Study to Investigate the Safety and Pharmacokinetics of SER120 Nasal Spray in Elderly Patients With Nocturia

• Sponsor: Serenity Pharmaceuticals, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01259128
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Arms: 2
• Duration (Months): 7
• Patients Per Site Per Month: 4.6

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if SER120 nasal spray is well tolerated in 75 years or older nocturic patients.

Condition or Disease	Intervention/Treatment	Phase
Nocturia	Drug: SER120 Nasal Spray 500 ng/day; Drug: SER120 nasal spray 750 ng/day	Phase 3

Detailed Description

Patients entering the study are randomized to either Level 1 SER120 nasal spray concentration or Level 2 SER120 nasal spray concentration

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase III Randomized, Open-Label, Multicenter Study to Investigate the Safety and Pharmacokinetics of SER120 Nasal Spray Formulations in Elderly Patients (≥ 75 Years Old) With Nocturia
• Study Start Date: Apr 1, 2010
• Actual Primary Completion Date: Nov 1, 2010
• Actual Study Completion Date: Nov 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SER120 500 ng/day SER120 Level 1 (500 ng/day)	Drug: SER120 Nasal Spray 500 ng/day; SER120 Level 1
Experimental: SER120 750 ng/day SER120 Level 2 (750 ng/day)	Drug: SER120 nasal spray 750 ng/day; SER120 (750 ng/day)

Outcome Measures

Primary Outcome Measures

1. Serum Sodium Levels at Baseline and During Treatment [baseline, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43 and Day 57]

   Mean serum sodium reported at baseline, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43 and Day 57.

Secondary Outcome Measures

1. Change in Mean Nocturic Episodes Per Night [Mean value at Week 8 minus mean value at baseline]

   Change in mean nocturic episodes per night between baseline and Week 8

2. Percent of Participants With Greater or Equal to 50% Reduction in the Number of Nocturic Episodes [8 weeks]

   Percent of participants with greater or equal to 50% reduction in number of nocturic episodes at Week 8 compared to Baseline

Eligibility Criteria

Criteria

• Ages Eligible for Study: 75 Years to 95 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male & female greater or equal to 75 years of age, history of nocturia

Exclusion Criteria:

• CHF, Diabetes, Diabetes Insipidus, Renal Insufficiency, Heptatic Insufficiency, Incontinence, Illness requiring steroid, current or past urologic maliganancy, nephrotic syndrome

• Unexplained pelvic masses

• Urinary bladder surgery or radiotherapy

• Sleep apnea

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dr. Jolene Berg	San Antonio	Texas	United States	78229

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: NCT01259128
• Other Study ID Numbers: SPC-SER120-ELD-2010-01
• First Posted: Dec 13, 2010
• Last Update Posted: Nov 17, 2020
• Last Verified: Apr 1, 2014

• Additional relevant MeSH terms: Nocturia

Study Results

Participant Flow

Arm/Group Title	SER120 500 ng	SER120 750 ng
Arm/Group Description	All participants received 500 ng once daily	All participants received 750 ng once daily
Period Title: Overall Study
STARTED	15	17
COMPLETED	15	15
NOT COMPLETED	0	2

Baseline Characteristics

Arm/Group Title	SER120 500 ng	SER120 750 ng	Total
Arm/Group Description	All participants received 500 ng once daily	All participants received 750 ng once daily	Total of all reporting groups
Overall Participants	15	16	31
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	79 (3.6)	79.1 (3.3)	79.1 (3.4)
Sex: Female, Male (Count of Participants)
Female	5 33.3%	5 31.3%	10 32.3%
Male	10 66.7%	11 68.8%	21 67.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 6.7%	0 0%	1 3.2%
White	14 93.3%	16 100%	30 96.8%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	15 100%	16 100%	31 100%

Outcome Measures

1. Primary Outcome

Title	Serum Sodium Levels at Baseline and During Treatment
Description	Mean serum sodium reported at baseline, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43 and Day 57.
Time Frame	baseline, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43 and Day 57

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	SER120 500 ng	SER120 750 ng
Arm/Group Description	All participants received 500 ng once daily	All participants received 750 ng once daily
Measure Participants	15	17
Baseline	141.0 (2.4)	140.0 (1.7)
Day 4	139.2 (3.0)	140.3 (1.3)
Day 8	139.1 (3.2)	140.4 (1.8)
Day 15	140.4 (2.1)	140.2 (1.4)
Day 22	139.5 (3.2)	140.0 (1.4)
Day 29	139.7 (2.7)	139.7 (2.1)
Day 43	139.9 (2.7)	139.6 (1.5)
Day 57	140.9 (2.6)	141.1 (1.7)

2. Secondary Outcome

Title	Change in Mean Nocturic Episodes Per Night
Description	Change in mean nocturic episodes per night between baseline and Week 8
Time Frame	Mean value at Week 8 minus mean value at baseline

Outcome Measure Data

Analysis Population Description

Intent-to-Treat Population

Arm/Group Title	SER120 500 ng	SER120 750 ng
Arm/Group Description	All participants received 500 ng once daily	All participants received 750 ng once daily
Measure Participants	15	16
Mean (Standard Deviation) [nocturic episodes per night]	-1.5 (0.8)	-1.4 (0.7)

3. Secondary Outcome

Title	Percent of Participants With Greater or Equal to 50% Reduction in the Number of Nocturic Episodes
Description	Percent of participants with greater or equal to 50% reduction in number of nocturic episodes at Week 8 compared to Baseline
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

Intent-To-Treat Polpulation

Arm/Group Title	SER120 500 ng	SER120 750 ng
Arm/Group Description	All participants received 500 ng once daily	All participants received 750 ng once daily
Measure Participants	15	16
Count of Participants [Participants]	11 73.3%	11 68.8%

Adverse Events

Time Frame	8 Weeks
Adverse Event Reporting Description	Safety Population
Arm/Group Title	SER120 500 ng		SER120 750 ng
Arm/Group Description	All participants received 500 ng once daily		All participants received 750 ng once daily
All Cause Mortality
	SER120 500 ng		SER120 750 ng
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	SER120 500 ng		SER120 750 ng
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/17 (0%)
Other (Not Including Serious) Adverse Events
	SER120 500 ng		SER120 750 ng
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/15 (53.3%)		12/17 (70.6%)
Cardiac disorders
Atrial Fibrillation	0/15 (0%)	0	1/17 (5.9%)	1
Eye disorders
lacrimation increased	1/15 (6.7%)	1	2/17 (11.8%)	2
abnormal sensation in eye	1/15 (6.7%)	1	0/17 (0%)	0
Gastrointestinal disorders
diarrhea	2/15 (13.3%)	2	0/17 (0%)	0
abdominal pain upper	0/15 (0%)	0	1/17 (5.9%)	1
chapped lips	0/15 (0%)	0	1/17 (5.9%)	1
Constipation	0/15 (0%)	0	1/17 (5.9%)	1
dry mouth	1/15 (6.7%)	1	0/17 (0%)	0
gastroesophageal reflux disease	0/15 (0%)	0	1/17 (5.9%)	1
gingival pain	1/15 (6.7%)	1	0/17 (0%)	0
hypoaesthesia oral	1/15 (6.7%)	1	0/17 (0%)	0
oral pain	0/15 (0%)	0	1/17 (5.9%)	1
vomiting	0/15 (0%)	0	1/17 (5.9%)	1
General disorders
Chills	0/15 (0%)	0	1/17 (5.9%)	1
Pyrexia	0/15 (0%)	0	1/17 (5.9%)	1
sensation of pressure	1/15 (6.7%)	1	0/17 (0%)	0
Infections and infestations
nasopharyngitis	1/15 (6.7%)	1	1/17 (5.9%)	1
Injury, poisoning and procedural complications
Excoriation	0/15 (0%)	0	1/17 (5.9%)	1
Incisional hernia	0/15 (0%)	0	1/17 (5.9%)	1
Joint sprain	1/15 (6.7%)	1	0/17 (0%)	0
procedural pain	0/15 (0%)	0	1/17 (5.9%)	1
Musculoskeletal and connective tissue disorders
muscle spasms	1/15 (6.7%)	1	0/17 (0%)	0
pain in extremity	0/15 (0%)	0	1/17 (5.9%)	1
Nervous system disorders
headache	1/15 (6.7%)	1	1/17 (5.9%)	1
dizziness	1/15 (6.7%)	1	0/17 (0%)	0
Renal and urinary disorders
urinary hesitation	0/15 (0%)	0	1/17 (5.9%)	1
Respiratory, thoracic and mediastinal disorders
nasal discomfort	6/15 (40%)	6	6/17 (35.3%)	6
sneezing	1/15 (6.7%)	1	4/17 (23.5%)	4
rhinorrhea	1/15 (6.7%)	1	2/17 (11.8%)	2
rhinalgia	1/15 (6.7%)	1	1/17 (5.9%)	1
cough	1/15 (6.7%)	1	0/17 (0%)	0
dyspnea	0/15 (0%)	0	1/17 (5.9%)	1
epistaxis	0/15 (0%)	0	1/17 (5.9%)	1
oropharyngeal pain	0/15 (0%)	0	1/17 (5.9%)	1
paranasal sinus discomfort	1/15 (6.7%)	1	0/17 (0%)	0
sinus disorder	0/15 (0%)	0	1/17 (5.9%)	1
throat irritation	1/15 (6.7%)	1	0/17 (0%)	0
Skin and subcutaneous tissue disorders
dermatitis contact	0/15 (0%)	0	1/17 (5.9%)	1
Surgical and medical procedures
sebaceous cyst excision	0/15 (0%)	0	1/17 (5.9%)	1
skin cosmetic procedure	0/15 (0%)	0	1/17 (5.9%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There IS 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.