Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Investigation of non-CE marked intermittent catheters. The study was a randomized, single blinded, cross-over investigation comparing two new catheters with a comparator catheter in 30 adult healthy volunteers.
The CP322 study investigated a novel non-CE marked intermittent catheter for males and females, designed in two different variants, Variant 1 and Variant 2, respectively. The study was conducted in Denmark and was a randomized, single blinded, cross-over investigation comparing the two new variant catheters with a comparator catheter in 30 adult healthy volunteers.
For each participant, the study thus contained three test visits/treatment arms (Comparator, Variant 1 and Variant 2, respectively), to which the 30 participants were randomized using a randomization sequence of six (i.e., there were six different random options for the order in which the participants tested the three catheters). There were 4-14 days between the test visits.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intermittent catheter; SpeediCath® Standard male or female | Active Comparator | Participants underwent catheterization with standard of care intermittent catheter. The catheterization was performed by a trained nurse. |
|
| New intermittent catheter Variant 1 for male or female | Experimental | Participants underwent catheterization with the new intermittent catheter Variant 1 for males or females. The catheterization was performed by a trained nurse. |
|
| New intermittent catheter Variant 2 for male or female | Experimental | Participants underwent catheterization with the new intermittent catheter Variant 2 for males or females. The catheterization was performed by a trained nurse. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SpeediCath® Standard male or female | Device | Intermittent catheterization through the urethra draining the bladder, using SpeediCath® Standard male or female. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Residual Urine at 1st Flow-stop | The residual urine at 1st flow-stop during catheterization (performed by a nurse) represents the volume of urine left in the bladder, the first time the urine stops running out of the catheter during bladder emptying/urination. This was assessed using a pressure sensor with time-logged weighing, meaning that a flow-stop was registered measuring the hydrostatic pressure at the outlet of an intermittent urinary catheter. Simultaneously, the collected urine was weighed and converted to volume, and the residual volume at first flow stop was calculated as the difference between the total urine volume collected and the volume collected at the first flow-stop. | Immediately after the procedure/catheterization, up to 5 min. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-void Residual Urine | The volume of residual urine (urine left in the bladder) post catheterization (performed by the nurse) measured in triplicates using an ultrasound scanner. | Immediately after the procedure/catheterization, up to 15 min. |
| Catheterization Insertion Discomfort |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Per Bagi, MD | Blegdamsvej 9, Urologisk klinik Afsnit 2112, Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urologisk klinik, Afsnit 2112, Rigshospitalet | Copenhagen | Copenhagen Ø | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37966080 | Derived | Landauro MH, Tentor F, Pedersen T, Jacobsen L, Bagi P. Improved Performance With the Micro-Hole Zone Intermittent Catheter: A Combined Analysis of 3 Randomized Controlled Studies Comparing the New Catheter Technology With a Conventional Eyelet Catheter. J Wound Ostomy Continence Nurs. 2023 Nov-Dec 01;50(6):504-511. doi: 10.1097/WON.0000000000001029. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The 30 recruited participant were randomized into the three treatment arms, using a randomization sequence of six. No participants were excluded, one was discontinued after Visit 2 due to an adverse event.
Two participants total had an adverse event, both were classified as mild, non-serious, 'Possibly related' and 'Not related' (for details; see Adverse Events section).
Thus, 30 participants constituted the intention to treat (ITT) population.
Between March 2020 and September 2020, 30 users were recruited for the study from one site (Denmark) and encompassed the safety population.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Comparator, Then Variant 2, Then Variant 1 | On three separate visits and in the listed random order, the participants underwent three interventions: First intervention: Day of catheterization with Comparator. Washout: 4-14 days. Second intervention: Day of catheterization with Variant 2. Washout: 4-14 days. Third intervention: Day of catheterization with Variant 1. |
| FG001 | Variant 2, Then Variant 1, Then Comparator | On three separate visits and in the listed random order, the participants underwent three interventions: First intervention: Day of catheterization with Variant 2. Washout: 4-14 days. Second intervention: Day of catheterization with Variant 1. Washout: 4-14 days. Third intervention: Day of catheterization with Comparator. |
| FG002 | Comparator, Then Variant 1, Then Variant 2 | On three separate visits and in the listed random order, the participants underwent three interventions: First intervention: Day of catheterization with Comparator. Washout: 4-14 days. Second intervention: Day of catheterization with Variant 1. Washout: 4-14 days. Third intervention: Day of catheterization with Variant 2. |
| FG003 | Variant 1, Then Comparator, Then Variant 2 | On three separate visits and in the listed random order, the participants underwent three interventions: First intervention: Day of catheterization with Variant 1. Washout: 4-14 days. Second intervention: Day of catheterization with Comparator. Washout: 4-14 days. Third intervention: Day of catheterization with Variant 2. |
| FG004 | Variant 1, Then Variant 2, Then Comparator | On three separate visits and in the listed random order, the participants underwent three interventions: First intervention: Day of catheterization with Variant 1. Washout: 4-14 days. Second intervention: Day of catheterization with Variant 2. Washout: 4-14 days. Third intervention: Day of catheterization with Comparator. |
| FG005 | Variant 2, Then Comparator, Then Variant 1 | On three separate visits and in the listed random order, the participants underwent three interventions: First intervention: Day of catheterization with Variant 2. Washout: 4-14 days. Second intervention: Day of catheterization with Comparator. Washout: 4-14 days. Third intervention: Day of catheterization with Variant 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Female ITT Population | Each treatment arm consisted of three test visits with 4-14 days between each crossover. On each visit, the participants underwent intermittent catheterization through the urethra, draining the bladder, and tested a different intermittent catheter: The comparator catheter (SpeediCath® Standard female), the new Variant 1 female catheter, or the new Variant 2 female catheter. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Residual Urine at 1st Flow-stop | The residual urine at 1st flow-stop during catheterization (performed by a nurse) represents the volume of urine left in the bladder, the first time the urine stops running out of the catheter during bladder emptying/urination. This was assessed using a pressure sensor with time-logged weighing, meaning that a flow-stop was registered measuring the hydrostatic pressure at the outlet of an intermittent urinary catheter. Simultaneously, the collected urine was weighed and converted to volume, and the residual volume at first flow stop was calculated as the difference between the total urine volume collected and the volume collected at the first flow-stop. | The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoints. | Posted | Mean | Standard Deviation | mL | Immediately after the procedure/catheterization, up to 5 min. |
|
Each participant was enrolled for 3 x 4-14 days for the entire investigation, thus a maximum of 42 days.
The relationship to the investigational or comparator products was collected. The safety population constituted the subjects who had given informed consent and were thus 30 participants.
An adverse event was reported as either: "Not related", "Unlikely related", "Possibly related", "Probably related", or "Definitely related", to the comparator to the Variant 1 or Variant 2 products.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intermittent Catheter; SpeediCath® Standard Female | Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with standard of care intermittent catheter; SpeediCath® Standard female (active comparator). The catheterizations were performed by a trained nurses. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Possibly related | Renal and urinary disorders | Non-systematic Assessment | Urinary tract infection (UTI) |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Medical Affairs | Coloplast A/S | +4549111111 | clinical-studies@coloplast.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 23, 2020 | Aug 4, 2022 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D016055 | Urinary Retention |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| New intermittent Variant 1 catheter for male or female | Device | Intermittent catheterization through the urethra draining the bladder, using the new Variant 1 for male or female. |
|
| New intermittent Variant 2 catheter for male or female | Device | Intermittent catheterization through the urethra draining the bladder, using the new Variant 2 for male or female. |
|
Discomfort measured at catheter insertion, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score. |
| Immediately after the procedure/catheterization, up to 5 min. |
| Catheterization Urination Discomfort | Discomfort measured during catheter emptying/urination, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score. | Immediately after the procedure/catheterization, up to 5 min. |
| Withdrawal Discomfort | Discomfort measured during catheter withdrawal, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score. | Immediately after the procedure/catheterization, up to 5 min. |
| Overall Catheterization Discomfort | Discomfort measured for the overall/entire catheterization procedure, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score. | Immediately after the procedure/catheterization, up to 5 min. |
| Post-catheterization Urination Discomfort | Discomfort measured for the first normal void/urination after the catheterization procedure, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score. | Immediately after the first normal void following the procedure/catheterization, up to 5 min. |
| BG001 | Male ITT Population | Each treatment arm consisted of three test visits with 4-14 days between each crossover. On each visit, the participants underwent intermittent catheterization through the urethra, draining the bladder, and tested a different intermittent catheter: The comparator catheter (SpeediCath® Standard male), the new Variant 1 male catheter, or the new Variant 2 male catheter. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Hematuria positive | Blood in the urine; dipstick analysis positive. | Count of Participants | Participants |
|
| Hematuria negative | Blood in the urine; dipstick analysis negative. | Count of Participants | Participants |
|
| Intermittent Catheter; SpeediCath® Standard Female |
Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with standard of care intermittent catheter; SpeediCath® Standard female (active comparator). The catheterizations were performed by a trained nurses. |
| OG001 | New Intermittent Catheter Variant 1 for Female | Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 1 for females. The catheterizations were performed by a trained nurses. |
| OG002 | New Intermittent Catheter Variant 2 for Female | Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 2 for females. The catheterizations were performed by a trained nurses. |
| OG003 | Intermittent Catheter; SpeediCath® Standard Male | Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with standard of care intermittent catheter; SpeediCath® Standard male (active comparator). The catheterizations were performed by a trained nurses. |
| OG004 | New Intermittent Catheter Variant 1 for Male | Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 1 for males. The catheterizations were performed by a trained nurses. |
| OG005 | New Intermittent Catheter Variant 2 for Male | Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 2 for males. The catheterizations were performed by a trained nurses. |
|
|
|
| Secondary | Post-void Residual Urine | The volume of residual urine (urine left in the bladder) post catheterization (performed by the nurse) measured in triplicates using an ultrasound scanner. | The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoints. | Posted | Mean | Standard Deviation | mL | Immediately after the procedure/catheterization, up to 15 min. |
|
|
|
|
| Secondary | Catheterization Insertion Discomfort | Discomfort measured at catheter insertion, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score. | The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoints. | Posted | Mean | Standard Deviation | cm | Immediately after the procedure/catheterization, up to 5 min. |
|
|
|
|
| Secondary | Catheterization Urination Discomfort | Discomfort measured during catheter emptying/urination, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score. | The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoints. | Posted | Mean | Standard Deviation | cm | Immediately after the procedure/catheterization, up to 5 min. |
|
|
|
|
| Secondary | Withdrawal Discomfort | Discomfort measured during catheter withdrawal, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score. | The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoints. | Posted | Mean | Standard Deviation | cm | Immediately after the procedure/catheterization, up to 5 min. |
|
|
|
|
| Secondary | Overall Catheterization Discomfort | Discomfort measured for the overall/entire catheterization procedure, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score. | The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoints. | Posted | Mean | Standard Deviation | cm | Immediately after the procedure/catheterization, up to 5 min. |
|
|
|
|
| Secondary | Post-catheterization Urination Discomfort | Discomfort measured for the first normal void/urination after the catheterization procedure, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score. | The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoints. | Posted | Mean | Standard Deviation | cm | Immediately after the first normal void following the procedure/catheterization, up to 5 min. |
|
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | New Intermittent Catheter Variant 1 for Female | Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 1 for females. The catheterizations were performed by a trained nurses. | 0 | 15 | 0 | 15 | 0 | 15 |
| EG002 | New Intermittent Catheter Variant 2 for Female | Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 2 for females. The catheterizations were performed by a trained nurses. | 0 | 15 | 0 | 15 | 0 | 15 |
| EG003 | Intermittent Catheter; SpeediCath® Standard Male | Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with standard of care intermittent catheter; SpeediCath® Standard male (active comparator). The catheterizations were performed by a trained nurses. | 0 | 15 | 0 | 15 | 0 | 15 |
| EG004 | New Intermittent Catheter Variant 1 for Male | Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 1 for males. The catheterizations were performed by a trained nurses. | 0 | 15 | 0 | 15 | 1 | 15 |
| EG005 | New Intermittent Catheter Variant 2 for Male | Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 2 for males. The catheterizations were performed by a trained nurses. | 0 | 14 | 0 | 14 | 0 | 14 |
|
Not provided
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied. | Mixed Models Analysis | Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females) | 0.375 | The P-values were not adjusted for multiple comparisons. | Mean Difference (Final Values) | -18.1 | 2-Sided | 95 | -58.7 | 22.4 | Superiority |
| Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied. | Mixed Models Analysis | Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females) | 0.188 | The P-values were not adjusted for multiple comparisons. | Mean Difference (Final Values) | -27.0 | 2-Sided | 95 | -67.6 | 13.6 | Superiority |
| Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied. | Mixed Models Analysis | Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females) | 0.361 | The P-values were not adjusted for multiple comparisons. | Mean Difference (Final Values) | -18.6 | 2-Sided | 95 | -59.3 | 21.9 | Superiority |
| Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied. | Mixed Models Analysis | Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females) | 0.600 | The P-values were not adjusted for multiple comparisons. | Mean Difference (Final Values) | -10.9 | 2-Sided | 95 | -52.3 | 30.5 | Superiority |
| Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied. | Mixed Models Analysis | Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females) | 0.707 | The P-values were not adjusted for multiple comparisons. | Mean Difference (Final Values) | 7.78 | 2-Sided | 95 | -33.5 | 49.0 | Superiority |
| Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied. | Mixed Models Analysis | Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females) | 0.480 | The P-values were not adjusted for multiple comparisons. | Mean Difference (Final Values) | -0.31 | 2-Sided | 95 | -1.17 | 0.56 | Superiority |
| Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied. | Mixed Models Analysis | Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females) | 0.839 | The P-values were not adjusted for multiple comparisons. | Mean Difference (Final Values) | -0.09 | 2-Sided | 95 | -0.95 | 0.77 | Superiority |
| Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied. | Mixed Models Analysis | Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females) | 0.894 | The P-values were not adjusted for multiple comparisons. | Mean Difference (Final Values) | -0.06 | 2-Sided | 95 | -0.92 | 0.80 | Superiority |
| Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied. | Mixed Models Analysis | Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females) | 0.195 | The P-values were not adjusted for multiple comparisons. | Mean Difference (Final Values) | -0.58 | 2-Sided | 95 | -1.46 | 0.30 | Superiority |
| Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied. | Mixed Models Analysis | Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females) | 0.242 | The P-values were not adjusted for multiple comparisons. | Mean Difference (Final Values) | -0.52 | 2-Sided | 95 | -1.40 | 0.36 | Superiority |
| Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied. | Mixed Models Analysis | Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females) | 0.492 | The P-values were not adjusted for multiple comparisons. | Mean Difference (Final Values) | -0.33 | 2-Sided | 95 | -1.30 | 0.63 | Superiority |
| Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied. | Mixed Models Analysis | Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females) | 0.828 | The P-values were not adjusted for multiple comparisons. | Mean Difference (Final Values) | -0.11 | 2-Sided | 95 | -1.07 | 0.86 | Superiority |
| Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied. | Mixed Models Analysis | Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females) | 0.744 | The P-values were not adjusted for multiple comparisons. | Mean Difference (Final Values) | 0.16 | 2-Sided | 95 | -0.81 | 1.13 | Superiority |
| Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied. | Mixed Models Analysis | Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females) | 0.208 | The P-values were not adjusted for multiple comparisons. | Mean Difference (Final Values) | -0.63 | 2-Sided | 95 | -1.62 | 0.36 | Superiority |
| Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied. | Mixed Models Analysis | Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females) | 0.116 | The P-values were not adjusted for multiple comparisons. | Mean Difference (Final Values) | -0.79 | 2-Sided | 95 | -1.77 | 0.20 | Superiority |
| Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied. | Mixed Models Analysis | Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females) | 0.556 | The P-values were not adjusted for multiple comparisons. | Mean Difference (Final Values) | -0.25 | 2-Sided | 95 | -1.10 | 0.60 | Superiority |
| Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied. | Mixed Models Analysis | Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females) | 0.399 | The P-values were not adjusted for multiple comparisons. | Mean Difference (Final Values) | -0.36 | 2-Sided | 95 | -1.21 | 0.49 | Superiority |
| Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied. | Mixed Models Analysis | Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females) | 0.198 | The P-values were not adjusted for multiple comparisons. | Mean Difference (Final Values) | 0.55 | 2-Sided | 95 | -0.30 | 1.41 | Superiority |
| Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied. | Mixed Models Analysis | Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females) | 0.365 | The P-values were not adjusted for multiple comparisons. | Mean Difference (Final Values) | -0.40 | 2-Sided | 95 | -1.27 | 0.48 | Superiority |
| Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied. | Mixed Models Analysis | Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females) | 0.033 | The P-values were not adjusted for multiple comparisons. | Mean Difference (Final Values) | -0.95 | 2-Sided | 95 | -1.82 | -0.08 | Superiority |
| Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied. | Mixed Models Analysis | Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females) | 0.478 | The P-values were not adjusted for multiple comparisons. | Mean Difference (Final Values) | -0.32 | 2-Sided | 95 | -1.21 | 0.57 | Superiority |
| Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied. | Mixed Models Analysis | Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females) | 0.391 | The P-values were not adjusted for multiple comparisons. | Mean Difference (Final Values) | -0.38 | 2-Sided | 95 | -1.27 | 0.51 | Superiority |
| Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied. | Mixed Models Analysis | Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females) | 0.657 | The P-values were not adjusted for multiple comparisons. | Mean Difference (Final Values) | 0.20 | 2-Sided | 95 | -0.69 | 1.09 | Superiority |
| Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied. | Mixed Models Analysis | Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females) | 0.125 | The P-values were not adjusted for multiple comparisons. | Mean Difference (Final Values) | -0.71 | 2-Sided | 95 | -1.62 | 0.20 | Superiority |
| Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied. | Mixed Models Analysis | Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females) | 0.051 | The P-values were not adjusted for multiple comparisons. | Mean Difference (Final Values) | -0.91 | 2-Sided | 95 | -1.81 | 0.00 | Superiority |
| Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied. | Mixed Models Analysis | Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females) | 0.351 | The P-values were not adjusted for multiple comparisons. | Mean Difference (Final Values) | -0.42 | 2-Sided | 95 | -1.31 | 0.47 | Superiority |
| Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied. | Mixed Models Analysis | Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females) | 0.278 | The P-values were not adjusted for multiple comparisons. | Mean Difference (Final Values) | -0.49 | 2-Sided | 95 | -1.38 | 0.40 | Superiority |
| Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied. | Mixed Models Analysis | Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females) | 0.711 | The P-values were not adjusted for multiple comparisons. | Mean Difference (Final Values) | 0.17 | 2-Sided | 95 | -0.73 | 1.06 | Superiority |
| Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied. | Mixed Models Analysis | Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females) | 0.024 | The P-values were not adjusted for multiple comparisons. | Mean Difference (Final Values) | -1.06 | 2-Sided | 95 | -1.97 | -0.15 | Superiority |
| Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied. | Mixed Models Analysis | Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females) | 0.009 | The P-values were not adjusted for multiple comparisons. | Mean Difference (Final Values) | -1.23 | 2-Sided | 95 | -2.14 | -0.31 | Superiority |