Phase 3
N=56
Study Investigating the Impact Burden of Nocturia Using the Nocturia Impact Diary
Nocturia
Bottom Line
View on ClinicalTrials.gov: NCT01552343 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: 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 — 0.31; 0.35; 0.28; 0.33 correlation coefficient — p=0.0187
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Desmopressin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ferring Pharmaceuticals
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
0.31; 0.35; 0.28; 0.33; 0.33 | 0.0187 sig |
| 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 |
-2.6; -13.3; -4.9; -4.9 | — |
| 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 |
0.73; -0.00 | — |
| SECONDARY Internal Consistency of the Nocturia Impact (NI) Total Score for Each Day NI Diaries Were Completed Assessed as Cronbach's Alpha Values |
0.915; 0.925; 0.923; 0.939; 0.941; 0.943 | — |
| SECONDARY Construct Validity For the Nocturia Impact (NI) Total Scores and Overall Impact Question (Q12) for Participants With High/Low Number of Nocturnal Voids |
28.1; 36.7; 25.7; 39.3; 40.4; 56.2 | 0.1471 |
| SECONDARY Change From Baseline to Month 1 on Nocturia Impact (NI) Total Score |
-8.5; -9.64 | 0.9647 |
| SECONDARY Minimum Post-Treatment Serum Sodium Levels |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) |
2; 1; 2; 0; 0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Written informed consent prior to performance of any study-related activity
- 18 years of age (at the time of written consent) or older
- 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.
- 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
- Chronic prostatitis (males)/chronic pelvic pain syndrome (CPPS)
- Suspicion of bladder outlet obstruction (BOO) or a urine flow of 150 mL for females and > 250 mL for males as confirmed by bladder ultrasound performed after suspicion of urinary retention
- Central or nephrogenic diabetes insipidus
- Syndrome of inappropriate antidiuretic hormone
- Current or a history of urologic malignancies e.g. bladder cancer
- Genito-urinary tract pathology e.g. infection or stone in the bladder and urethra causing symptoms
- Neurogenic detrusor activity (detrusor overactivity)
- Suspicion or evidence of cardiac failure
- Chronic prostatitis (males)/chronic pelvic pain syndrome (CPPS)
- Uncontrolled hypertension
- Uncontrolled diabetes mellitus
- Hyponatraemia: serum sodium level must be within normal limits
- Renal insufficiency: Serum creatinine must be within normal limits and estimated glomerular filtration rate must be ≥ 50 mL/min
- 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
- History of obstructive sleep apnea
- Treatment with another investigational product (except desmopressin) within three months prior to screening and throughout the study
- Concomitant treatment with loop diuretics (furosemide, torsemide, ethacrynic acid)
- 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
- Known alcohol or substance abuse
- 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
Data sourced from ClinicalTrials.gov (NCT01552343). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.