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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: March 27, 2017
Last verified: March 2017

March 5, 2012
March 27, 2017
March 2012
May 2012   (Final data collection date for primary outcome 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 [ Time Frame: Day 1 (Baseline), Month 1 ]

    This outcome is a measure of sensitivity of the NI Diary to change in nocturia.

    The NI Diary is a 12-item instrument consisting of 11 core items and an overall impact question (Q12). Responses are scored from 0 (no impact) to 4 (highest impact); a lowering of score equals a decrease in impact caused by nocturia. The NI total score is the sum of the 11 core items scores. The NI total score was analyzable only if all 11 items (Q1-Q11) had non-missing responses. Otherwise, it was defined as missing. Missing values were not imputed. The average over the 3-day diary period prior to baseline (Day 1) and Month 1 was used for the overall impact score.

    The correlation was estimated using Fisher's z transformation, i.e. the NI total score was based on a standardized scale from 0 (lowest impact) to 100 (highest impact).

    Corresponding adjusted partial correlation coefficients were based on adjustments for mean number of Baseline voids, Baseline NI total score, age, and gender.

  • Difference in Mean Change From Baseline to Month 1 in Nocturia Impact (NI) Total Scores and Overall Impact Question for Responders and Non-Responders [ Time Frame: Day 1 (Baseline), Month 1 ]

    This outcome is a measure of sensitivity of the NI Diary to change in nocturia.

    The NI Diary is a 12-item instrument consisting of 11 core items and an overall impact question (Q12). The NI total score is defined as the sum of the 11 core items scores.

    The overall impact question (Q12) and the NI total score were transformed using Fisher's z transformation, i.e. the scores were based on a standardized scale from 0 (lowest impact) to 100 (highest impact).

    The difference in mean change in NI total score for subjects who experienced a reduction from baseline of <33% in nocturnal voids at the Month 1 visit (non-responders) versus those with a reduction in nocturnal voids from Baseline of ≥33% (responders) was estimated.

  • 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 [ Time Frame: Day 1 (Baseline), Month 1 ]

    The responsiveness of the NI Diary was measured with Cohen's D effect size. The effect size was calculated for active treatment versus placebo, based on change from Baseline to Month 1. The effect size was evaluated as "small," "medium," or "large" if D was <=0.35, >0.35 - 0.65, or >0.65, respectively.

    Mean values are the Cohen's D effect size. Standard deviation is the pooled standard deviation.

  • Correlation coefficients will be estimated between change from Baseline to Month 1 in nocturnal voids and NI total score [ Time Frame: 1 month ]
  • Difference in mean change in NI total score in 33% responders [ Time Frame: 1 month ]
  • Effect size/NI diary responsiveness [ Time Frame: 1 month ]
    Responsiveness of the NI diary, measured with Cohen´s D.
  • Internal Consistency and Intra-and-Inter-subject Reliability [ Time Frame: 1 month ]
    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 ]
    T-tests will be applied to explore the construct validity of the NI diary.
Complete list of historical versions of study NCT01552343 on ClinicalTrials.gov Archive Site
  • Internal Consistency of the Nocturia Impact (NI) Total Score for Each Day NI Diaries Were Completed Assessed as Cronbach's Alpha Values [ Time Frame: Screening (Day -20 to Day -18), Baseline (Day -2 to Day 1) and Treatment (Day 28 to Day 30) ]

    Cronbach's alpha (CA) is a measure of the internal consistency of the Nocturia Impact (NI) Total scores. Higher scores indicate a more reliable (precise) instrument. A value of 0.70 set as the benchmark for declaring the scale as internally consistent.

    Cronbach's alpha was assessed for each of the three consecutive days NI diaries were completed during screening (Day -20 to Day -18), baseline (Day -2 to Day 1) and Month 1 (Day 28 to Day 30).

  • Construct Validity For the Nocturia Impact (NI) Total Scores and Overall Impact Question (Q12) for Participants With High/Low Number of Nocturnal Voids [ Time Frame: Screening (Day -20), Baseline (Day 1) ]

    The known group validity was assessed by comparing participants who experienced ≥3 nocturnal voids to those who experienced <3 nocturnal voids, using the average over 3 days for the Screening and Baseline diaries. Results are reported for the NI Total Scores and the Overall Impact Question (Q12).

    The NI Diary is a 12-item instrument consisting of 11 core items and an overall impact question (Q12). The NI total score is defined as the sum of the 11 core items scores.

    The overall impact question (Q12) and the NI total score were transformed using Fisher's z transformation, i.e. the scores were based on a standardized scale from 0 (lowest impact) to 100 (highest impact).

  • Treatment Effect on Nocturia Impact (NI) Total Score: Change From Baseline to Month 1 [ Time Frame: Baseline (Day -2 to Day 1) to Month 1 ]
    Treatment effect on NI Total Score is modeled using an ANCOVA with covariates of baseline score, treatment and age stratum (<65, >=65). This study was not powered to show any treatment effect of NI total score using an ANCOVA.
  • Minimum Post-Treatment Serum Sodium Levels [ Time Frame: Day 1 up to 1 month ]
    Serum sodium levels were monitored since hyponatremia is a potential serious adverse event associated with daily doses of desmopressin. A participant was to be withdrawn from the trial if the serum sodium level was <=125 mmol/L at any time.
  • Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Day 1 up to 1 month ]
    A TEAE was any adverse event occurring after start of treatment and within the time of residual drug effect, i.e. within one day of the last dose of desmopressin.
Incidence of hyponatraemia as measured by serum sodium level [ Time Frame: 1 month ]
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Not Provided
 
Study Investigating the Impact Burden of Nocturia Using the Nocturia Impact Diary
A Double-blind, Randomized, Placebo-controlled Study Investigating the Impact Burden of Nocturia Using the Nocturia Impact Diary

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Treatment
Nocturia
  • 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®
  • 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: 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.
    Intervention: Drug: Desmopressin
  • 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.
    Intervention: Drug: Placebo
  • 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.
    Intervention: Drug: Desmopressin
  • 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.
    Intervention: Drug: Placebo
Holm-Larsen T, Andersson F, van der Meulen E, Yankov V, Rosen RC, Nørgaard 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
June 2012
May 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01552343
000034
No
Not Provided
Not Provided
Not Provided
Ferring Pharmaceuticals
Ferring Pharmaceuticals
Not Provided
Study Director: Clinical Development Support Ferring Pharmaceuticals
Ferring Pharmaceuticals
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP