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

NCT ID: NCT01552343

Last Updated: 2017-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2012-06-30

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.

Conditions

Nocturia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Female - Desmopressin 25 μg

Female participants took 1 tablet of 25 μg every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.

Group Type: EXPERIMENTAL

Desmopressin

Intervention Type: DRUG

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.

Female - Placebo

Female 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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Male - Desmopressin 75 μg

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.

Group Type: EXPERIMENTAL

Desmopressin

Intervention Type: DRUG

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.

Male - Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

FE992026; MINIRIN®; Nocturin®

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ferring Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Development Support

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

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

Countries

United States

References

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.

Reference Type: RESULT

PMID: 25236993 (View on PubMed)

Other Identifiers

000034

Identifier Type: -

Identifier Source: org_study_id