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Treatment of Patients With Nocturia (Non-PK Study)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00937378
Recruitment Status : Completed
First Posted : July 13, 2009
Results First Posted : October 22, 2020
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Serenity Pharmaceuticals, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Nocturia
Interventions Drug: SER120
Drug: Placebo
Enrollment 326
Recruitment Details  
Pre-assignment Details  
Arm/Group Title SER120 Placebo
Hide Arm/Group Description All participants received SER120 500 ng once daily for at least 1 week and, if needed, participants were allowed to up-titrate to SER120 750 ng once daily for the remainder of the study. All participants received placebo once daily for at least 1 week and were allowed to undergo a mock up-titration once daily for the remainder of the study.
Period Title: Overall Study
Started 167 159
Completed 149 141
Not Completed 18 18
Arm/Group Title SER120 Placebo Total
Hide Arm/Group Description All participants received SER120 500 ng once daily for at least 1 week and, if needed, participants were allowed to up-titrate to SER120 750 ng once daily for the remainder of the study. All participants received placebo once daily for at least 1 week and were allowed to undergo a mock up-titration on placebo once daily for the remainder of the study. Total of all reporting groups
Overall Number of Baseline Participants 162 156 318
Hide Baseline Analysis Population Description
Intent-to-treat population
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 162 participants 156 participants 318 participants
64.4  (9.1) 64.6  (8.8) 64.5  (8.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 162 participants 156 participants 318 participants
Female
55
  34.0%
57
  36.5%
112
  35.2%
Male
107
  66.0%
99
  63.5%
206
  64.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 162 participants 156 participants 318 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   0.6%
0
   0.0%
1
   0.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
8
   4.9%
9
   5.8%
17
   5.3%
White
152
  93.8%
145
  92.9%
297
  93.4%
More than one race
1
   0.6%
2
   1.3%
3
   0.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 162 participants 156 participants 318 participants
162 156 318
1.Primary Outcome
Title Change in Mean Number of Nocturic Episodes/Night
Hide Description Change was calculated as the mean number of nocturic episodes per night between baseline and Week 7
Time Frame 7 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title SER120 Placebo
Hide Arm/Group Description:
All participants received SER120 500 ng once daily for at least 1 week and, if needed, participants were allowed to up-titrate to SER120 750 ng once daily for the remainder of the study.
All participants received placebo once daily for at least 1 week and were allowed to undergo a mock up-titration once daily for the remainder of the study.
Overall Number of Participants Analyzed 162 156
Least Squares Mean (Standard Deviation)
Unit of Measure: nocturic episodes per night
-1.3  (0.8) -1.2  (0.8)
2.Primary Outcome
Title Percent of Participants With at Least 50% Decrease in Mean Nocturic Episodes Per Night
Hide Description Percent of participants achieving at least 50% reduction in nocturic episodes during the last week of treatment compared to baseline
Time Frame 7 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title SER120 Placebo
Hide Arm/Group Description:
All participants received SER120 500 ng once daily for at least 1 week and, if needed, participants were allowed to up-titrate to SER120 750 ng once daily for the remainder of the study.
All participants received placebo once daily for at least 1 week and were allowed to undergo a mock up-titration once daily for the remainder of the study.
Overall Number of Participants Analyzed 162 156
Measure Type: Count of Participants
Unit of Measure: Participants
83
  51.2%
64
  41.0%
Time Frame [Not Specified]
Adverse Event Reporting Description Safety Population (only on participants who had received at least one dose of study drug and reported an adverse event).
 
Arm/Group Title SER120 Placebo
Hide Arm/Group Description All participants received SER120 500 ng once daily for at least 1 week and, if needed, participants were allowed to up-titrate to SER120 750 ng once daily for the remainder of the study. All participants received placebo once daily for at least 1 week and were allowed to undergo a mock up-titration on placebo once daily for the remainder of the study.
All-Cause Mortality
SER120 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
SER120 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/167 (1.80%)      1/159 (0.63%)    
Cardiac disorders     
Coronary artery disease *  1/167 (0.60%)  1 0/159 (0.00%)  0
Hepatobiliary disorders     
Cholelithiasis *  0/167 (0.00%)  0 1/159 (0.63%)  1
Infections and infestations     
Celulitis *  1/167 (0.60%)  1 0/159 (0.00%)  0
diverticulitis *  1/167 (0.60%)  1 0/159 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
ovarian cancer *  0/167 (0.00%)  0 1/159 (0.63%)  1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
SER120 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   112/167 (67.07%)      102/159 (64.15%)    
Eye disorders     
Lacrimation increased *  11/167 (6.59%)  11 10/159 (6.29%)  10
Nervous system disorders     
Headache *  13/167 (7.78%)  13 6/159 (3.77%)  6
Respiratory, thoracic and mediastinal disorders     
Nasal discomfort *  53/167 (31.74%)  53 48/159 (30.19%)  48
sneezing *  24/167 (14.37%)  24 27/159 (16.98%)  27
Rhinorrhea *  20/167 (11.98%)  20 16/159 (10.06%)  16
Nasal Congestion *  10/167 (5.99%)  10 8/159 (5.03%)  8
oropharyngeal pain *  4/167 (2.40%)  4 7/159 (4.40%)  7
*
Indicates events were collected by non-systematic assessment
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Serenity Pharmaceuticals
Phone: 8456396760 ext 17
EMail: sfein@serenitypharma.com
Layout table for additonal information
Responsible Party: Serenity Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00937378    
Other Study ID Numbers: SPC-SER120-DB2-200902
First Submitted: July 9, 2009
First Posted: July 13, 2009
Results First Submitted: August 27, 2020
Results First Posted: October 22, 2020
Last Update Posted: October 22, 2020