Trial Outcomes & Findings for Efficacy and Safety of Desmopressin (Nocturin®) 0.1 mg Tablets in Treatment of Nocturia in Participants With Benign Prostate Syndrome (BPS) (NCT NCT00902265)
NCT ID: NCT00902265
Last Updated: 2011-04-19
Results Overview
The number of nighttime voids was calculated over 48-hours period prior to baseline and week 12 visits. Calculated as Week 12 measure - Baseline measure.
COMPLETED
138 participants
Baseline, Week 12
2011-04-19
Participant Flow
This was a post marketing, non-randomized surveillance study. The 138 participants were screened from 60 German sites. The study planned for two visits - baseline (week 0 and week 12). Participants could opt for an optional visit between week 0 and week 12 (17 participants did not opt for optional visit).
Participant milestones
| Measure |
Desmopressin 0.1 mg
Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.
Drug given by prescription.
|
|---|---|
|
Overall Study
STARTED
|
138
|
|
Overall Study
Participants Who Received Treatment
|
137
|
|
Overall Study
COMPLETED
|
132
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Desmopressin 0.1 mg
Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.
Drug given by prescription.
|
|---|---|
|
Overall Study
Lost to Follow-up Prior to First Visit
|
1
|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Lack of Efficacy
|
2
|
|
Overall Study
Protocol Violation
|
1
|
Baseline Characteristics
Efficacy and Safety of Desmopressin (Nocturin®) 0.1 mg Tablets in Treatment of Nocturia in Participants With Benign Prostate Syndrome (BPS)
Baseline characteristics by cohort
| Measure |
Desmopressin 0.1 mg
n=137 Participants
Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.
Drug given by prescription.
|
|---|---|
|
Age Continuous
|
62.6 years
STANDARD_DEVIATION 7.8 • n=39 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
137 Participants
n=39 Participants
|
|
Region of Enrollment
Germany
|
137 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Intent to treat (ITT) population --All participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids)
The number of nighttime voids was calculated over 48-hours period prior to baseline and week 12 visits. Calculated as Week 12 measure - Baseline measure.
Outcome measures
| Measure |
Desmopressin 0.1 mg
n=132 Participants
Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.
Drug given by prescription.
|
|---|---|
|
Overall Mean Change From Baseline in Mean Number of Nighttime Voids at Week 12
|
-2.01 Number of nocturnal voids
Standard Deviation 1.13
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Intent to treat (ITT) population --All participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids)
The ratio of nighttime urine volume to 24-hour urine volume is calculated as the urine volume (volume of all voids after going to bed plus the first morning void) / 24-hour urine volume. Ratios are calculated at baseline and week 12 and difference between the two time points is reported here.
Outcome measures
| Measure |
Desmopressin 0.1 mg
n=114 Participants
Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.
Drug given by prescription.
|
|---|---|
|
Mean Change From Baseline in Ratio of Nighttime Urine Volume to 24-hour Urine Volume at Week 12
|
-14.0 ratio
Standard Deviation 11.9
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Intent to treat (ITT) population --All participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids)
Initial period of undisturbed sleep is calculated as the number of hours between falling asleep and waking for the first time during the night to void. Change is calculated at Week 12 - baseline.
Outcome measures
| Measure |
Desmopressin 0.1 mg
n=124 Participants
Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.
Drug given by prescription.
|
|---|---|
|
Mean Change From Baseline in Initial Period of Undisturbed Sleep at Week 12
|
1.69 Hours
Standard Deviation 1.16
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Intent to treat (ITT) population --All participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids)
The International Prostate Symptoms Score (IPSS) is a self-administered 8 item questionnaire designed to assess urination frequency and Quality of Life (QOL). The first 7 items are summed into a total score and question urination frequency. They are scaled 0-5, with higher numbers indicating greater severity of symptoms. The last question (item 8) concerns QOL and is scaled 0-6 where higher numbers indicate lower quality of life due to symptoms. The total scale across all questions is 0-41, with higher scores representing worse symptoms.
Outcome measures
| Measure |
Desmopressin 0.1 mg
n=131 Participants
Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.
Drug given by prescription.
|
|---|---|
|
Mean Change From Baseline of Total International Prostate Symptom Score (IPSS) at Week 12
|
-4.86 Units on a scale
Standard Deviation 4.22
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Intent to treat (ITT) population --All participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids).
The International Prostate Symptoms Score (IPSS) is a self-administered 8 item questionnaire designed to assess urination frequency and Quality of Life (QOL). The last question (item 8) concerns Quality of Life (QOL) and is scaled 0-6 where higher numbers indicate lower quality of life due to symptoms. Higher scores represent worse Quality of Life (QoL).
Outcome measures
| Measure |
Desmopressin 0.1 mg
n=117 Participants
Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.
Drug given by prescription.
|
|---|---|
|
Mean Change From Baseline International Prostate Symptom Score (IPSS) Quality of Life Score at Week 12
|
-1.56 Units on a scale
Standard Deviation 1.05
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Intent to treat (ITT) population --All participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids).
The LSEQ is a self-administered 10-item visual analog scale questionnaire designed to assess sleep quality. The 10 individual items are scored 1 to 100, with the total score ranging from 0 - 1,000. Higher numbers indicate lower sleep quality.
Outcome measures
| Measure |
Desmopressin 0.1 mg
n=129 Participants
Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.
Drug given by prescription.
|
|---|---|
|
Mean Change From Baseline in Total Score in Leeds Sleep Evaluation Questionnaire (LSEQ) at Week 12
|
-15.1 Units on a scale
Standard Deviation 12.1
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Intent to treat (ITT) population --All participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids).
The ICIQ-N is a self-administered 4-item questionnaire designed to assess the frequency and bother of daytime and nighttime urination. In questions 1 and 2 participants were asked to estimate the frequency of both daytime voiding (all voids before going to bed excluding the first morning void) and rate the degree of bother of daytime urination on a scale ranging from 0 (not at all) to 10 (a great deal). Higher numbers indicate lower Quality of Life (QoL).
Outcome measures
| Measure |
Desmopressin 0.1 mg
n=127 Participants
Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.
Drug given by prescription.
|
|---|---|
|
Change From Baseline in Degree of Bother Due to Frequency of Daytime Voiding Assessed by The International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N)
|
-2.25 Units on a scale
Standard Deviation 2.25
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Intent to treat (ITT) population --All participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids).
The ICIQ-N is a self-administered 4-item questionnaire designed to assess the frequency and bother of daytime and nighttime urination. In questions 3 and 4, participants were asked to estimate the frequency of nighttime voiding (number of voids after going to bed plus the first morning void) and rate the degree of bother of nighttime urination on a scale ranging from 0 (not at all) to 10 (a great deal). Higher numbers indicate lower Quality of Life (QOL).
Outcome measures
| Measure |
Desmopressin 0.1 mg
n=129 Participants
Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.
Drug given by prescription.
|
|---|---|
|
Change From Baseline in Degree of Bother Due to Frequency of Nighttime Voiding Assessed by The International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N)at Week 12
|
-4.00 Units on a scale
Standard Deviation 2.49
|
SECONDARY outcome
Timeframe: Week 1 to Week 12Population: Safety Population, consisting of participants who took at least one dose of desmopressin
Outcome measures
| Measure |
Desmopressin 0.1 mg
n=137 Participants
Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.
Drug given by prescription.
|
|---|---|
|
Participants With Treatment Emergent Adverse Events (AEs)
All Adverse Events
|
3 Participants
|
|
Participants With Treatment Emergent Adverse Events (AEs)
Deaths
|
0 Participants
|
|
Participants With Treatment Emergent Adverse Events (AEs)
Serious Adverse Events
|
0 Participants
|
|
Participants With Treatment Emergent Adverse Events (AEs)
AEs Leading to Discontinuation
|
2 Participants
|
Adverse Events
Desmopressin 0.1 mg
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI gives Ferring a draft manuscript 30 days before submission for the final form for to any journal for review and comments. Ferring can ask that confidential information be removed.
- Publication restrictions are in place
Restriction type: OTHER