Status:
COMPLETED
Comparative Trial to Investigate the Dose-Response of 4 Different Dose Levels of Minirin Melt and Placebo
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Nocturia
Eligibility:
All Genders
55-75 years
Phase:
PHASE2
Brief Summary
This is a multi-centre, randomised, placebo-controlled, double-blind, parallel-group comparative trial to be conducted in nocturia patients. The trial is designed to characterize the dose-response rel...
Eligibility Criteria
Inclusion
- Given written informed consent prior to any trial-related activity is performed
- Aged 55-75 years
- Mean number of nocturnal voids of at least two per night
- Reached post-menopause (applicable to females only)
Exclusion
- Evidence of bladder outlet obstruction (BOO); or a urine flow of less than 5 mL/s (applicable to males only)
- A surgical treatment for BOO or prostatic hyperplasia within the past 6 months (applicable to males only)
- Showing symptoms of any of the following diseases and having a mean number of nocturnal voids exceeding four per night: Benign prostatic hyperplasia, overactive bladder, interstitial cystitis, severe stress urinary incontinence
- Psychosomatic or habitual polydipsia
- Urinary retention; or a post void residual volume in excess of 150 mL
- A history or complication of urologic malignancy (e.g. bladder cancer or prostate cancer)
- Complication of genito-urinary pathology (e.g. infection, stone, or neoplasia)
- Complication of neurogenic detrusor activity
- Complication or suspicion of heart failure
- Uncontrolled hypertension
- Uncontrolled diabetes mellitus
- Complication of hepatobiliary disease
- Abnormal serum creatinine level
- Complication of hyponatraemia, or serum sodium level \<135 mEq/L
- Central or nephrogenic diabetes insipidus (CDI or NDI)
- Syndrome of inappropriate antidiuretic hormone (SIADH)
- Obstructive sleep apnea
- Alcohol dependency or drug abuse
- A job or lifestyle that may interfere with regular night-time sleep
- Previous desmopressin treatment
- Treatment with another investigational product within the past 3 months
- A need for treatment with a prohibited concomitant drug for a complication or other problem
- A mental condition, the lack of decision-making ability, dementia or a speech handicap
- Any other reason that the Investigator believes inappropriate
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT01184859
Start Date
July 1 2010
End Date
April 1 2011
Last Update
May 25 2012
Active Locations (36)
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1
Japanese Red Cross Nagoya Daiichi Hospital
Nagoya, Aichi-ken, Japan
2
National Center for Geriatrics and Gerontology
Ōbu, Aichi-ken, Japan
3
Kokuho Asahi Central Hospital
Asahi, Chiba, Japan
4
University of Fukui Hospital
Yoshida, Fukui, Japan