Study Investigating the Impact Burden of Nocturia Using the Nocturia Impact Diary
Information source: Ferring Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Nocturia
Intervention: Desmopressin (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Ferring Pharmaceuticals Official(s) and/or principal investigator(s): Clinical Development Support, Study Director, Affiliation: Ferring Pharmaceuticals
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.
Clinical Details
Official title: A Double-blind, Randomized, Placebo-controlled Study Investigating the Impact Burden of Nocturia Using the Nocturia Impact Diary
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Correlation coefficients will be estimated between change from Baseline to Month 1 in nocturnal voids and NI total scoreDifference in mean change in NI total score in 33% responders Effect size/NI diary responsiveness Internal Consistency and Intra-and-Inter-subject Reliability Construct Validity
Secondary outcome: Incidence of hyponatraemia as measured by serum sodium level
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
South Florida Medical Research, Aventura, Florida, United States
Avail Clinical Research, LLC, DeLand, Florida, United States
Accelovance, Peoria, Illinois, United States
DM Clinical Research, Springfield, Massachusetts, United States
Beyer Research, Kalamazoo, Michigan, United States
Remedica LLC, Rochester, Michigan, United States
Accumed Research Associates, Garden City, New York, United States
Radiant Research, Inc., Greer, South Carolina, United States
Quality Research, Inc., San Antonio, Texas, United States
Radiant Research, Inc., San Antonio, Texas, United States
Additional Information
Starting date: March 2012
Last updated: May 31, 2013
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