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Efficacy, Safety and Tolerability of AG013 in Oral Mucositis Compared to Placebo When Administered Three Times Per Day

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03234465
Recruitment Status : Terminated (No efficacy could be demonstrated, sponsor decided to prematurely end the study.)
First Posted : July 31, 2017
Results First Posted : November 23, 2020
Last Update Posted : November 23, 2020
Sponsor:
Information provided by (Responsible Party):
Oragenics, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Oral Mucositis
Interventions Biological: AG013
Other: Placebo
Enrollment 200
Recruitment Details  
Pre-assignment Details 3 patients were randomized but never received study drug and are excluded from the safety analysis set.
Arm/Group Title AG013 Placebo
Hide Arm/Group Description Three rinses per day with AG013 mouth rinse beginning from the start of radiotherapy until 2 weeks following its completion for 7 to 9 weeks, depending on the duration of radiotherapy. Three rinses per day with placebo mouth rinse beginning from the start of radiotherapy until 2 weeks following its completion for 7 to 9 weeks, depending on the duration of radiotherapy.
Period Title: Overall Study
Started 100 100
Completed 67 60
Not Completed 33 40
Reason Not Completed
Adverse Event             4             2
Death             0             1
Lost to Follow-up             1             1
Withdrawal by Subject             12             27
Symptomatic deterioration             0             1
Non-compliance             2             0
Other             14             8
Arm/Group Title AG013 Placebo Total
Hide Arm/Group Description Three rinses per day with AG013 mouth rinse beginning from the start of radiotherapy until 2 weeks following its completion for 7 to 9 weeks, depending on the duration of radiotherapy. Three rinses per day with placebo mouth rinse beginning from the start of radiotherapy until 2 weeks following its completion for 7 to 9 weeks, depending on the duration of radiotherapy. Total of all reporting groups
Overall Number of Baseline Participants 100 100 200
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants 100 participants 200 participants
60.4  (9.98) 60.4  (9.10) 60.4  (9.53)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 100 participants 200 participants
Female
19
  19.0%
16
  16.0%
35
  17.5%
Male
81
  81.0%
84
  84.0%
165
  82.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 100 participants 200 participants
Hispanic or Latino
2
   2.0%
7
   7.0%
9
   4.5%
Not Hispanic or Latino
91
  91.0%
81
  81.0%
172
  86.0%
Unknown or Not Reported
7
   7.0%
12
  12.0%
19
   9.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 100 participants 200 participants
American Indian or Alaska Native
0
   0.0%
1
   1.0%
1
   0.5%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
1
   1.0%
0
   0.0%
1
   0.5%
Black or African American
4
   4.0%
3
   3.0%
7
   3.5%
White
93
  93.0%
92
  92.0%
185
  92.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   2.0%
4
   4.0%
6
   3.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 100 participants 100 participants 200 participants
United States 65 65 130
Europe 35 35 70
1.Primary Outcome
Title Efficacy of AG013 Compared to Placebo for Reducing OM as Measured by Duration (in Days) of Severe Oral Mucositis (WHO Grades 3 or 4)
Hide Description Duration (in Days) of Severe Oral Mucositis (WHO Grades 3 or 4)
Time Frame From the start of radiation therapy (RT) until 2 weeks following its completion, 7 to 9 weeks depending on the duration of CRT.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AG013 Placebo
Hide Arm/Group Description:
Three rinses per day with AG013 mouth rinse beginning from the start of radiotherapy until 2 weeks following its completion for 7 to 9 weeks, depending on the duration of radiotherapy.
Three rinses per day with placebo mouth rinse beginning from the start of radiotherapy until 2 weeks following its completion for 7 to 9 weeks, depending on the duration of radiotherapy.
Overall Number of Participants Analyzed 100 100
Mean (Standard Deviation)
Unit of Measure: Days
US 19.6  (25.00) 20.6  (25.20)
Europe 17.2  (22.67) 15.3  (22.54)
Time Frame From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT.
Adverse Event Reporting Description

Safety analyses were performed on the Safety Population which is comprised of all patients randomized to treatment and who received at least one dose of study drug.

3 patients were randomized but never received study drug and are excluded from these analyses.

 
Arm/Group Title AG013 Placebo
Hide Arm/Group Description Three rinses per day with AG013 mouth rinse beginning from the start of radiotherapy until 2 weeks following its completion for 7 to 9 weeks, depending on the duration of radiotherapy. Three rinses per day with placebo mouth rinse beginning from the start of radiotherapy until 2 weeks following its completion for 7 to 9 weeks, depending on the duration of radiotherapy.
All-Cause Mortality
AG013 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   2/100 (2.00%)   4/97 (4.12%) 
Hide Serious Adverse Events
AG013 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   43/100 (43.00%)   25/97 (25.77%) 
Blood and lymphatic system disorders     
Febrile neutropenia *  1/100 (1.00%)  2/97 (2.06%) 
Anaemia *  1/100 (1.00%)  0/97 (0.00%) 
Leukopenia *  0/100 (0.00%)  1/97 (1.03%) 
Pancytopenia *  0/100 (0.00%)  1/97 (1.03%) 
Cardiac disorders     
Acute myocardial infarction *  1/100 (1.00%)  0/97 (0.00%) 
Cardio-respiratory arrest *  0/100 (0.00%)  1/97 (1.03%) 
Gastrointestinal disorders     
Nausea *  7/100 (7.00%)  5/97 (5.15%) 
Vomiting *  6/100 (6.00%)  4/97 (4.12%) 
Dysphagia *  6/100 (6.00%)  3/97 (3.09%) 
Diarrhoea *  0/100 (0.00%)  1/97 (1.03%) 
Gastric haemorrhage *  1/100 (1.00%)  0/97 (0.00%) 
Gastrooesophageal reflux disease *  1/100 (1.00%)  0/97 (0.00%) 
Inguinal hernia *  1/100 (1.00%)  0/97 (0.00%) 
Neutropenic colitis *  0/100 (0.00%)  1/97 (1.03%) 
Odynophagia *  0/100 (0.00%)  1/97 (1.03%) 
General disorders     
Pyrexia *  3/100 (3.00%)  4/97 (4.12%) 
General physical health deterioriation *  2/100 (2.00%)  1/97 (1.03%) 
Asthenia *  1/100 (1.00%)  1/97 (1.03%) 
Pain *  1/100 (1.00%)  1/97 (1.03%) 
Administration site extravasation *  1/100 (1.00%)  0/97 (0.00%) 
Catheter site pain *  1/100 (1.00%)  0/97 (0.00%) 
Fatigue *  1/100 (1.00%)  0/97 (0.00%) 
Hepatobiliary disorders     
Hepatic failure *  0/100 (0.00%)  1/97 (1.03%) 
Infections and infestations     
Pneumonia *  3/100 (3.00%)  1/97 (1.03%) 
Bronchitis *  2/100 (2.00%)  0/97 (0.00%) 
Candida infection *  0/100 (0.00%)  1/97 (1.03%) 
Cellulitis *  0/100 (0.00%)  1/97 (1.03%) 
Clostridium difficile colitis *  0/100 (0.00%)  1/97 (1.03%) 
Diverticulitis *  1/100 (1.00%)  0/97 (0.00%) 
Infection *  0/100 (0.00%)  1/97 (1.03%) 
Lower respiratory tract infection *  1/100 (1.00%)  0/97 (0.00%) 
Lung infection *  1/100 (1.00%)  0/97 (0.00%) 
Pharyngitis *  1/100 (1.00%)  0/97 (0.00%) 
Sepsis *  1/100 (1.00%)  0/97 (0.00%) 
Septic shock *  0/100 (0.00%)  1/97 (1.03%) 
Tracheobronchitis *  1/100 (1.00%)  0/97 (0.00%) 
Tracheostomy infection *  1/100 (1.00%)  0/97 (0.00%) 
Injury, poisoning and procedural complications     
Gastrointestinal anastomotic leak *  0/100 (0.00%)  1/97 (1.03%) 
Radiation skin injury *  0/100 (0.00%)  1/97 (1.03%) 
Investigations     
Alanine aminotransferase increased *  1/100 (1.00%)  0/97 (0.00%) 
Aspartate aminotransferase increased *  1/100 (1.00%)  0/97 (0.00%) 
Blood creatinine increased *  1/100 (1.00%)  0/97 (0.00%) 
Troponin increased *  0/100 (0.00%)  1/97 (1.03%) 
Metabolism and nutrition disorders     
Dehydration *  1/100 (1.00%)  3/97 (3.09%) 
Decreased appetite *  2/100 (2.00%)  0/97 (0.00%) 
Failure to thrive *  2/100 (2.00%)  0/97 (0.00%) 
Hypokalaemia *  1/100 (1.00%)  0/97 (0.00%) 
Hyponatraemia *  1/100 (1.00%)  0/97 (0.00%) 
Hypophagia *  0/100 (0.00%)  1/97 (1.03%) 
Malnutrition *  1/100 (1.00%)  0/97 (0.00%) 
Musculoskeletal and connective tissue disorders     
Neck pain *  1/100 (1.00%)  0/97 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Hairy cell leukaemia *  1/100 (1.00%)  0/97 (0.00%) 
Nervous system disorders     
Epilepsy *  1/100 (1.00%)  0/97 (0.00%) 
Psychiatric disorders     
Suicidal ideation *  0/100 (0.00%)  2/97 (2.06%) 
Anxiety *  0/100 (0.00%)  1/97 (1.03%) 
Psychiatric decompensation *  1/100 (1.00%)  0/97 (0.00%) 
Renal and urinary disorders     
Acute kidney injury *  5/100 (5.00%)  2/97 (2.06%) 
Renal failure *  0/100 (0.00%)  1/97 (1.03%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism *  2/100 (2.00%)  1/97 (1.03%) 
Oropharynggeal pain *  2/100 (2.00%)  0/97 (0.00%) 
Acute pulmonary oedema *  1/100 (1.00%)  0/97 (0.00%) 
Acute respiratory failure *  1/100 (1.00%)  0/97 (0.00%) 
Pneumonia aspiratoin *  1/100 (1.00%)  0/97 (0.00%) 
Vascular disorders     
Hypotension *  1/100 (1.00%)  1/97 (1.03%) 
Circulatory collapse *  1/100 (1.00%)  0/97 (0.00%) 
Deep vein thrombosis *  1/100 (1.00%)  0/97 (0.00%) 
Thrombosis *  1/100 (1.00%)  0/97 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AG013 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   98/100 (98.00%)   95/97 (97.94%) 
Blood and lymphatic system disorders     
Anaemia *  21/100 (21.00%)  33/97 (34.02%) 
Leukopenia *  12/100 (12.00%)  11/97 (11.34%) 
Thrombocytopenia *  7/100 (7.00%)  6/97 (6.19%) 
Neutropenia *  9/100 (9.00%)  2/97 (2.06%) 
Lymphopenia *  1/100 (1.00%)  6/97 (6.19%) 
Ear and labyrinth disorders     
Tinnitus *  20/100 (20.00%)  18/97 (18.56%) 
Ear pain *  6/100 (6.00%)  4/97 (4.12%) 
Gastrointestinal disorders     
Nausea *  67/100 (67.00%)  69/97 (71.13%) 
Constipation *  54/100 (54.00%)  41/97 (42.27%) 
Dry mouth *  39/100 (39.00%)  42/97 (43.30%) 
Vomiting *  38/100 (38.00%)  38/97 (39.18%) 
Dysphagia *  33/100 (33.00%)  39/97 (40.21%) 
Diarrhoea *  27/100 (27.00%)  43/97 (44.33%) 
Oral pain *  17/100 (17.00%)  14/97 (14.43%) 
Dyspepsia *  15/100 (15.00%)  12/97 (12.37%) 
Gastrooesophageal reflux disease *  13/100 (13.00%)  5/97 (5.15%) 
Odynophagia *  7/100 (7.00%)  9/97 (9.28%) 
Saliva altered *  8/100 (8.00%)  4/97 (4.12%) 
General disorders     
Fatigue *  56/100 (56.00%)  58/97 (59.79%) 
Pyrexia *  14/100 (14.00%)  9/97 (9.28%) 
Secretion discharge *  13/100 (13.00%)  8/97 (8.25%) 
Asthenia *  5/100 (5.00%)  4/97 (4.12%) 
Pain *  5/100 (5.00%)  4/97 (4.12%) 
Localised oedema *  5/100 (5.00%)  0/97 (0.00%) 
Infections and infestations     
Candida infection *  17/100 (17.00%)  13/97 (13.40%) 
Oral candidiasis *  20/100 (20.00%)  6/97 (6.19%) 
Mucosal infection *  6/100 (6.00%)  8/97 (8.25%) 
Injury, poisoning and procedural complications     
Radiation skin injury *  32/100 (32.00%)  45/97 (46.39%) 
Gastrostomy tube site complication *  2/100 (2.00%)  5/97 (5.15%) 
Investigations     
Weight decreased *  29/100 (29.00%)  29/97 (29.90%) 
White blood cell count decreased *  12/100 (12.00%)  15/97 (15.46%) 
Blood creatinine increased *  14/100 (14.00%)  10/97 (10.31%) 
Platelet count decreased *  10/100 (10.00%)  12/97 (12.37%) 
Neutrophil count decreased *  11/100 (11.00%)  10/97 (10.31%) 
Lymphocyte count decreased *  5/100 (5.00%)  7/97 (7.22%) 
Alanine aminotransferase increased *  4/100 (4.00%)  6/97 (6.19%) 
Blood urea increased *  4/100 (4.00%)  6/97 (6.19%) 
Metabolism and nutrition disorders     
Decreased appetite *  27/100 (27.00%)  25/97 (25.77%) 
Dehydration *  19/100 (19.00%)  20/97 (20.62%) 
Hypokalaemia *  12/100 (12.00%)  7/97 (7.22%) 
Hypomagnesaemia *  8/100 (8.00%)  9/97 (9.28%) 
Hyponatraemia *  6/100 (6.00%)  11/97 (11.34%) 
Hyperglycaemia *  5/100 (5.00%)  10/97 (10.31%) 
Malnutrition *  7/100 (7.00%)  0/97 (0.00%) 
Hyperkalaemia *  1/100 (1.00%)  5/97 (5.15%) 
Hypocalcaemia *  0/100 (0.00%)  5/97 (5.15%) 
Musculoskeletal and connective tissue disorders     
Neck pain *  7/100 (7.00%)  5/97 (5.15%) 
Nervous system disorders     
Dysgeusia *  43/100 (43.00%)  49/97 (50.52%) 
Headache *  24/100 (24.00%)  21/97 (21.65%) 
Dizziness *  12/100 (12.00%)  12/97 (12.37%) 
Psychiatric disorders     
Insomnia *  11/100 (11.00%)  11/97 (11.34%) 
Anxiety *  9/100 (9.00%)  9/97 (9.28%) 
Renal and urinary disorders     
Acute kidney injury *  8/100 (8.00%)  4/97 (4.12%) 
Respiratory, thoracic and mediastinal disorders     
Oropharyngeal pain *  36/100 (36.00%)  40/97 (41.24%) 
Cough *  21/100 (21.00%)  12/97 (12.37%) 
Dysphonia *  20/100 (20.00%)  12/97 (12.37%) 
Productive cough *  8/100 (8.00%)  7/97 (7.22%) 
Dyspnoea *  9/100 (9.00%)  5/97 (5.15%) 
Hiccups *  6/100 (6.00%)  7/97 (7.22%) 
Nasal congestion *  7/100 (7.00%)  3/97 (3.09%) 
Skin and subcutaneous tissue disorders     
Erythema *  15/100 (15.00%)  9/97 (9.28%) 
Rash *  6/100 (6.00%)  3/97 (3.09%) 
Dermatitis *  5/100 (5.00%)  3/97 (3.09%) 
Vascular disorders     
Hypotension *  7/100 (7.00%)  6/97 (6.19%) 
*
Indicates events were collected by non-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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Alan Jolyn
Organization: Oragenics, Inc.
Phone: + 1 813-286-7900
EMail: info@oragenics.com
Layout table for additonal information
Responsible Party: Oragenics, Inc.
ClinicalTrials.gov Identifier: NCT03234465    
Other Study ID Numbers: AG013-ODOM-201
First Submitted: July 21, 2017
First Posted: July 31, 2017
Results First Submitted: October 22, 2020
Results First Posted: November 23, 2020
Last Update Posted: November 23, 2020