Long Term Safety Assessment of SER120 in Patients With Nocturia

• Sponsor: Serenity Pharmaceuticals, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00981682
• Collaborator: (none)
• Enrollment: 376
• Location: 1
• Arm: 1
• Duration (Months): 24
• Patients Per Site Per Month: 15.7

Study Details

Study Description

Brief Summary

The hypothesis of this study is that SER120 is safe and well tolerated for use in nocturic patients.

Condition or Disease	Intervention/Treatment	Phase
Nocturia	Drug: SER120	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 376 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase III Open-Label Extension Study to Investigate the Safety of SER120 Nasal Spray Formulations in Patients With Nocturia Completing Study SPC-SER120-DB1-200901 or Study SPC-SER120-DB2-200902
• Study Start Date: Aug 1, 2009
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SER120 (desmopressin)	Drug: SER120; once a day treatment of nocturia

Outcome Measures

Primary Outcome Measures

1. Mean Serum Sodium [40 weeks]

   Change in mean serum sodium on Day 8, Day 15, Day 22, Week 4, Week 8, Week 12, Week 20, Week 28 and Week 40 compared to Baseline

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients completed SPC-SER120-DB1-200901 and SPC-SER120-DB2-200902 studies

• Willing to provide consent for the study

Exclusion Criteria:

• Incontinence

• Diabetes Insipidus, Diabetes Mellitus

• CHF

• Renal Insufficiency

• Significant medical history which make participation unacceptable

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stephen M. Auerbach, MD	Newport Beach	California	United States	92660

Sponsors and Collaborators

• Serenity Pharmaceuticals, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Serenity Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT00981682
• Other Study ID Numbers: SPC-SER120-OL1-200903
• First Posted: Sep 22, 2009
• Last Update Posted: Jan 20, 2021
• Last Verified: Jan 1, 2014

• Keywords provided by Serenity Pharmaceuticals, Inc.: decrease in the number of nocturic episodes for patients with nocturia
• Additional relevant MeSH terms: Nocturia

Study Results

Participant Flow

Arm/Group Title	SER120 750 mcg
Arm/Group Description	All participants received up to 750 mcg SER120 once daily
Period Title: Overall Study
STARTED	376
COMPLETED	234
NOT COMPLETED	142

Baseline Characteristics

Arm/Group Title	SER120 750 mcg
Arm/Group Description	All participants received up to 750 mcg SER120 once daily
Overall Participants	376
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.9 (9.0)
Sex: Female, Male (Count of Participants)
Female	126 33.5%
Male	250 66.5%
Region of Enrollment (Count of Participants)
United States	376 100%

Outcome Measures

1. Primary Outcome

Title	Mean Serum Sodium
Description	Change in mean serum sodium on Day 8, Day 15, Day 22, Week 4, Week 8, Week 12, Week 20, Week 28 and Week 40 compared to Baseline
Time Frame	40 weeks

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	SER120 750 mcg
Arm/Group Description	All participants received up to 750 mcg SER120 once daily
Measure Participants	376
Day 8	-0.0 (2.3)
Day 15	-0.4 (2.3)
Day 22	-0.4 (2.5)
Week 4	-0.3 (2.2)
Week 12	-0.5 (2.6)
Week 20	-0.4 (2.6)
Week 28	-0.8 (2.4)
Week 40	-0.6 (2.6)

Adverse Events

Time Frame	40 weeks
Arm/Group Title	SER120 750 mcg
Arm/Group Description	All participants received up to 750 mcg SER120 once daily
All Cause Mortality
	SER120 750 mcg
	Affected / at Risk (%)	# Events
Total	30/376 (8%)
Serious Adverse Events
	SER120 750 mcg
	Affected / at Risk (%)	# Events
Total	30/376 (8%)
Cardiac disorders
Atrial Fibrillation	1/376 (0.3%)	1
Cardiovascular disorders	1/376 (0.3%)	1
Coronary artery disease	1/376 (0.3%)	1
myocardial infarction	1/376 (0.3%)	1
pericarditis	1/376 (0.3%)	1
sick sinus syndrome	1/376 (0.3%)	1
Infections and infestations
Cellulitis	1/376 (0.3%)	1
Clostridium difficile colitis	1/376 (0.3%)	1
Gastroenteritis	1/376 (0.3%)	1
upper respiratory tract infection	1/376 (0.3%)	1
urinary tract infection	1/376 (0.3%)	1
Injury, poisoning and procedural complications
multiple injuries	1/376 (0.3%)	1
overdose	1/376 (0.3%)	1
post procedural hemorrhage	1/376 (0.3%)	1
Musculoskeletal and connective tissue disorders
Cervical vertebral fracture	1/376 (0.3%)	1
osteoarthritis	3/376 (0.8%)	3
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
basal cell carcinoma	2/376 (0.5%)	2
breast cancer	1/376 (0.3%)	1
malignant melanoma in situ	1/376 (0.3%)	1
Multiple myeloma	1/376 (0.3%)	1
Nervous system disorders
syncope	1/376 (0.3%)	1
Transient ischemic attack	1/376 (0.3%)	1
Psychiatric disorders
alcoholism	1/376 (0.3%)	1
Respiratory, thoracic and mediastinal disorders
asthma	1/376 (0.3%)	1
COPD	1/376 (0.3%)	1
interstitial lung disease	1/376 (0.3%)	1
Surgical and medical procedures
gastric banding	1/376 (0.3%)	1
medical device removal	1/376 (0.3%)	1
Uvulopalatopharyngoplasty	1/376 (0.3%)	1
Vascular disorders
hypertension	1/376 (0.3%)	1
Other (Not Including Serious) Adverse Events
	SER120 750 mcg
	Affected / at Risk (%)	# Events
Total	305/376 (81.1%)
Infections and infestations
Upper respiratory infection	23/376 (6.1%)	23
Nasopharyngitis	20/376 (5.3%)	20
sinusitis	17/376 (4.5%)	17
Nervous system disorders
headache	33/376 (8.8%)	33
Respiratory, thoracic and mediastinal disorders
Nasal discomfort	86/376 (22.9%)	86
sneezing	46/376 (12.2%)	46
Rhinorrhea	43/376 (11.4%)	43
epistaxis	19/376 (5.1%)	19
cough	18/376 (4.8%)	18

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.