Trial Outcomes & Findings for A Clinical Study to Evaluate the Maximum Maxillary Bite Force (BF) When Using Two Novel Denture Adhesives Compared to Using No-Adhesive (NCT NCT05173974)
NCT ID: NCT05173974
Last Updated: 2024-02-16
Results Overview
Natural logged incisal Bite Force (BF) measurements were performed to analyze the denture dislodgement as measure of denture adhesive hold efficacy. All BF measurements were conducted by an examiner. AOB 0-12 was used to assess the incisal BF and defined as (Area under the Curve \[AUC\]0-12) divided by 12 minus baseline BF (pounds \[lbs\]). AUC was calculated from 0 to 12 hours using the trapezoid method; denoted as AUC 0-12. This transformation was carried out to return the measurement to the same scale as the original observation. AOB 0-12 was analyzed for each of the three treatments in comparison to no denture adhesive treatment group. Higher values of AOB 0-12 demonstrate a stronger bite force over time than lower values. Baseline was defined as BF (lbs) recorded at hour 0 (pre-treatment).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
45 participants
Primary outcome timeframe
Baseline and up to 12 hours
Results posted on
2024-02-16
Participant Flow
All participants were recruited at a single center in United States of America (USA).
A total of 52 participants were screened, of which 45 were enrolled (7 screened participants failed to meet the required criteria for study participation). Forty-three participants were randomized to study treatment (2 enrolled participants were not randomized due to lost to follow-up prior to treatment assignment) and 41 participants completed the study.
Participant milestones
| Measure |
Experimental Denture Adhesive 1/Negative Control/Positive Control/Experimental Denture Adhesive 2
Participants in this arm received a single oral topical application of 1.00 +- 0.05 gram of Experimental Denture Adhesive 1, followed by Negative Control (No Denture Adhesive), Positive Control (Super Poligrip Free Denture Adhesive) and Experimental Denture Adhesive 2 in Period 1 (visit 2), Period 2 (Visit 3), Period 3 (Visit 4) and Period 4 (Visit 5) respectively. Each treatment period was separated by a wash out period of at least 1 to 28 days. Study products were applied by site study staff, to clean upper denture fit surface in a pattern consistent with product label and application instructions.
|
Experimental Denture Adhesive 2/Positive Control/Negative Control/Experimental Denture Adhesive 1
Participants in this arm received a single oral topical application of 1.00 +- 0.05 gram of Experimental Denture Adhesive 2, followed by Positive Control (Super Poligrip Free Denture Adhesive), Negative Control (No Denture Adhesive) and Experimental Denture Adhesive 1 in Period 1 (visit 2), Period 2 (Visit 3), Period 3 (Visit 4) and Period 4 (Visit 5) respectively. Each treatment period was separated by a wash out period of at least 1 to 28 days. Study products were applied by site study staff, to clean upper denture fit surface in a pattern consistent with product label and application instructions.
|
Negative Control/Experimental Denture Adhesive 2/Experimental Denture Adhesive 1/Positive Control
Participants in this arm received a single oral topical application of 1.00 +- 0.05 gram of Negative Control (No Denture Adhesive), followed by Experimental Denture Adhesive 2, Experimental Denture Adhesive 1, Positive Control (Super Poligrip Free Denture Adhesive) in Period 1 (visit 2), Period 2 (Visit 3), Period 3 (Visit 4) and Period 4 (Visit 5) respectively. Each treatment period was separated by a wash out period of at least 1 to 28 days. Study products were applied by site study staff, to clean upper denture fit surface in a pattern consistent with product label and application instructions.
|
Positive Control/Experimental Denture Adhesive 1/Experimental Denture Adhesive 2/Negative Control
Participants in this arm received a single oral topical application of 1.00 +- 0.05 gram of Positive Control (Super Poligrip Free Denture Adhesive), followed by Experimental Denture Adhesive 1, Experimental Denture Adhesive 2, Negative Control (No Denture Adhesive) in Period 1 (visit 2), Period 2 (Visit 3), Period 3 (Visit 4) and Period 4 (Visit 5) respectively. Each treatment period was separated by a wash out period of at least 1 to 28 days. Study products were applied by site study staff, to clean upper denture fit surface in a pattern consistent with product label and application instructions.
|
|---|---|---|---|---|
|
Period 1 (Visit 2, 1 Day)
STARTED
|
11
|
10
|
11
|
11
|
|
Period 1 (Visit 2, 1 Day)
COMPLETED
|
11
|
10
|
11
|
11
|
|
Period 1 (Visit 2, 1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout Period 1 (at Least 1 to 28 Days)
STARTED
|
11
|
10
|
11
|
11
|
|
Washout Period 1 (at Least 1 to 28 Days)
COMPLETED
|
11
|
10
|
11
|
11
|
|
Washout Period 1 (at Least 1 to 28 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 2 (Visit 3, 1 Day)
STARTED
|
11
|
9
|
11
|
11
|
|
Period 2 (Visit 3, 1 Day)
COMPLETED
|
11
|
9
|
11
|
10
|
|
Period 2 (Visit 3, 1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
1
|
|
Washout Period 2 (at Least 1 to 28 Days)
STARTED
|
11
|
9
|
11
|
10
|
|
Washout Period 2 (at Least 1 to 28 Days)
COMPLETED
|
11
|
9
|
11
|
10
|
|
Washout Period 2 (at Least 1 to 28 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 3 (Visit 4, 1 Day)
STARTED
|
11
|
10
|
11
|
10
|
|
Period 3 (Visit 4, 1 Day)
COMPLETED
|
11
|
10
|
11
|
10
|
|
Period 3 (Visit 4, 1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout Period 3 (at Least 1 to 28 Days)
STARTED
|
11
|
10
|
11
|
10
|
|
Washout Period 3 (at Least 1 to 28 Days)
COMPLETED
|
11
|
10
|
11
|
10
|
|
Washout Period 3 (at Least 1 to 28 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 4 (Visit 5, 1 Day)
STARTED
|
11
|
10
|
11
|
10
|
|
Period 4 (Visit 5, 1 Day)
COMPLETED
|
11
|
9
|
11
|
10
|
|
Period 4 (Visit 5, 1 Day)
NOT COMPLETED
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Experimental Denture Adhesive 1/Negative Control/Positive Control/Experimental Denture Adhesive 2
Participants in this arm received a single oral topical application of 1.00 +- 0.05 gram of Experimental Denture Adhesive 1, followed by Negative Control (No Denture Adhesive), Positive Control (Super Poligrip Free Denture Adhesive) and Experimental Denture Adhesive 2 in Period 1 (visit 2), Period 2 (Visit 3), Period 3 (Visit 4) and Period 4 (Visit 5) respectively. Each treatment period was separated by a wash out period of at least 1 to 28 days. Study products were applied by site study staff, to clean upper denture fit surface in a pattern consistent with product label and application instructions.
|
Experimental Denture Adhesive 2/Positive Control/Negative Control/Experimental Denture Adhesive 1
Participants in this arm received a single oral topical application of 1.00 +- 0.05 gram of Experimental Denture Adhesive 2, followed by Positive Control (Super Poligrip Free Denture Adhesive), Negative Control (No Denture Adhesive) and Experimental Denture Adhesive 1 in Period 1 (visit 2), Period 2 (Visit 3), Period 3 (Visit 4) and Period 4 (Visit 5) respectively. Each treatment period was separated by a wash out period of at least 1 to 28 days. Study products were applied by site study staff, to clean upper denture fit surface in a pattern consistent with product label and application instructions.
|
Negative Control/Experimental Denture Adhesive 2/Experimental Denture Adhesive 1/Positive Control
Participants in this arm received a single oral topical application of 1.00 +- 0.05 gram of Negative Control (No Denture Adhesive), followed by Experimental Denture Adhesive 2, Experimental Denture Adhesive 1, Positive Control (Super Poligrip Free Denture Adhesive) in Period 1 (visit 2), Period 2 (Visit 3), Period 3 (Visit 4) and Period 4 (Visit 5) respectively. Each treatment period was separated by a wash out period of at least 1 to 28 days. Study products were applied by site study staff, to clean upper denture fit surface in a pattern consistent with product label and application instructions.
|
Positive Control/Experimental Denture Adhesive 1/Experimental Denture Adhesive 2/Negative Control
Participants in this arm received a single oral topical application of 1.00 +- 0.05 gram of Positive Control (Super Poligrip Free Denture Adhesive), followed by Experimental Denture Adhesive 1, Experimental Denture Adhesive 2, Negative Control (No Denture Adhesive) in Period 1 (visit 2), Period 2 (Visit 3), Period 3 (Visit 4) and Period 4 (Visit 5) respectively. Each treatment period was separated by a wash out period of at least 1 to 28 days. Study products were applied by site study staff, to clean upper denture fit surface in a pattern consistent with product label and application instructions.
|
|---|---|---|---|---|
|
Period 2 (Visit 3, 1 Day)
Baseline bite was not eligible
|
0
|
0
|
0
|
1
|
|
Period 4 (Visit 5, 1 Day)
Baseline bite was not eligible
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Clinical Study to Evaluate the Maximum Maxillary Bite Force (BF) When Using Two Novel Denture Adhesives Compared to Using No-Adhesive
Baseline characteristics by cohort
| Measure |
Overall Study Participants
n=43 Participants
Participants received a single oral topical application of 1.00 +- 0.05 gram of Experimental Denture Adhesive 1, Experimental Denture Adhesive 2, Positive control (Super Poligrip Free Denture Adhesive) to the upper denture or Negative control (No Denture Adhesive) as per randomization schedule. Study products were applied by site study staff, to clean upper denture fit surface in a pattern consistent with product label and application instructions.
|
|---|---|
|
Age, Continuous
|
70.1 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and up to 12 hoursPopulation: mITT population. Only those participants available at the indicated timepoints were analyzed.
Natural logged incisal Bite Force (BF) measurements were performed to analyze the denture dislodgement as measure of denture adhesive hold efficacy. All BF measurements were conducted by an examiner. AOB 0-12 was used to assess the incisal BF and defined as (Area under the Curve \[AUC\]0-12) divided by 12 minus baseline BF (pounds \[lbs\]). AUC was calculated from 0 to 12 hours using the trapezoid method; denoted as AUC 0-12. This transformation was carried out to return the measurement to the same scale as the original observation. AOB 0-12 was analyzed for each of the three treatments in comparison to no denture adhesive treatment group. Higher values of AOB 0-12 demonstrate a stronger bite force over time than lower values. Baseline was defined as BF (lbs) recorded at hour 0 (pre-treatment).
Outcome measures
| Measure |
Experimental Denture Adhesive 1
n=41 Participants
Participants of this arm received a single oral topical application of 1.00 +- 0.05 gram of Experimental Denture Adhesive 1 to the upper denture applied by site study staff, to clean dry denture fit surface in a pattern consistent with product label and application instructions.
|
Experimental Denture Adhesive 2
n=42 Participants
Participants of this arm received a single oral topical application of 1.00 +- 0.05 gram of Experimental Denture Adhesive 2 to the upper denture applied by site study staff, to clean dry denture fit surface in a pattern consistent with product label and application instructions.
|
Positive Control
n=42 Participants
Participants of this arm received a single oral topical application of 1.00 +- 0.05 gram of Positive control (Super Poligrip Free denture adhesive) to the upper denture applied by site study staff, to clean dry denture fit surface in a pattern consistent with product label and application instructions.
|
Negative Control
n=42 Participants
Participants of this arm did not receive any adhesive to apply on upper denture.
|
|---|---|---|---|---|
|
Area Over Baseline Over 12 Hours (AOB 0-12) to Compare Maximum Incisal Bite Force
|
0.87 lbs
Standard Deviation 0.80
|
0.69 lbs
Standard Deviation 0.70
|
0.89 lbs
Standard Deviation 0.86
|
0.59 lbs
Standard Deviation 0.71
|
SECONDARY outcome
Timeframe: Baseline, at 0.5, 1, 3, 6 and 9 hoursPopulation: mITT population. Only those participants available at the indicated timepoints were analyzed.
Natural logged incisal BF measurements were performed to analyze the denture dislodgement as measure of denture adhesive hold efficacy. All BF measurements were conducted by an examiner. AOB 0-t was defined as AUC 0-t divided by "t" minus baseline BF (lbs), where "t" is equal to 0.5, 1, 3, 6 and 9 hours. AUC was calculated from 0 to "t" hours using the trapezoid method; denoted as AUC 0-t. This transformation was carried out to return the measurement to the same scale as the original observation. AOB for 0.5, 1, 3, 6 and 9 hours were analyzed using the trapezoid method. AOB 0-0.5, AOB 0-1, AOB 0-3, AOB 0-6, AOB 0-9 were analyzed for each of the three treatments in comparison to no adhesive treatment group. Higher values of AOB demonstrate a stronger bite force over time than lower values. Baseline was defined as BF (lbs) recorded at hour 0 (pre-treatment).
Outcome measures
| Measure |
Experimental Denture Adhesive 1
n=41 Participants
Participants of this arm received a single oral topical application of 1.00 +- 0.05 gram of Experimental Denture Adhesive 1 to the upper denture applied by site study staff, to clean dry denture fit surface in a pattern consistent with product label and application instructions.
|
Experimental Denture Adhesive 2
n=42 Participants
Participants of this arm received a single oral topical application of 1.00 +- 0.05 gram of Experimental Denture Adhesive 2 to the upper denture applied by site study staff, to clean dry denture fit surface in a pattern consistent with product label and application instructions.
|
Positive Control
n=42 Participants
Participants of this arm received a single oral topical application of 1.00 +- 0.05 gram of Positive control (Super Poligrip Free denture adhesive) to the upper denture applied by site study staff, to clean dry denture fit surface in a pattern consistent with product label and application instructions.
|
Negative Control
n=42 Participants
Participants of this arm did not receive any adhesive to apply on upper denture.
|
|---|---|---|---|---|
|
Area Over Baseline at 0.5, 1, 3, 6 And 9 Hours to Compare Maximum Incisal BF
AOB 0-0.5
|
0.40 lbs
Standard Deviation 0.36
|
0.34 lbs
Standard Deviation 0.40
|
0.47 lbs
Standard Deviation 0.48
|
0.26 lbs
Standard Deviation 0.37
|
|
Area Over Baseline at 0.5, 1, 3, 6 And 9 Hours to Compare Maximum Incisal BF
AOB 0-1
|
0.64 lbs
Standard Deviation 0.52
|
0.51 lbs
Standard Deviation 0.56
|
0.71 lbs
Standard Deviation 0.65
|
0.40 lbs
Standard Deviation 0.52
|
|
Area Over Baseline at 0.5, 1, 3, 6 And 9 Hours to Compare Maximum Incisal BF
AOB 0-3
|
0.84 lbs
Standard Deviation 0.65
|
0.65 lbs
Standard Deviation 0.63
|
0.84 lbs
Standard Deviation 0.74
|
0.54 lbs
Standard Deviation 0.63
|
|
Area Over Baseline at 0.5, 1, 3, 6 And 9 Hours to Compare Maximum Incisal BF
AOB 0-6
|
0.86 lbs
Standard Deviation 0.75
|
0.71 lbs
Standard Deviation 0.68
|
0.88 lbs
Standard Deviation 0.82
|
0.58 lbs
Standard Deviation 0.68
|
|
Area Over Baseline at 0.5, 1, 3, 6 And 9 Hours to Compare Maximum Incisal BF
AOB 0-9
|
0.85 lbs
Standard Deviation 0.79
|
0.71 lbs
Standard Deviation 0.69
|
0.89 lbs
Standard Deviation 0.85
|
0.58 lbs
Standard Deviation 0.70
|
Adverse Events
Experimental Denture Adhesive 1
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Experimental Denture Adhesive 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Positive Control
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Negative Control
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Experimental Denture Adhesive 1
n=41 participants at risk
Participants of this arm received a single oral topical application of 1.00 +- 0.05 gram of Experimental Denture Adhesive 1 to the upper denture applied by site study staff, to clean dry denture fit surface in a pattern consistent with product label and application instructions.
|
Experimental Denture Adhesive 2
n=42 participants at risk
Participants of this arm received a single oral topical application of 1.00 +- 0.05 gram of Experimental Denture Adhesive 2 to the upper denture applied by site study staff, to clean dry denture fit surface in a pattern consistent with product label and application instructions.
|
Positive Control
n=42 participants at risk
Participants of this arm received a single oral topical application of 1.00 +- 0.05 gram of Positive control (Super Poligrip Free denture adhesive) to the upper denture applied by site study staff, to clean dry denture fit surface in a pattern consistent with product label and application instructions.
|
Negative Control
n=42 participants at risk
Participants of this arm did not receive any adhesive to apply on upper denture.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
2.4%
1/41 • All-cause mortality, Serious Adverse Events (SAEs), Non-SAEs and Medical Device incidents were collected from immediately after signing of informed consent until 5 days following last administration of the study product (Visit 5 treatment Period 4) (Collected up to 39 days)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious. Treatment emergent adverse events were presented treatment wise.
|
0.00%
0/42 • All-cause mortality, Serious Adverse Events (SAEs), Non-SAEs and Medical Device incidents were collected from immediately after signing of informed consent until 5 days following last administration of the study product (Visit 5 treatment Period 4) (Collected up to 39 days)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious. Treatment emergent adverse events were presented treatment wise.
|
0.00%
0/42 • All-cause mortality, Serious Adverse Events (SAEs), Non-SAEs and Medical Device incidents were collected from immediately after signing of informed consent until 5 days following last administration of the study product (Visit 5 treatment Period 4) (Collected up to 39 days)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious. Treatment emergent adverse events were presented treatment wise.
|
0.00%
0/42 • All-cause mortality, Serious Adverse Events (SAEs), Non-SAEs and Medical Device incidents were collected from immediately after signing of informed consent until 5 days following last administration of the study product (Visit 5 treatment Period 4) (Collected up to 39 days)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious. Treatment emergent adverse events were presented treatment wise.
|
|
Gastrointestinal disorders
Mouth ulceration
|
2.4%
1/41 • All-cause mortality, Serious Adverse Events (SAEs), Non-SAEs and Medical Device incidents were collected from immediately after signing of informed consent until 5 days following last administration of the study product (Visit 5 treatment Period 4) (Collected up to 39 days)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious. Treatment emergent adverse events were presented treatment wise.
|
2.4%
1/42 • All-cause mortality, Serious Adverse Events (SAEs), Non-SAEs and Medical Device incidents were collected from immediately after signing of informed consent until 5 days following last administration of the study product (Visit 5 treatment Period 4) (Collected up to 39 days)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious. Treatment emergent adverse events were presented treatment wise.
|
2.4%
1/42 • All-cause mortality, Serious Adverse Events (SAEs), Non-SAEs and Medical Device incidents were collected from immediately after signing of informed consent until 5 days following last administration of the study product (Visit 5 treatment Period 4) (Collected up to 39 days)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious. Treatment emergent adverse events were presented treatment wise.
|
2.4%
1/42 • All-cause mortality, Serious Adverse Events (SAEs), Non-SAEs and Medical Device incidents were collected from immediately after signing of informed consent until 5 days following last administration of the study product (Visit 5 treatment Period 4) (Collected up to 39 days)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious. Treatment emergent adverse events were presented treatment wise.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus headache
|
0.00%
0/41 • All-cause mortality, Serious Adverse Events (SAEs), Non-SAEs and Medical Device incidents were collected from immediately after signing of informed consent until 5 days following last administration of the study product (Visit 5 treatment Period 4) (Collected up to 39 days)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious. Treatment emergent adverse events were presented treatment wise.
|
0.00%
0/42 • All-cause mortality, Serious Adverse Events (SAEs), Non-SAEs and Medical Device incidents were collected from immediately after signing of informed consent until 5 days following last administration of the study product (Visit 5 treatment Period 4) (Collected up to 39 days)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious. Treatment emergent adverse events were presented treatment wise.
|
0.00%
0/42 • All-cause mortality, Serious Adverse Events (SAEs), Non-SAEs and Medical Device incidents were collected from immediately after signing of informed consent until 5 days following last administration of the study product (Visit 5 treatment Period 4) (Collected up to 39 days)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious. Treatment emergent adverse events were presented treatment wise.
|
2.4%
1/42 • All-cause mortality, Serious Adverse Events (SAEs), Non-SAEs and Medical Device incidents were collected from immediately after signing of informed consent until 5 days following last administration of the study product (Visit 5 treatment Period 4) (Collected up to 39 days)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious. Treatment emergent adverse events were presented treatment wise.
|
|
Respiratory, thoracic and mediastinal disorders
Musculoskeletal chest pain
|
0.00%
0/41 • All-cause mortality, Serious Adverse Events (SAEs), Non-SAEs and Medical Device incidents were collected from immediately after signing of informed consent until 5 days following last administration of the study product (Visit 5 treatment Period 4) (Collected up to 39 days)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious. Treatment emergent adverse events were presented treatment wise.
|
0.00%
0/42 • All-cause mortality, Serious Adverse Events (SAEs), Non-SAEs and Medical Device incidents were collected from immediately after signing of informed consent until 5 days following last administration of the study product (Visit 5 treatment Period 4) (Collected up to 39 days)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious. Treatment emergent adverse events were presented treatment wise.
|
2.4%
1/42 • All-cause mortality, Serious Adverse Events (SAEs), Non-SAEs and Medical Device incidents were collected from immediately after signing of informed consent until 5 days following last administration of the study product (Visit 5 treatment Period 4) (Collected up to 39 days)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious. Treatment emergent adverse events were presented treatment wise.
|
0.00%
0/42 • All-cause mortality, Serious Adverse Events (SAEs), Non-SAEs and Medical Device incidents were collected from immediately after signing of informed consent until 5 days following last administration of the study product (Visit 5 treatment Period 4) (Collected up to 39 days)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious. Treatment emergent adverse events were presented treatment wise.
|
|
Gastrointestinal disorders
Oral mucosal erythema
|
2.4%
1/41 • All-cause mortality, Serious Adverse Events (SAEs), Non-SAEs and Medical Device incidents were collected from immediately after signing of informed consent until 5 days following last administration of the study product (Visit 5 treatment Period 4) (Collected up to 39 days)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious. Treatment emergent adverse events were presented treatment wise.
|
0.00%
0/42 • All-cause mortality, Serious Adverse Events (SAEs), Non-SAEs and Medical Device incidents were collected from immediately after signing of informed consent until 5 days following last administration of the study product (Visit 5 treatment Period 4) (Collected up to 39 days)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious. Treatment emergent adverse events were presented treatment wise.
|
2.4%
1/42 • All-cause mortality, Serious Adverse Events (SAEs), Non-SAEs and Medical Device incidents were collected from immediately after signing of informed consent until 5 days following last administration of the study product (Visit 5 treatment Period 4) (Collected up to 39 days)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious. Treatment emergent adverse events were presented treatment wise.
|
0.00%
0/42 • All-cause mortality, Serious Adverse Events (SAEs), Non-SAEs and Medical Device incidents were collected from immediately after signing of informed consent until 5 days following last administration of the study product (Visit 5 treatment Period 4) (Collected up to 39 days)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious. Treatment emergent adverse events were presented treatment wise.
|
|
Gastrointestinal disorders
Oral discomfort
|
2.4%
1/41 • All-cause mortality, Serious Adverse Events (SAEs), Non-SAEs and Medical Device incidents were collected from immediately after signing of informed consent until 5 days following last administration of the study product (Visit 5 treatment Period 4) (Collected up to 39 days)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious. Treatment emergent adverse events were presented treatment wise.
|
0.00%
0/42 • All-cause mortality, Serious Adverse Events (SAEs), Non-SAEs and Medical Device incidents were collected from immediately after signing of informed consent until 5 days following last administration of the study product (Visit 5 treatment Period 4) (Collected up to 39 days)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious. Treatment emergent adverse events were presented treatment wise.
|
2.4%
1/42 • All-cause mortality, Serious Adverse Events (SAEs), Non-SAEs and Medical Device incidents were collected from immediately after signing of informed consent until 5 days following last administration of the study product (Visit 5 treatment Period 4) (Collected up to 39 days)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious. Treatment emergent adverse events were presented treatment wise.
|
0.00%
0/42 • All-cause mortality, Serious Adverse Events (SAEs), Non-SAEs and Medical Device incidents were collected from immediately after signing of informed consent until 5 days following last administration of the study product (Visit 5 treatment Period 4) (Collected up to 39 days)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious. Treatment emergent adverse events were presented treatment wise.
|
|
Gastrointestinal disorders
Oral pruritus
|
2.4%
1/41 • All-cause mortality, Serious Adverse Events (SAEs), Non-SAEs and Medical Device incidents were collected from immediately after signing of informed consent until 5 days following last administration of the study product (Visit 5 treatment Period 4) (Collected up to 39 days)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious. Treatment emergent adverse events were presented treatment wise.
|
0.00%
0/42 • All-cause mortality, Serious Adverse Events (SAEs), Non-SAEs and Medical Device incidents were collected from immediately after signing of informed consent until 5 days following last administration of the study product (Visit 5 treatment Period 4) (Collected up to 39 days)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious. Treatment emergent adverse events were presented treatment wise.
|
2.4%
1/42 • All-cause mortality, Serious Adverse Events (SAEs), Non-SAEs and Medical Device incidents were collected from immediately after signing of informed consent until 5 days following last administration of the study product (Visit 5 treatment Period 4) (Collected up to 39 days)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious. Treatment emergent adverse events were presented treatment wise.
|
0.00%
0/42 • All-cause mortality, Serious Adverse Events (SAEs), Non-SAEs and Medical Device incidents were collected from immediately after signing of informed consent until 5 days following last administration of the study product (Visit 5 treatment Period 4) (Collected up to 39 days)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious. Treatment emergent adverse events were presented treatment wise.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/41 • All-cause mortality, Serious Adverse Events (SAEs), Non-SAEs and Medical Device incidents were collected from immediately after signing of informed consent until 5 days following last administration of the study product (Visit 5 treatment Period 4) (Collected up to 39 days)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious. Treatment emergent adverse events were presented treatment wise.
|
2.4%
1/42 • All-cause mortality, Serious Adverse Events (SAEs), Non-SAEs and Medical Device incidents were collected from immediately after signing of informed consent until 5 days following last administration of the study product (Visit 5 treatment Period 4) (Collected up to 39 days)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious. Treatment emergent adverse events were presented treatment wise.
|
2.4%
1/42 • All-cause mortality, Serious Adverse Events (SAEs), Non-SAEs and Medical Device incidents were collected from immediately after signing of informed consent until 5 days following last administration of the study product (Visit 5 treatment Period 4) (Collected up to 39 days)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious. Treatment emergent adverse events were presented treatment wise.
|
0.00%
0/42 • All-cause mortality, Serious Adverse Events (SAEs), Non-SAEs and Medical Device incidents were collected from immediately after signing of informed consent until 5 days following last administration of the study product (Visit 5 treatment Period 4) (Collected up to 39 days)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious. Treatment emergent adverse events were presented treatment wise.
|
|
Gastrointestinal disorders
Gingival injury
|
2.4%
1/41 • All-cause mortality, Serious Adverse Events (SAEs), Non-SAEs and Medical Device incidents were collected from immediately after signing of informed consent until 5 days following last administration of the study product (Visit 5 treatment Period 4) (Collected up to 39 days)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious. Treatment emergent adverse events were presented treatment wise.
|
2.4%
1/42 • All-cause mortality, Serious Adverse Events (SAEs), Non-SAEs and Medical Device incidents were collected from immediately after signing of informed consent until 5 days following last administration of the study product (Visit 5 treatment Period 4) (Collected up to 39 days)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious. Treatment emergent adverse events were presented treatment wise.
|
0.00%
0/42 • All-cause mortality, Serious Adverse Events (SAEs), Non-SAEs and Medical Device incidents were collected from immediately after signing of informed consent until 5 days following last administration of the study product (Visit 5 treatment Period 4) (Collected up to 39 days)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious. Treatment emergent adverse events were presented treatment wise.
|
2.4%
1/42 • All-cause mortality, Serious Adverse Events (SAEs), Non-SAEs and Medical Device incidents were collected from immediately after signing of informed consent until 5 days following last administration of the study product (Visit 5 treatment Period 4) (Collected up to 39 days)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious. Treatment emergent adverse events were presented treatment wise.
|
|
Injury, poisoning and procedural complications
Lip injury
|
2.4%
1/41 • All-cause mortality, Serious Adverse Events (SAEs), Non-SAEs and Medical Device incidents were collected from immediately after signing of informed consent until 5 days following last administration of the study product (Visit 5 treatment Period 4) (Collected up to 39 days)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious. Treatment emergent adverse events were presented treatment wise.
|
0.00%
0/42 • All-cause mortality, Serious Adverse Events (SAEs), Non-SAEs and Medical Device incidents were collected from immediately after signing of informed consent until 5 days following last administration of the study product (Visit 5 treatment Period 4) (Collected up to 39 days)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious. Treatment emergent adverse events were presented treatment wise.
|
0.00%
0/42 • All-cause mortality, Serious Adverse Events (SAEs), Non-SAEs and Medical Device incidents were collected from immediately after signing of informed consent until 5 days following last administration of the study product (Visit 5 treatment Period 4) (Collected up to 39 days)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious. Treatment emergent adverse events were presented treatment wise.
|
0.00%
0/42 • All-cause mortality, Serious Adverse Events (SAEs), Non-SAEs and Medical Device incidents were collected from immediately after signing of informed consent until 5 days following last administration of the study product (Visit 5 treatment Period 4) (Collected up to 39 days)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious. Treatment emergent adverse events were presented treatment wise.
|
|
Gastrointestinal disorders
Mouth injury
|
0.00%
0/41 • All-cause mortality, Serious Adverse Events (SAEs), Non-SAEs and Medical Device incidents were collected from immediately after signing of informed consent until 5 days following last administration of the study product (Visit 5 treatment Period 4) (Collected up to 39 days)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious. Treatment emergent adverse events were presented treatment wise.
|
0.00%
0/42 • All-cause mortality, Serious Adverse Events (SAEs), Non-SAEs and Medical Device incidents were collected from immediately after signing of informed consent until 5 days following last administration of the study product (Visit 5 treatment Period 4) (Collected up to 39 days)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious. Treatment emergent adverse events were presented treatment wise.
|
2.4%
1/42 • All-cause mortality, Serious Adverse Events (SAEs), Non-SAEs and Medical Device incidents were collected from immediately after signing of informed consent until 5 days following last administration of the study product (Visit 5 treatment Period 4) (Collected up to 39 days)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious. Treatment emergent adverse events were presented treatment wise.
|
0.00%
0/42 • All-cause mortality, Serious Adverse Events (SAEs), Non-SAEs and Medical Device incidents were collected from immediately after signing of informed consent until 5 days following last administration of the study product (Visit 5 treatment Period 4) (Collected up to 39 days)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious. Treatment emergent adverse events were presented treatment wise.
|
|
Injury, poisoning and procedural complications
Limb injury
|
2.4%
1/41 • All-cause mortality, Serious Adverse Events (SAEs), Non-SAEs and Medical Device incidents were collected from immediately after signing of informed consent until 5 days following last administration of the study product (Visit 5 treatment Period 4) (Collected up to 39 days)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious. Treatment emergent adverse events were presented treatment wise.
|
0.00%
0/42 • All-cause mortality, Serious Adverse Events (SAEs), Non-SAEs and Medical Device incidents were collected from immediately after signing of informed consent until 5 days following last administration of the study product (Visit 5 treatment Period 4) (Collected up to 39 days)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious. Treatment emergent adverse events were presented treatment wise.
|
0.00%
0/42 • All-cause mortality, Serious Adverse Events (SAEs), Non-SAEs and Medical Device incidents were collected from immediately after signing of informed consent until 5 days following last administration of the study product (Visit 5 treatment Period 4) (Collected up to 39 days)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious. Treatment emergent adverse events were presented treatment wise.
|
0.00%
0/42 • All-cause mortality, Serious Adverse Events (SAEs), Non-SAEs and Medical Device incidents were collected from immediately after signing of informed consent until 5 days following last administration of the study product (Visit 5 treatment Period 4) (Collected up to 39 days)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious. Treatment emergent adverse events were presented treatment wise.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee HALEON agreements may vary with individual investigators but will not prohibit any investigator from publishing. HALEON supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER