Study Investigating the Impact Burden of Nocturia Using the Nocturia Impact Diary

Nocturia Clinical Trial

— IMPACT  

Official title:

A Double-blind, Randomized, Placebo-controlled Study Investigating the Impact Burden of Nocturia Using the Nocturia Impact Diary

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01552343
• Other study ID #: 000034
• Status: Completed
• Phase: Phase 3
• First received: March 5, 2012
• Last updated: May 31, 2013
• Start date: March 2012
• Est. completion date: June 2012

Study information

• Verified date: May 2013
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: June 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nocturia

Intervention

Drug:
• Desmopressin
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.
• Placebo
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.

Locations

Country	Name	City	State
United States	South Florida Medical Research	Aventura	Florida
United States	Avail Clinical Research, LLC	DeLand	Florida
United States	Accumed Research Associates	Garden City	New York
United States	Radiant Research, Inc.	Greer	South Carolina
United States	Beyer Research	Kalamazoo	Michigan
United States	Accelovance	Peoria	Illinois
United States	Remedica LLC	Rochester	Michigan
United States	Quality Research, Inc.	San Antonio	Texas
United States	Radiant Research, Inc.	San Antonio	Texas
United States	DM Clinical Research	Springfield	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation coefficients will be estimated between change from Baseline to Month 1 in nocturnal voids and NI total score		1 month	No
Primary	Difference in mean change in NI total score in 33% responders		1 month	No
Primary	Effect size/NI diary responsiveness	Responsiveness of the NI diary, measured with Cohen´s D.	1 month	No
Primary	Internal Consistency and Intra-and-Inter-subject Reliability	Internal consistency reliability, assessed by the Cronbach´s alpha for the NI total score: A repeated measures ANOVA will be applied to estimate between-and within-subject variability of the total NI score and the Overall Impact score.	1 month	No
Primary	Construct Validity	T-tests will be applied to explore the construct validity of the NI diary.	1 month	No
Secondary	Incidence of hyponatraemia as measured by serum sodium level		1 month	Yes