Nocturia
Conditions
Brief summary
The purpose of this study is to assess psychometric properties (reliability and validity) of the Nocturia Impact (NI) diary. To assess the association between reduction of number of nocturnal voids and the mean changes in NI scores (sensitivity of the NI total score to change in nocturia). To assess which NI diary items account for the main difference in change in total NI score in treatment versus placebo.
Interventions
DRUGDesmopressin
Desmopressin orally disintegrating tablets. Female participants took a 25 μg tablet and male participants took a 75 μg tablet one hour prior to bedtime for one month.
DRUGPlacebo
Placebo to match the 25 μg tablet of active drug taken by female participants or the 75 μg tablet taken by males. One placebo tablet taken one hour prior to bedtime for one month.
Sponsors
Ferring Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Written informed consent prior to performance of any study-related activity 2. 18 years of age (at the time of written consent) or older 3. Previous participation in FE992026 CS40 or FE992026 CS41 with a completion ≥ 30 days prior to Screening. The subject should have responded to active treatment during FE992026 CS40 or FE992026 CS41 or if he/she received placebo during these two studies he/she should have been a non-responder. 4. At least two nocturnal voids every night in two consecutive 3-day periods during the screening period (as determined by the two night-time voiding diaries dispensed at Visit 1 and collected at Visit 2)
Exclusion criteria
1. Chronic prostatitis (males)/chronic pelvic pain syndrome (CPPS) 2. Suspicion of bladder outlet obstruction (BOO) or a urine flow of \< 5 mL/s as confirmed by uroflowmetry performed after suspicion of BOO 3. Surgical treatment, including transurethral resection, for BOO or benign prostatic hyperplasia (males) within the past six months 4. Urinary retention or a post void residual volume \> 150 mL for females and \> 250 mL for males as confirmed by bladder ultrasound performed after suspicion of urinary retention 5. Central or nephrogenic diabetes insipidus 6. Syndrome of inappropriate antidiuretic hormone 7. Current or a history of urologic malignancies e.g. bladder cancer 8. Genito-urinary tract pathology e.g. infection or stone in the bladder and urethra causing symptoms 9. Neurogenic detrusor activity (detrusor overactivity) 10. Suspicion or evidence of cardiac failure 11. Chronic prostatitis (males)/chronic pelvic pain syndrome (CPPS) 12. Uncontrolled hypertension 13. Uncontrolled diabetes mellitus 14. Hyponatraemia: serum sodium level must be within normal limits 15. Renal insufficiency: Serum creatinine must be within normal limits and estimated glomerular filtration rate must be ≥ 50 mL/min 16. Hepatic and/or biliary diseases: Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) levels must not be more than twice the upper limit of normal range. Total bilirubin level must not be \> 1.5 mg/dL 17. History of obstructive sleep apnea 18. Treatment with another investigational product (except desmopressin) within three months prior to screening and throughout the study 19. Concomitant treatment with loop diuretics (furosemide, torsemide, ethacrynic acid) 20. Pregnancy, breastfeeding, or an intention of becoming pregnant during the period of the clinical study. Female subjects of reproductive age must have documentation of a reliable method of contraception. All pre-and perimenopausal female subjects have to perform pregnancy tests. Amenorrhea of \> 12 months duration based on the reported date of the last menstrual period is sufficient documentation of post-menopausal status and does not require a pregnancy test 21. Known alcohol or substance abuse 22. Work or lifestyle that may interfere with regular night-time sleep e.g. shiftworkers 23. Any other medical condition, laboratory abnormality, psychiatric condition, mental incapacity, or language barrier which, in the judgment of the Investigator, would impair participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Pearson Correlation Coefficient Between Change From Baseline to Month 1 in Number of Nocturnal Voids and Change From Baseline to Month 1 in Nocturia Impact (NI) Diary Total Score | Day 1 (Baseline), Month 1 | This outcome is a measure of sensitivity of the NI Diary to change in nocturia. The NI Diary is a 12-item instrument consisting of 11 core items and an overall impact question (Q12). Responses are scored from 0 (no impact) to 4 (highest impact); a lowering of score equals a decrease in impact caused by nocturia. The NI total score is the sum of the 11 core items scores. The NI total score was analyzable only if all 11 items (Q1-Q11) had non-missing responses. Otherwise, it was defined as missing. Missing values were not imputed. The average over the 3-day diary period prior to baseline (Day 1) and Month 1 was used for the overall impact score. The correlation was estimated using Fisher's z transformation, i.e. the NI total score was based on a standardized scale from 0 (lowest impact) to 100 (highest impact). Corresponding adjusted partial correlation coefficients were based on adjustments for mean number of Baseline voids, Baseline NI total score, age, and gender. |
| Difference in Mean Change From Baseline to Month 1 in Nocturia Impact (NI) Total Scores and Overall Impact Question for Responders and Non-Responders | Day 1 (Baseline), Month 1 | This outcome is a measure of sensitivity of the NI Diary to change in nocturia. The NI Diary is a 12-item instrument consisting of 11 core items and an overall impact question (Q12). The NI total score is defined as the sum of the 11 core items scores. The overall impact question (Q12) and the NI total score were transformed using Fisher's z transformation, i.e. the scores were based on a standardized scale from 0 (lowest impact) to 100 (highest impact). The difference in mean change in NI total score for subjects who experienced a reduction from baseline of \<33% in nocturnal voids at the Month 1 visit (non-responders) versus those with a reduction in nocturnal voids from Baseline of ≥33% (responders) was estimated. |
| Cohen's D Effect Size in Responsiveness in the Nocturia Impact (NI) Total Scores and Overall Impact Question as Measured From Baseline (Day 1) to Month 1 | Day 1 (Baseline), Month 1 | The responsiveness of the NI Diary was measured with Cohen's D effect size. The effect size was calculated for active treatment versus placebo, based on change from Baseline to Month 1. The effect size was evaluated as small, medium, or large if D was \<=0.35, \>0.35 - 0.65, or \>0.65, respectively. Mean values are the Cohen's D effect size. Standard deviation is the pooled standard deviation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Minimum Post-Treatment Serum Sodium Levels | Day 1 up to 1 month | Serum sodium levels were monitored since hyponatremia is a potential serious adverse event associated with daily doses of desmopressin. A participant was to be withdrawn from the trial if the serum sodium level was \<=125 mmol/L at any time. |
| Internal Consistency of the Nocturia Impact (NI) Total Score for Each Day NI Diaries Were Completed Assessed as Cronbach's Alpha Values | Screening (Day -20 to Day -18), Baseline (Day -2 to Day 1) and Treatment (Day 28 to Day 30) | Cronbach's alpha (CA) is a measure of the internal consistency of the Nocturia Impact (NI) Total scores. Higher scores indicate a more reliable (precise) instrument. A value of 0.70 set as the benchmark for declaring the scale as internally consistent. Cronbach's alpha was assessed for each of the three consecutive days NI diaries were completed during screening (Day -20 to Day -18), baseline (Day -2 to Day 1) and Month 1 (Day 28 to Day 30). |
| Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) | Day 1 up to 1 month | A TEAE was any adverse event occurring after start of treatment and within the time of residual drug effect, i.e. within one day of the last dose of desmopressin. |
| Construct Validity For the Nocturia Impact (NI) Total Scores and Overall Impact Question (Q12) for Participants With High/Low Number of Nocturnal Voids | Screening (Day -20), Baseline (Day 1) | The known group validity was assessed by comparing participants who experienced ≥3 nocturnal voids to those who experienced \<3 nocturnal voids, using the average over 3 days for the Screening and Baseline diaries. Results are reported for the NI Total Scores and the Overall Impact Question (Q12). The NI Diary is a 12-item instrument consisting of 11 core items and an overall impact question (Q12). The NI total score is defined as the sum of the 11 core items scores. The overall impact question (Q12) and the NI total score were transformed using Fisher's z transformation, i.e. the scores were based on a standardized scale from 0 (lowest impact) to 100 (highest impact). |
| Change From Baseline to Month 1 on Nocturia Impact (NI) Total Score | Baseline (Day -2 to Day 1), Treatment (Day 28-30) | The NI Diary is a 12-item instrument consisting of 11 core items and an overall impact question (Q12). Responses are scored from 0 (no impact) to 4 (highest impact); the NI total score is the sum of the 11 core items scores (range of 0-44) which is then transformed to a 0-100 scale (high score indicates high impact). The NI total score was analyzable only if all 11 items (Q1-Q11) had non-missing responses. Otherwise, it was defined as missing. Missing values were not imputed. The average over the 3-day diary period prior to baseline (Day 1) and Month 1 was used for the overall impact score. Negative change from baseline scores indicate a decrease in impact caused by nocturia. |
Countries
United States
Participant flow
Pre-assignment details
A total of 67 subjects were screened and 11 subjects were screening failures: 5 due to signs of renal impairment, 4 did not have \>=2 nocturnal voids every night in the 3-day screening period, 1 had uncontrolled diabetes mellitus, and 1 was leaving town for an undetermined period of time.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Female and male participants took 1 tablet of placebo every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month. | 29 |
| Desmopressin Female participants took 1 desmopressin 25 μg tablet and male participants took 1 tablet 75 μg every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month. | 27 |
| Total | 56 |
Baseline characteristics
| Characteristic | Placebo | Desmopressin | Total |
|---|---|---|---|
| Age, Customized < 65 years | 11 participants | 13 participants | 24 participants |
| Age, Customized >=65 years | 18 participants | 14 participants | 32 participants |
| Ethnic Origin Hispanic or Latino | 6 participants | 2 participants | 8 participants |
| Ethnic Origin Not Hispanic or Latino | 23 participants | 25 participants | 48 participants |
| Race/Ethnicity, Customized American Indian/Alaska native | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Asian | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Black/African American | 4 participants | 2 participants | 6 participants |
| Race/Ethnicity, Customized White | 25 participants | 23 participants | 48 participants |
| Sex: Female, Male Female | 14 Participants | 12 Participants | 26 Participants |
| Sex: Female, Male Male | 15 Participants | 15 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 29 | 0 / 27 |
| serious Total, serious adverse events | 0 / 29 | 0 / 27 |
Outcome results
Primary
Cohen's D Effect Size in Responsiveness in the Nocturia Impact (NI) Total Scores and Overall Impact Question as Measured From Baseline (Day 1) to Month 1
The responsiveness of the NI Diary was measured with Cohen's D effect size. The effect size was calculated for active treatment versus placebo, based on change from Baseline to Month 1. The effect size was evaluated as small, medium, or large if D was \<=0.35, \>0.35 - 0.65, or \>0.65, respectively. Mean values are the Cohen's D effect size. Standard deviation is the pooled standard deviation.
Time frame: Day 1 (Baseline), Month 1
Population: Full analysis set. Study results are reported as per the pre-planned statistical analysis plan on combined treatment groups. The study is a psychometric evaluation of a new PRO tool and is not designed to show treatment difference between active and placebo.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Cohen's D Effect Size in Responsiveness in the Nocturia Impact (NI) Total Scores and Overall Impact Question as Measured From Baseline (Day 1) to Month 1 | Nocturia Impact (NI) Total Score (Q1-Q11) | 0.73 units on a scale | Standard Deviation 14.7 |
| All Participants | Cohen's D Effect Size in Responsiveness in the Nocturia Impact (NI) Total Scores and Overall Impact Question as Measured From Baseline (Day 1) to Month 1 | Overall Impact Question (Q12) | -0.00 units on a scale | Standard Deviation 17.5 |
Primary
Difference in Mean Change From Baseline to Month 1 in Nocturia Impact (NI) Total Scores and Overall Impact Question for Responders and Non-Responders
This outcome is a measure of sensitivity of the NI Diary to change in nocturia. The NI Diary is a 12-item instrument consisting of 11 core items and an overall impact question (Q12). The NI total score is defined as the sum of the 11 core items scores. The overall impact question (Q12) and the NI total score were transformed using Fisher's z transformation, i.e. the scores were based on a standardized scale from 0 (lowest impact) to 100 (highest impact). The difference in mean change in NI total score for subjects who experienced a reduction from baseline of \<33% in nocturnal voids at the Month 1 visit (non-responders) versus those with a reduction in nocturnal voids from Baseline of ≥33% (responders) was estimated.
Time frame: Day 1 (Baseline), Month 1
Population: Full analysis set. Study results are reported as per the pre-planned statistical analysis plan on combined treatment groups. The study is a psychometric evaluation of a new PRO tool and is not designed to show treatment difference between active and placebo.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Difference in Mean Change From Baseline to Month 1 in Nocturia Impact (NI) Total Scores and Overall Impact Question for Responders and Non-Responders | Nocturia Impact (NI) Total Score (Q1-Q11) | -2.6 units on a scale | Standard Deviation 6.8 |
| All Participants | Difference in Mean Change From Baseline to Month 1 in Nocturia Impact (NI) Total Scores and Overall Impact Question for Responders and Non-Responders | Overall Impact Question (Q12) | -4.9 units on a scale | Standard Deviation 15.6 |
| Responders | Difference in Mean Change From Baseline to Month 1 in Nocturia Impact (NI) Total Scores and Overall Impact Question for Responders and Non-Responders | Nocturia Impact (NI) Total Score (Q1-Q11) | -13.3 units on a scale | Standard Deviation 17.9 |
| Responders | Difference in Mean Change From Baseline to Month 1 in Nocturia Impact (NI) Total Scores and Overall Impact Question for Responders and Non-Responders | Overall Impact Question (Q12) | -4.9 units on a scale | Standard Deviation 18.6 |
Comparison: Nocturia Impact (NI) Total Score (Q1-Q11)95% CI: [2.7, 18.8]
Comparison: Overall Impact Question (Q12)95% CI: [-9.6, 9.6]
Primary
The Pearson Correlation Coefficient Between Change From Baseline to Month 1 in Number of Nocturnal Voids and Change From Baseline to Month 1 in Nocturia Impact (NI) Diary Total Score
This outcome is a measure of sensitivity of the NI Diary to change in nocturia. The NI Diary is a 12-item instrument consisting of 11 core items and an overall impact question (Q12). Responses are scored from 0 (no impact) to 4 (highest impact); a lowering of score equals a decrease in impact caused by nocturia. The NI total score is the sum of the 11 core items scores. The NI total score was analyzable only if all 11 items (Q1-Q11) had non-missing responses. Otherwise, it was defined as missing. Missing values were not imputed. The average over the 3-day diary period prior to baseline (Day 1) and Month 1 was used for the overall impact score. The correlation was estimated using Fisher's z transformation, i.e. the NI total score was based on a standardized scale from 0 (lowest impact) to 100 (highest impact). Corresponding adjusted partial correlation coefficients were based on adjustments for mean number of Baseline voids, Baseline NI total score, age, and gender.
Time frame: Day 1 (Baseline), Month 1
Population: Full analysis set. Study results are reported as per the pre-planned statistical analysis plan on combined treatment groups. The study is a psychometric evaluation of a new PRO tool and is not designed to show treatment difference between active and placebo.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | The Pearson Correlation Coefficient Between Change From Baseline to Month 1 in Number of Nocturnal Voids and Change From Baseline to Month 1 in Nocturia Impact (NI) Diary Total Score | Correlation - no adjustments | 0.31 correlation coefficient |
| All Participants | The Pearson Correlation Coefficient Between Change From Baseline to Month 1 in Number of Nocturnal Voids and Change From Baseline to Month 1 in Nocturia Impact (NI) Diary Total Score | Adjusted partial correlation - baseline # of voids | 0.35 correlation coefficient |
| All Participants | The Pearson Correlation Coefficient Between Change From Baseline to Month 1 in Number of Nocturnal Voids and Change From Baseline to Month 1 in Nocturia Impact (NI) Diary Total Score | Adj partial correlation - baseline NI total score | 0.28 correlation coefficient |
| All Participants | The Pearson Correlation Coefficient Between Change From Baseline to Month 1 in Number of Nocturnal Voids and Change From Baseline to Month 1 in Nocturia Impact (NI) Diary Total Score | Adjusted partial correlation - age category | 0.33 correlation coefficient |
| All Participants | The Pearson Correlation Coefficient Between Change From Baseline to Month 1 in Number of Nocturnal Voids and Change From Baseline to Month 1 in Nocturia Impact (NI) Diary Total Score | Adjusted partial correlation - gender | 0.33 correlation coefficient |
Comparison: Correlation - no adjustmentsp-value: 0.0187t-test, 2 sided
Comparison: Partial correlation - baseline # of voidsp-value: 0.0094t-test, 2 sided
Comparison: Partial correlation - baseline NI total scorep-value: 0.0383t-test, 2 sided
Comparison: Partial correlation - age categoryp-value: 0.0133t-test, 2 sided
Comparison: Partial correlation - genderp-value: 0.0128t-test, 2 sided
Secondary
Change From Baseline to Month 1 on Nocturia Impact (NI) Total Score
The NI Diary is a 12-item instrument consisting of 11 core items and an overall impact question (Q12). Responses are scored from 0 (no impact) to 4 (highest impact); the NI total score is the sum of the 11 core items scores (range of 0-44) which is then transformed to a 0-100 scale (high score indicates high impact). The NI total score was analyzable only if all 11 items (Q1-Q11) had non-missing responses. Otherwise, it was defined as missing. Missing values were not imputed. The average over the 3-day diary period prior to baseline (Day 1) and Month 1 was used for the overall impact score. Negative change from baseline scores indicate a decrease in impact caused by nocturia.
Time frame: Baseline (Day -2 to Day 1), Treatment (Day 28-30)
Population: Full analysis set. The study is a psychometric evaluation of a new PRO tool and is not designed to show treatment difference between active and placebo.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Change From Baseline to Month 1 on Nocturia Impact (NI) Total Score | -8.5 units on a scale | Standard Deviation 13.7 |
| Responders | Change From Baseline to Month 1 on Nocturia Impact (NI) Total Score | -9.64 units on a scale | Standard Deviation 17.2 |
Comparison: Treatment effect. NI total scores are transformed to a 0-100 scale where 0 is good and 100 bad.p-value: 0.964795% CI: [-6.6, 6.3]ANCOVA
Secondary
Construct Validity For the Nocturia Impact (NI) Total Scores and Overall Impact Question (Q12) for Participants With High/Low Number of Nocturnal Voids
The known group validity was assessed by comparing participants who experienced ≥3 nocturnal voids to those who experienced \<3 nocturnal voids, using the average over 3 days for the Screening and Baseline diaries. Results are reported for the NI Total Scores and the Overall Impact Question (Q12). The NI Diary is a 12-item instrument consisting of 11 core items and an overall impact question (Q12). The NI total score is defined as the sum of the 11 core items scores. The overall impact question (Q12) and the NI total score were transformed using Fisher's z transformation, i.e. the scores were based on a standardized scale from 0 (lowest impact) to 100 (highest impact).
Time frame: Screening (Day -20), Baseline (Day 1)
Population: Full analysis set. Study results are reported as per the pre-planned statistical analysis plan on combined treatment groups. The study is a psychometric evaluation of a new PRO tool and is not designed to show treatment difference between active and placebo.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Construct Validity For the Nocturia Impact (NI) Total Scores and Overall Impact Question (Q12) for Participants With High/Low Number of Nocturnal Voids | Nocturia Impact (NI) Total Score: Screening | 28.1 units on a scale | Standard Deviation 20.4 |
| All Participants | Construct Validity For the Nocturia Impact (NI) Total Scores and Overall Impact Question (Q12) for Participants With High/Low Number of Nocturnal Voids | Nocturia Impact (NI) Total Score: Baseline | 25.7 units on a scale | Standard Deviation 20.4 |
| All Participants | Construct Validity For the Nocturia Impact (NI) Total Scores and Overall Impact Question (Q12) for Participants With High/Low Number of Nocturnal Voids | Overall Impact Question (Q12): Screening | 40.4 units on a scale | Standard Deviation 27.3 |
| All Participants | Construct Validity For the Nocturia Impact (NI) Total Scores and Overall Impact Question (Q12) for Participants With High/Low Number of Nocturnal Voids | Overall Impact Question (Q12): Baseline | 35.6 units on a scale | Standard Deviation 28.4 |
| Responders | Construct Validity For the Nocturia Impact (NI) Total Scores and Overall Impact Question (Q12) for Participants With High/Low Number of Nocturnal Voids | Overall Impact Question (Q12): Baseline | 53.3 units on a scale | Standard Deviation 34.7 |
| Responders | Construct Validity For the Nocturia Impact (NI) Total Scores and Overall Impact Question (Q12) for Participants With High/Low Number of Nocturnal Voids | Nocturia Impact (NI) Total Score: Screening | 36.7 units on a scale | Standard Deviation 23 |
| Responders | Construct Validity For the Nocturia Impact (NI) Total Scores and Overall Impact Question (Q12) for Participants With High/Low Number of Nocturnal Voids | Overall Impact Question (Q12): Screening | 56.2 units on a scale | Standard Deviation 30.1 |
| Responders | Construct Validity For the Nocturia Impact (NI) Total Scores and Overall Impact Question (Q12) for Participants With High/Low Number of Nocturnal Voids | Nocturia Impact (NI) Total Score: Baseline | 39.3 units on a scale | Standard Deviation 25.7 |
Comparison: Nocturia Impact (NI) Total Score: Screeningp-value: 0.147195% CI: [-20.3, 3.1]t-test, 2 sided
Comparison: Nocturia Impact (NI) Total Score: Baselinep-value: 0.031895% CI: [-26, -1.2]t-test, 2 sided
Comparison: Overall Impact Question (Q12): Screeningp-value: 0.046395% CI: [-31.2, -0.3]t-test, 2 sided
Comparison: Overall Impact Question (Q12): Baselinep-value: 0.041395% CI: [-34.6, -0.7]t-test, 2 sided
Secondary
Internal Consistency of the Nocturia Impact (NI) Total Score for Each Day NI Diaries Were Completed Assessed as Cronbach's Alpha Values
Cronbach's alpha (CA) is a measure of the internal consistency of the Nocturia Impact (NI) Total scores. Higher scores indicate a more reliable (precise) instrument. A value of 0.70 set as the benchmark for declaring the scale as internally consistent. Cronbach's alpha was assessed for each of the three consecutive days NI diaries were completed during screening (Day -20 to Day -18), baseline (Day -2 to Day 1) and Month 1 (Day 28 to Day 30).
Time frame: Screening (Day -20 to Day -18), Baseline (Day -2 to Day 1) and Treatment (Day 28 to Day 30)
Population: Full analysis set. Study results are reported as per the pre-planned statistical analysis plan on combined treatment groups. The study is a psychometric evaluation of a new PRO tool and is not designed to show treatment difference between active and placebo.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Internal Consistency of the Nocturia Impact (NI) Total Score for Each Day NI Diaries Were Completed Assessed as Cronbach's Alpha Values | Baseline Day -1 | 0.941 ratio of variance |
| All Participants | Internal Consistency of the Nocturia Impact (NI) Total Score for Each Day NI Diaries Were Completed Assessed as Cronbach's Alpha Values | Screening Day -20 | 0.915 ratio of variance |
| All Participants | Internal Consistency of the Nocturia Impact (NI) Total Score for Each Day NI Diaries Were Completed Assessed as Cronbach's Alpha Values | Screening Day -19 | 0.925 ratio of variance |
| All Participants | Internal Consistency of the Nocturia Impact (NI) Total Score for Each Day NI Diaries Were Completed Assessed as Cronbach's Alpha Values | Screening Day -18 | 0.923 ratio of variance |
| All Participants | Internal Consistency of the Nocturia Impact (NI) Total Score for Each Day NI Diaries Were Completed Assessed as Cronbach's Alpha Values | Baseline Day -2 | 0.939 ratio of variance |
| All Participants | Internal Consistency of the Nocturia Impact (NI) Total Score for Each Day NI Diaries Were Completed Assessed as Cronbach's Alpha Values | Baseline Day 1 | 0.943 ratio of variance |
| All Participants | Internal Consistency of the Nocturia Impact (NI) Total Score for Each Day NI Diaries Were Completed Assessed as Cronbach's Alpha Values | Treatment Day 28 | 0.920 ratio of variance |
| All Participants | Internal Consistency of the Nocturia Impact (NI) Total Score for Each Day NI Diaries Were Completed Assessed as Cronbach's Alpha Values | Treatment Day 29 | 0.914 ratio of variance |
| All Participants | Internal Consistency of the Nocturia Impact (NI) Total Score for Each Day NI Diaries Were Completed Assessed as Cronbach's Alpha Values | Treatment Day 30 | 0.898 ratio of variance |
Secondary
Minimum Post-Treatment Serum Sodium Levels
Serum sodium levels were monitored since hyponatremia is a potential serious adverse event associated with daily doses of desmopressin. A participant was to be withdrawn from the trial if the serum sodium level was \<=125 mmol/L at any time.
Time frame: Day 1 up to 1 month
Population: Safety analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Minimum Post-Treatment Serum Sodium Levels | <=125 mmol/L | 0 participants |
| All Participants | Minimum Post-Treatment Serum Sodium Levels | >=130 - 135 mmol/L | 0 participants |
| All Participants | Minimum Post-Treatment Serum Sodium Levels | >125 - <130 mmol/L | 0 participants |
| Responders | Minimum Post-Treatment Serum Sodium Levels | <=125 mmol/L | 0 participants |
| Responders | Minimum Post-Treatment Serum Sodium Levels | >=130 - 135 mmol/L | 0 participants |
| Responders | Minimum Post-Treatment Serum Sodium Levels | >125 - <130 mmol/L | 0 participants |
| Female - Desmopressin 25 μg | Minimum Post-Treatment Serum Sodium Levels | >125 - <130 mmol/L | 0 participants |
| Female - Desmopressin 25 μg | Minimum Post-Treatment Serum Sodium Levels | <=125 mmol/L | 0 participants |
| Female - Desmopressin 25 μg | Minimum Post-Treatment Serum Sodium Levels | >=130 - 135 mmol/L | 2 participants |
| Male - Desmopressin 75 μg | Minimum Post-Treatment Serum Sodium Levels | <=125 mmol/L | 0 participants |
| Male - Desmopressin 75 μg | Minimum Post-Treatment Serum Sodium Levels | >=130 - 135 mmol/L | 1 participants |
| Male - Desmopressin 75 μg | Minimum Post-Treatment Serum Sodium Levels | >125 - <130 mmol/L | 0 participants |
Secondary
Summary of Participants With Treatment-Emergent Adverse Events (TEAEs)
A TEAE was any adverse event occurring after start of treatment and within the time of residual drug effect, i.e. within one day of the last dose of desmopressin.
Time frame: Day 1 up to 1 month
Population: Safety analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) | All adverse events (AEs) | 2 participants |
| All Participants | Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) | Deaths | 0 participants |
| All Participants | Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) | Serious AEs | 0 participants |
| All Participants | Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) | AEs leading to discontinuation | 0 participants |
| All Participants | Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) | Severe AEs | 0 participants |
| All Participants | Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) | Adverse drug reactions (ADRs) | 0 participants |
| Responders | Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) | Adverse drug reactions (ADRs) | 0 participants |
| Responders | Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) | AEs leading to discontinuation | 0 participants |
| Responders | Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) | All adverse events (AEs) | 1 participants |
| Responders | Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) | Serious AEs | 0 participants |
| Responders | Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) | Deaths | 0 participants |
| Responders | Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) | Severe AEs | 0 participants |
| Female - Desmopressin 25 μg | Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) | Deaths | 0 participants |
| Female - Desmopressin 25 μg | Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) | Serious AEs | 0 participants |
| Female - Desmopressin 25 μg | Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) | AEs leading to discontinuation | 0 participants |
| Female - Desmopressin 25 μg | Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) | Adverse drug reactions (ADRs) | 1 participants |
| Female - Desmopressin 25 μg | Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) | Severe AEs | 0 participants |
| Female - Desmopressin 25 μg | Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) | All adverse events (AEs) | 2 participants |
| Male - Desmopressin 75 μg | Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) | Severe AEs | 0 participants |
| Male - Desmopressin 75 μg | Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) | Adverse drug reactions (ADRs) | 0 participants |
| Male - Desmopressin 75 μg | Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) | Deaths | 0 participants |
| Male - Desmopressin 75 μg | Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) | AEs leading to discontinuation | 0 participants |
| Male - Desmopressin 75 μg | Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) | All adverse events (AEs) | 0 participants |
| Male - Desmopressin 75 μg | Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) | Serious AEs | 0 participants |