Clinical trial NCT01552343: Study Investigating the Impact Burden of Nocturia Using the Nocturia Impact Diary
Official title: A Double-blind, Randomized, Placebo-controlled Study Investigating the Impact Burden of Nocturia Using the Nocturia Impact Diary
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nocturia
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2012-03-13
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Day 1 (Baseline), Month 1
measure: Difference in Mean Change From Baseline to Month 1 in Nocturia Impact (NI) Total Scores and Overall Impact Question for Responders and Non-Responders
timeFrame: Day 1 (Baseline), Month 1
measure: 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
timeFrame: Day 1 (Baseline), Month 1
Secondary outcomes:
measure: Internal Consistency of the Nocturia Impact (NI) Total Score for Each Day NI Diaries Were Completed Assessed as Cronbach's Alpha Values
timeFrame: Screening (Day -20 to Day -18), Baseline (Day -2 to Day 1) and Treatment (Day 28 to Day 30)
measure: Construct Validity For the Nocturia Impact (NI) Total Scores and Overall Impact Question (Q12) for Participants With High/Low Number of Nocturnal Voids
timeFrame: Screening (Day -20), Baseline (Day 1)
measure: Change From Baseline to Month 1 on Nocturia Impact (NI) Total Score
timeFrame: Baseline (Day -2 to Day 1), Treatment (Day 28-30)
measure: Minimum Post-Treatment Serum Sodium Levels
timeFrame: Day 1 up to 1 month
measure: Summary of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Day 1 up to 1 month
Other outcomes:
Locations:
city: Aventura
country: United States
facility: South Florida Medical Research
state: Florida
city: DeLand
country: United States
facility: Avail Clinical Research, LLC
state: Florida
city: Peoria
country: United States
facility: Accelovance
state: Illinois
city: Springfield
country: United States
facility: DM Clinical Research
state: Massachusetts
city: Kalamazoo
country: United States
facility: Beyer Research
state: Michigan
city: Rochester
country: United States
facility: Remedica LLC
state: Michigan
city: Garden City
country: United States
facility: Accumed Research Associates
state: New York
city: Greer
country: United States
facility: Radiant Research, Inc.
state: South Carolina
city: San Antonio
country: United States
facility: Quality Research, Inc.
state: Texas
city: San Antonio
country: United States
facility: Radiant Research, Inc.
state: Texas
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References:
citation: Holm-Larsen T, Andersson F, van der Meulen E, Yankov V, Rosen RC, Norgaard JP. The Nocturia Impact Diary: a self-reported impact measure to complement the voiding diary. Value Health. 2014 Sep;17(6):696-706. doi: 10.1016/j.jval.2014.06.007. Epub 2014 Aug 20.