Study Investigating the Impact Burden of Nocturia Using the Nocturia Impact Diary (IMPACT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01552343
First received: March 5, 2012
Last updated: May 31, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Nocturia
Drug: Desmopressin
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Placebo-controlled Study Investigating the Impact Burden of Nocturia Using the Nocturia Impact Diary

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Correlation coefficients will be estimated between change from Baseline to Month 1 in nocturnal voids and NI total score [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Difference in mean change in NI total score in 33% responders [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Effect size/NI diary responsiveness [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Responsiveness of the NI diary, measured with Cohen´s D.

  • Internal Consistency and Intra-and-Inter-subject Reliability [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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.

  • Construct Validity [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    T-tests will be applied to explore the construct validity of the NI diary.


Secondary Outcome Measures:
  • Incidence of hyponatraemia as measured by serum sodium level [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Enrollment: 56
Study Start Date: March 2012
Study Completion Date: June 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
Other Names:
  • FE992026
  • MINIRIN®
  • Nocturin®
Placebo Comparator: 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.
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.
Experimental: 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.
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.
Other Names:
  • FE992026
  • MINIRIN®
  • Nocturin®
Placebo Comparator: 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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01552343

Locations
United States, Florida
South Florida Medical Research
Aventura, Florida, United States
Avail Clinical Research, LLC
DeLand, Florida, United States
United States, Illinois
Accelovance
Peoria, Illinois, United States
United States, Massachusetts
DM Clinical Research
Springfield, Massachusetts, United States
United States, Michigan
Beyer Research
Kalamazoo, Michigan, United States
Remedica LLC
Rochester, Michigan, United States
United States, New York
Accumed Research Associates
Garden City, New York, United States
United States, South Carolina
Radiant Research, Inc.
Greer, South Carolina, United States
United States, Texas
Radiant Research, Inc.
San Antonio, Texas, United States
Quality Research, Inc.
San Antonio, Texas, United States
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01552343     History of Changes
Other Study ID Numbers: 000034
Study First Received: March 5, 2012
Last Updated: May 31, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Nocturia
Urological Manifestations
Signs and Symptoms
Deamino Arginine Vasopressin
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 17, 2014