilacidin: Oral Rinse used 3 times daily for 7 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
29
|
|
Overall Study
COMPLETED
|
21
|
20
|
|
Overall Study
NOT COMPLETED
|
9
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of the Effects of Brilacidin Oral Rinse on Radiation-induced Oral Mucositis in Patients With Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Placebo Oral Rinse
n=30 Participants
Water for Injection
Placebo: Oral Rinse used 3 times daily for 7 weeks
|
Active Oral Rinse
n=29 Participants
Brilacidin 3 mg/mL in Water for Injection
Brilacidin: Oral Rinse used 3 times daily for 7 weeks
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.3 years
STANDARD_DEVIATION 8.63 • n=5 Participants
|
60.3 years
STANDARD_DEVIATION 9.05 • n=7 Participants
|
58.8 years
STANDARD_DEVIATION 8.88 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
29 participants
n=7 Participants
|
59 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 weeksPopulation: mITT Population included all randomized subjects who received at least one dose of study drug and a cumulative radiation dose of at least 55 Gy (and no more than 72 Gy)
Incidence of severe oral mucositis, defined as grade 3 or 4 on the WHO Oral Mucositis score, experienced during radiation therapy by patients with head and neck cancer receiving a cumulative radiation dose of at least 55 Gy. The higher the score the more severe the mucositis.
Outcome measures
| Measure |
Placebo Oral Rinse
n=25 Participants
Water for Injection
Placebo: Oral Rinse used 3 times daily for 7 weeks
|
Active Oral Rinse
n=21 Participants
Brilacidin 3 mg/mL in Water for Injection
Brilacidin: Oral Rinse used 3 times daily for 7 weeks
|
|---|---|---|
|
Incidence of Severe OM During Radiation Therapy in Subjects Receiving a Cumulative IMRT Dose of at Least 55 Gy
Severe OM Yes
|
15 Participants
|
9 Participants
|
|
Incidence of Severe OM During Radiation Therapy in Subjects Receiving a Cumulative IMRT Dose of at Least 55 Gy
Severe OM NO
|
10 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 11 weeksOverall duration of severe OM was defined as the number of days from initial WHO Grade ≥3 during radiation therapy to the day prior to the next OM assessment after the last WHO Grade ≥3 during/after radiation therapy.
Outcome measures
| Measure |
Placebo Oral Rinse
n=25 Participants
Water for Injection
Placebo: Oral Rinse used 3 times daily for 7 weeks
|
Active Oral Rinse
n=21 Participants
Brilacidin 3 mg/mL in Water for Injection
Brilacidin: Oral Rinse used 3 times daily for 7 weeks
|
|---|---|---|
|
Duration of Severe Oral Mucositis (WHO Grade ≥3) [Overall Duration]
|
3.0 Days
Interval 0.0 to 52.0
|
0.0 Days
Interval 0.0 to 53.0
|
SECONDARY outcome
Timeframe: 7 weeksPopulation: Subgroup of subjects receiving cisplatin every 21 days
Incidence of severe oral mucositis (WHO Grade ≥3) for subjects receiving cisplatin every 21 days
Outcome measures
| Measure |
Placebo Oral Rinse
n=14 Participants
Water for Injection
Placebo: Oral Rinse used 3 times daily for 7 weeks
|
Active Oral Rinse
n=8 Participants
Brilacidin 3 mg/mL in Water for Injection
Brilacidin: Oral Rinse used 3 times daily for 7 weeks
|
|---|---|---|
|
Incidence of Severe Oral Mucositis (WHO Grade ≥3) for Subjects Receiving Cisplatin Every 21 Days
Severe OM NO
|
4 Participants
|
6 Participants
|
|
Incidence of Severe Oral Mucositis (WHO Grade ≥3) for Subjects Receiving Cisplatin Every 21 Days
Severe OM Yes
|
10 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 7 weeksPopulation: Data is presented for all subjects (censored and uncensored) in the mITT population, with a censored outcome reported as "NA".
Time to onset of severe oral mucositis (WHO Grade ≥3) analyzed using Kaplan-Meier methods.
Outcome measures
| Measure |
Placebo Oral Rinse
n=25 Participants
Water for Injection
Placebo: Oral Rinse used 3 times daily for 7 weeks
|
Active Oral Rinse
n=21 Participants
Brilacidin 3 mg/mL in Water for Injection
Brilacidin: Oral Rinse used 3 times daily for 7 weeks
|
|---|---|---|
|
Time to Onset of Severe Oral Mucositis (WHO Grade ≥3)
|
47 days
Interval 19.0 to
Max \[censored\] 50 days
|
NA days
Interval 15.0 to
Max \[censored\] 49 days
|
Adverse Events
Placebo Oral Rinse
Serious events: 5 serious events
Other events: 30 other events
Deaths: 0 deaths
Active Oral Rinse
Serious events: 8 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Oral Rinse
n=30 participants at risk
Water for Injection
Placebo: Oral Rinse used 3 times daily for 7 weeks
|
Active Oral Rinse
n=29 participants at risk
Brilacidin 3 mg/mL in Water for Injection
Brilacidin: Oral Rinse used 3 times daily for 7 weeks
|
|---|---|---|
|
Metabolism and nutrition disorders
Hypophagia
|
3.3%
1/30 • Number of events 1 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
0.00%
0/29 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
|
Gastrointestinal disorders
Nausea
|
3.3%
1/30 • Number of events 1 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
6.9%
2/29 • Number of events 2 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
|
Gastrointestinal disorders
Vomiting
|
3.3%
1/30 • Number of events 1 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
0.00%
0/29 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
|
Gastrointestinal disorders
Oral pain
|
3.3%
1/30 • Number of events 1 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
0.00%
0/29 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
3.3%
1/30 • Number of events 1 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
0.00%
0/29 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
|
Vascular disorders
Venous thrombosis
|
3.3%
1/30 • Number of events 1 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
0.00%
0/29 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
|
Metabolism and nutrition disorders
Dehydration
|
3.3%
1/30 • Number of events 1 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
3.4%
1/29 • Number of events 1 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.3%
1/30 • Number of events 1 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
0.00%
0/29 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/30 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
3.4%
1/29 • Number of events 1 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/30 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
3.4%
1/29 • Number of events 1 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/30 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
3.4%
1/29 • Number of events 1 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/30 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
3.4%
1/29 • Number of events 1 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
|
Infections and infestations
Skin infection
|
0.00%
0/30 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
3.4%
1/29 • Number of events 1 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
|
Vascular disorders
Embolism
|
0.00%
0/30 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
3.4%
1/29 • Number of events 1 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/30 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
3.4%
1/29 • Number of events 1 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
|
Infections and infestations
Device related infection
|
0.00%
0/30 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
3.4%
1/29 • Number of events 1 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
|
Infections and infestations
Catheter site cellulitis
|
0.00%
0/30 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
3.4%
1/29 • Number of events 1 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/30 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
3.4%
1/29 • Number of events 1 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
Other adverse events
| Measure |
Placebo Oral Rinse
n=30 participants at risk
Water for Injection
Placebo: Oral Rinse used 3 times daily for 7 weeks
|
Active Oral Rinse
n=29 participants at risk
Brilacidin 3 mg/mL in Water for Injection
Brilacidin: Oral Rinse used 3 times daily for 7 weeks
|
|---|---|---|
|
General disorders
Fatigue
|
43.3%
13/30 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
72.4%
21/29 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
|
Nervous system disorders
Dysgeusia
|
43.3%
13/30 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
58.6%
17/29 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
|
Gastrointestinal disorders
Dry mouth
|
30.0%
9/30 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
55.2%
16/29 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
|
Gastrointestinal disorders
Constipation
|
56.7%
17/30 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
44.8%
13/29 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
|
Gastrointestinal disorders
Oral pain
|
13.3%
4/30 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
24.1%
7/29 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
|
Gastrointestinal disorders
Saliva altered
|
13.3%
4/30 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
24.1%
7/29 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
|
Investigations
Blood creatinine increased
|
10.0%
3/30 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
24.1%
7/29 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
|
Investigations
White blood cell count decreased
|
36.7%
11/30 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
20.7%
6/29 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
10.0%
3/30 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
20.7%
6/29 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
|
Nervous system disorders
Headache
|
6.7%
2/30 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
20.7%
6/29 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
|
Investigations
Blood urea increased
|
3.3%
1/30 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
20.7%
6/29 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
36.7%
11/30 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
17.2%
5/29 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
|
Nervous system disorders
Dizziness
|
3.3%
1/30 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
17.2%
5/29 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.7%
2/30 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
0.00%
0/29 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
23.3%
7/30 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
13.8%
4/29 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
|
Psychiatric disorders
Anxiety
|
20.0%
6/30 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
3.4%
1/29 • AEs were recorded from the time a subject signs the ICF through the End of Study visit (or Early Withdrawal visit for subjects who withdraw or are withdrawn from the study). This could be up to 17 weeks
Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,
|
Additional Information
Arthur P. Bertolino MD, PhD, MBA
Innovation Pharmaceuticals Inc.
Phone: 978.921.4125
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60