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Therapeutic Areas: Nephrology/Urology
Disease Category: Nocturia

Trial Information

A Phase III Randomized, Double Blind, Placebo Control, Multicenter Study to Investigate the Efficacy and Safety of SER120 Nasal Spray Formulation in Patients with Nocturia

This is a randomized, double blind, placebo control, multi-center study to investigate the efficacy of SER120 nasal spray formulation to decrease the number of nocturic episodes in patients with nocturia. Patients will be screened to ensure that they met eligibility criteria within 21 days from treatment. Patients must have = 2 nocturic episodes per night for 5 or more nights per week for at least 6 months by history. A nocturic episode is defined as a non-incontinent urinary void of any volume at night during the patient’s normal hours of sleep following an initial period of sleep and, thereafter preceded and followed by sleep or an attempt to sleep. In addition, patients must have at least a 2-week voiding diary at screening to confirm eligibility (diary would include day time voiding frequency and night time voiding information). Screening procedures will consist of physical exam including nasopharyngeal exam and vitals, routine fasting labs (hematology, clinical chemistry and urinalysis) including serum sodium and serum osmolality concentrations, serology for HIV, Hepatitis B and C, ECG and 2 x 24-hour urine collection (separated by at least 1 week).

Eligible patient will be randomized to receive either the SER120 or placebo on Day 1. Fasting blood sample will be collected from each patient on Day 1 to establish serum sodium and serum osmolality at baseline. Patients will continue to maintain their daily voiding diary entries during the entire study.

Administration of the study drug is to be conducted in the evening prior to bedtime. Patients should make every effort to administer the study medication approximately ½ hour prior to bedtime.

Once randomized, patients will enter a 3-week dose titration phase for dose optimization. Patients may up-titrate on Day 8 or Day 15. Fasting morning serum sodium and serum osmolality will be assessed on Days 8 and 15. Dose decrease following up-titration on Day 8 may be made on Day 15 or sooner based on investigator’s judgment following discussion with the sponsor.

On Day 22, patients will return to the study center to start the 4-week Maintenance Phase of the study on the final titrated dose. Fasting morning serum sodium and serum osmolality will be assessed on Day 22.

On Day 29, patients will return to the study center for evaluation (serum sodium, serum osmolality vital signs, adverse events and diary assessments). Every attempt should be made to collect fasting morning blood samples from half of the enrolled patients and post breakfast (at least 2 hours post breakfast) blood samples from the other half of the enrolled patients.

On Day 43, patients will return to the study center for evaluation (serum sodium, serum osmolality vital signs and adverse events assessments). Every attempt should be made to collect fasting morning blood samples from half of the enrolled patients and post breakfast (at least 2 hours post breakfast) blood samples from the other half of the enrolled patients.

On Day 50, patients will return to the study for final assessments. A complete physical exam with nasopharyngeal exam, vital sign and ECG will be performed. Morning blood samples (fasting or at least 2 hours post breakfast) will be collected for assessment of desmopressin plasma level as well as for routine hematology and serum chemistry. A urine sample will be collected for urinalysis.

Selected patients will participate in the pharmacokinetic aspects of the study. Patients who have completed the maintenance period will be eligible to enter the 10-month open-label study.

At any time during the study, patients who show a hyponatremic event, which is defined as serum sodium < 130 mmol/L with clinical symptoms related to hyponatremia including headache, nausea, cardiac arrhythmias and neurological abnormalities or confirmed serum sodium = 125 mmol/L with or without clinical symptoms, will be withdrawn from the study.

Population Pharmacokinetics Twenty-four patients (12 male and 12 female) who are at the dose level 1 and 24 patients (12 males and 12 females) who are at dose level 2 will be administered 1 spray on the morning of Day 50.

Blood samples will be collected at 15, 30, 45, 60 and 90 minutes post. Patients will be monitored for about 3 hours in the study center post dose. Water intake should approximate urine output for 8 hours post dose.

Samples will be analyzed for desmopressin level using a validated RIA assay.

Number of Patients (planned and to be analyzed): Approximately 300 to 330 patients will be enrolled in the study to achieve at least 264 patients completing the study.

Inclusion Criteria:

• Male and female patients = 50 years of age.
• Documented nocturia (= 2 nocturic episodes/night, 5 or more days per week) for at least 6 months by history.
• Documented nocturia by diary (= 2 nocturic episodes/night, 5 or more days per week) for at least 2 weeks prior to treatment.

• Twenty-four hour urine output = 45 mL/kg or up to 3600 mL/24 hour
• Serum sodium concentration within normal limits.
• Serum triglycerides within normal limits
• Willing and able to sign informed consent and comply with all study requirements.

Exclusion Criteria

• Incontinence
• Diabetes insipidus (central or nephrogenic)
• Diabetes mellitus
• CHF (NYHA Class II to IV)
• Polydipsia or thirst disorders
• Uncontrolled hypertension
• Urinary retention (Post-void residual > 150 mL)
• Evidence of hepatic insufficiency
• Evidence of renal insufficiency (GFR < 55 mL/min)
• Baseline serum sodium level below the normal range
• History of SIADH
• Nephrotic syndrome
• Evidence of significant peripheral edema on physical exam (e.g., > 2+ pre-tibial edema)
• History of urinary bladder surgery or radiotherapy. Patient with BPH who have had surgery for urinary outlet obstruction more than 6 months prior to screening and are not incontinent are allowed into the study.
• Illness requiring systemic steroids during study.
• Female with unexplained pelvic masses or pelvic prolapse (greater than Stage II)
• Current or past urologic malignancy
• Clinical evidence of current UTI or microscopic hematuria that has not been fully evaluated, bladder stone, bladder pain syndrome or interstitial cystitis.
• Urinary bladder dysfunction of neurologic etiology that in the judgment of the investigator would interfere with the assessments of the study.
• Neurogenic detrusor dysfunction
• Obstructive sleep apnea
• Hyperkinetic limb disorders (e.g., restless leg syndrome) or other syndromes that disrupt sleep
• Work or life style activities that interfere with night time sleep
• Known alcohol or substance abuse within the last 12 months.
• Blood donation within the last 90 days.
• Smoking within the last 12 months.
• Positive for Hepatitis B surface antigen, Hepatitis C antibody or HIV
• Is pregnant or breast feeding
• Is on any investigational drug within 30 days or within 5 elimination half lives prior to screening whichever is longer.
• An acute illness or medical condition that results in fluid and/or electrolyte imbalance
• Any cardiopulmonary, renal or hepatic medical condition that in the judgment of the investigator would interfere with the assessments of the study.
• Other medical conditions which in the judgment of the investigator or medical monitor would make participation in the study unacceptable, e.g., allergic rhinitis or individuals using intranasal medication

AdvanceMed Research
2 Princess Rd., Suite J
Lawrenceville, NJ 8648
Phone: (609) 895-0735

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