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A Trial to Investigate Efficacy, Safety and Tolerability of FE 201836 for Nocturia Due to Nocturnal Polyuria in Adults

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ClinicalTrials.gov Identifier: NCT03201419
Recruitment Status : Completed
First Posted : June 28, 2017
Results First Posted : December 23, 2020
Last Update Posted : December 23, 2020
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Brief Summary:
The purpose of this trial was to investigate the efficacy, safety and tolerability of different oral doses of FE 201836, with desmopressin as a benchmark, during 12 weeks of treatment for nocturia due to nocturnal polyuria in adults

Condition or disease Intervention/treatment Phase
Nocturia Drug: FE 201836 Drug: Desmopressin Drug: Placebo oral solution Drug: Placebo ODT Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 302 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The trial consisted of a 2 week period of screening/lifestyle changes during which no treatment was given, a 2 week enrichment period (including a 1 week single blind active run-in period [FE 201836 500 µg] and a 1 week washout period) followed by a 12 week randomized treatment period for each subject. Prior to the first interim analysis, the first 129 subjects were randomized to daily treatment with FE 201836 500 µg, placebo, or desmopressin (25 µg for females and 50 µg for males) in a 2:2:1 ratio. After the first interim analysis, subjects were randomized to daily treatment with FE 201836 (50 µg, 100 µg, 150 µg, 250 µg, 350 µg, or 500 µg), placebo, or desmopressin (25 µg for females and 50 µg for males) using response adaptive allocation probabilities.
Masking: Double (Participant, Investigator)
Masking Description: Each subject will receive 2 medications (an oral solution and an orally disintegrating tablet (ODT) formulation) throughout the trial, in order to keep the treatment blinded.
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled, Response-adaptive Dose-finding Trial Investigating the Efficacy, Safety and Tolerability of Oral Doses of FE 201836, With Desmopressin Orally Disintegrating Tablet as a Benchmark, During 12 Weeks of Treatment for Nocturia Due to Nocturnal Polyuria in Adults
Actual Study Start Date : July 27, 2017
Actual Primary Completion Date : October 31, 2019
Actual Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FE 201836 500 μg (Randomized Treatment Period)
FE 201836 500 μg oral solution and placebo orally disintegrating tablet (ODT), administered once daily
Drug: FE 201836
Oral solution for daily intake

Drug: Placebo ODT
Manufactured to mimic experimental drug

Experimental: FE 201836 350 μg (Randomized Treatment Period)
FE 201836 350 μg oral solution and placebo ODT, administered once daily
Drug: FE 201836
Oral solution for daily intake

Drug: Placebo ODT
Manufactured to mimic experimental drug

Experimental: FE 201836 250 μg (Randomized Treatment Period)
FE 201836 250 μg oral solution and placebo ODT, administered once daily
Drug: FE 201836
Oral solution for daily intake

Drug: Placebo ODT
Manufactured to mimic experimental drug

Experimental: FE 201836 150 μg (Randomized Treatment Period)
FE 201836 150 μg oral solution and placebo ODT, administered once daily
Drug: FE 201836
Oral solution for daily intake

Drug: Placebo ODT
Manufactured to mimic experimental drug

Experimental: FE 201836 100 μg (Randomized Treatment Period)
FE 201836 100 μg oral solution and placebo ODT, administered once daily
Drug: FE 201836
Oral solution for daily intake

Drug: Placebo ODT
Manufactured to mimic experimental drug

Experimental: FE 201836 50 μg (Randomized Treatment Period)
FE 201836 50 μg oral solution and placebo ODT, administered once daily
Drug: FE 201836
Oral solution for daily intake

Drug: Placebo ODT
Manufactured to mimic experimental drug

Experimental: Placebo (Randomized Treatment Period)
Placebo oral solution and placebo ODT, administered once daily
Drug: Placebo oral solution
Manufactured to mimic experimental drug

Drug: Placebo ODT
Manufactured to mimic experimental drug

Experimental: Desmopressin 25 μg (Randomized Treatment Period)
Desmopressin 25 μg ODT and placebo oral solution, administered once daily (female subjects)
Drug: Desmopressin
Desmopressin Orally Disintegrating Tablet (ODT)
Other Name: NOCDURNA

Drug: Placebo oral solution
Manufactured to mimic experimental drug

Experimental: Desmopressin 50 μg (Randomized Treatment Period)
Desmopressin 50 μg ODT and placebo oral solution, administered once daily (male subjects)
Drug: Desmopressin
Desmopressin Orally Disintegrating Tablet (ODT)
Other Name: NOCDURNA

Drug: Placebo oral solution
Manufactured to mimic experimental drug




Primary Outcome Measures :
  1. Change From Baseline in Aggregated Mean Number of Nocturnal Voids During 12 Weeks of Treatment [ Time Frame: Baseline, during 12 weeks of treatment ]

    Nocturnal voids were defined as voids occuring from 5 minutes after bedtime until rising in the morning.

    The number of nocturnal voids at each visit was calculated as the average over the 3 consecutive 24 hour periods just prior to the respective visit. The visit-specific means were aggregated into a mean of current and preceding visits.

    Level estimated for baseline value of mean number of nocturnal voids equal to 2, and 95% credibility interval (2.5 and 97.5 percentiles of the posterior distribution) instead of confidence interval are presented in this endpoint.



Secondary Outcome Measures :
  1. Change From Baseline in Mean Number of Nocturnal Voids at Week 1 [ Time Frame: Baseline, Week 1 ]

    Nocturnal voids were defined as voids occuring from 5 minutes after bedtime until rising in the morning.

    The number of nocturnal voids at each visit was calculated as the average over the 3 consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in nocturnal voids are estimated using a baseline value of 2.

    MMRM=Mixed Model for Repeated Measurements.

    For all visit-specific results, the tables present the number of subjects with an observation of the endpoints in question at the specific visit. All secondary analyses are performed using the observed-case approach based on repeated measurements for all subjects in the ITT-RT population. That is, these secondary analyses are based on all subjects with at least one non-missing post-baseline observation (with a baseline value if relevant).


  2. Change From Baseline in Mean Number of Nocturnal Voids at Week 4 [ Time Frame: Baseline, Week 4 ]

    Nocturnal voids were defined as voids occuring from 5 minutes after bedtime until rising in the morning.

    The number of nocturnal voids at each visit was calculated as the average over the 3 consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in nocturnal voids are estimated using a baseline value of 2.


  3. Change From Baseline in Mean Number of Nocturnal Voids at Week 8 [ Time Frame: Baseline, Week 8 ]

    Nocturnal voids were defined as voids occuring from 5 minutes after bedtime until rising in the morning.

    The number of nocturnal voids at each visit was calculated as the average over the 3 consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in nocturnal voids are estimated using a baseline value of 2.


  4. Change From Baseline in Mean Number of Nocturnal Voids at Week 12 [ Time Frame: Baseline, Week 12 ]

    Nocturnal voids were defined as voids occuring from 5 minutes after bedtime until rising in the morning.

    The number of nocturnal voids at each visit was calculated as the average over the 3 consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in nocturnal voids are estimated using a baseline value of 2.


  5. Responder Rate in Nocturnal Voids at Week 1 [ Time Frame: Week 1 ]

    Defined as 50% reduction in nocturnal voids from baseline.

    Adjusted visit-specific estimated odds of at least 50% in the reduction mean number of nocturnal voids are estimated using a baseline value of 2.

    The estimated odd equals the probability of response divided by the probability of non-response; these odds may vary between 0 and infinity. For example, if the probability of responding is 80%, the odd of responding is 4, as it is 4 times more likely to respond (80%) then it is not to respond (20%).


  6. Responder Rate in Nocturnal Voids at Week 4 [ Time Frame: Week 4 ]

    Defined as 50% reduction in nocturnal voids from baseline.

    Adjusted visit-specific estimated odds of at least 50% reduction in the mean number of nocturnal voids are estimated using a baseline value of 2.

    The estimated odd equals the probability of response divided by the probability of non-response; these odds may vary between 0 and infinity. For example, if the probability of responding is 80%, the odd of responding is 4, as it is 4 times more likely to respond (80%) then it is not to respond (20%).


  7. Responder Rate in Nocturnal Voids at Week 8 [ Time Frame: Week 8 ]

    Defined as 50% reduction in nocturnal voids from baseline.

    Adjusted visit-specific estimated odds of at least 50% reduction in the mean number of nocturnal voids are estimated using a baseline value of 2.

    The estimated odd equals the probability of response divided by the probability of non-response; these odds may vary between 0 and infinity. For example, if the probability of responding is 80%, the odd of responding is 4, as it is 4 times more likely to respond (80%) then it is not to respond (20%).


  8. Responder Rate in Nocturnal Voids at Week 12 [ Time Frame: Week 12 ]

    Defined as 50% reduction in nocturnal voids from baseline.

    Adjusted visit-specific estimated odds of at least 50% reduction in the mean number of nocturnal voids are estimated using a baseline value of 2.

    The estimated odd equals the probability of response divided by the probability of non-response; these odds may vary between 0 and infinity. For example, if the probability of responding is 80%, the odd of responding is 4, as it is 4 times more likely to respond (80%) then it is not to respond (20%).


  9. Responder Rate in Nocturnal Voids During 12 Weeks of Treatment [ Time Frame: During 12 weeks of treatment ]

    Defined as 50% reduction in nocturnal voids from baseline.

    Estimated odds of at least 50% reduction in the aggregated mean number of nocturnal voids for a subject with 2 nocturnal voids at baseline are presented in this endpoint.

    The 95% credibility interval (2.5 and 97.5 percentiles of the posterior distribution) instead of confidence interval is presented for this endpoint.

    The estimated odd equals the probability of response divided by the probability of non-response; these odds may vary between 0 and infinity. For example, if the probability of responding is 80%, the odd of responding is 4, as it is 4 times more likely to respond (80%) then it is not to respond (20%).


  10. Change From Baseline in Mean NI Diary Total Score at Week 1 [ Time Frame: Baseline, Week 1 ]

    The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall quality of life (QoL) impact question (Q12). The NI Diary Total Scores are calculated by summing the 11 core items.Responses are scored from 0 to 4 (lowest t o highest impact). The NI Diary Total is standardized from 0 to 100 (lowest to highest impact).

    The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Total Score are estimated using a baseline value of 40.


  11. Change From Baseline in Mean NI Diary Total Score at Week 4 [ Time Frame: Baseline, Week 4 ]

    The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). The NI Diary Total Scores are calculated by summing the 11 core items. Responses are scored from 0 to 4 (lowest to highest impact). The NI Diary Total is standardized from 0 to 100 (lowest to highest impact).

    The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Total Score are estimated using a baseline value of 40.


  12. Change From Baseline in Mean NI Diary Total Score at Week 8 [ Time Frame: Baseline, Week 8 ]

    The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). The NI Diary Total Scores are calculated by summing the 11 core items. Responses are scored from 0 to 4 (lowest to highest impact). The NI Diary Total is standardized from 0 to 100 (lowest to highest impact).

    The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Total Score are estimated using a baseline value of 40.


  13. Change From Baseline in Mean NI Diary Total Score at Week 12 [ Time Frame: Baseline, Week 12 ]

    The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). The NI Diary Total Scores are calculated by summing the 11 core items. Responses are scored from 0 to 4 (lowest to highest impact). The NI Diary Total is standardized from 0 to 100 (lowest to highest impact).

    The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Total Score are estimated using a baseline value of 40.


  14. Change From Baseline in Aggregated Mean NI Diary Total Score During 12 Weeks of Treatment [ Time Frame: Baseline, during 12 weeks of treatment ]

    The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). The NI Diary Total Scores are calculated by summing the 11 core items. Responses are scored from 0 to 4 (lowest to highest impact). The NI Diary Total is standardized from 0 to 100 (lowest to highest impact).

    The score at each visit was calculated as the mean over the three consecutive 24 hour periods just prior to the respective visit. The visit-specific means were aggregated into a mean of current and preceding visits.

    Level estimated for baseline value of mean NI Diary Total Score equal to 40 is presented in this endpoint.

    The 95% credibility interval (2.5 and 97.5 percentiles of the posterior distribution) instead of confidence interval is presented for this endpoint.


  15. Percentage of Nights With at Most One Nocturnal Void During 12 Weeks of Treatment [ Time Frame: During 12 weeks of treatment ]

    The percentages of nights during the treatment period with at most one nocturnal void are presented in this endpoint.

    Level estimated for baseline value of mean number of nocturnal voids equal to 2 is presented in this endpoint.


  16. Percentage of Nights With No Nocturnal Voids During 12 Weeks of Treatment [ Time Frame: During 12 weeks of treatment ]

    The percentages of nights during the treatment period with complete response, i.e. no nocturnal voids are presented in this endpoint.

    Level estimated for baseline value of mean number of nocturnal voids equal to 2 is presented in this endpoint.


  17. Change From Baseline in Mean NI Diary Overall Impact Score at Week 1 [ Time Frame: Baseline, Week 1 ]

    The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). For the overall impact question (Q12), response options range from 0 (not at all) to 4 (a great deal). The NI Diary Overall Impact Scores are standardized from 0 to 100 (lowest to highest impact).

    The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Overall Impact Score are estimated using a baseline value of 40.


  18. Change From Baseline in Mean NI Diary Overall Impact Score at Week 4 [ Time Frame: Baseline, Week 4 ]

    The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). For the overall impact question (Q12), response options range from 0 (not at all) to 4 (a great deal). The NI Diary Overall Impact Scores are standardized from 0 to 100 (lowest to highest impact).

    The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Overall Impact Score are estimated using a baseline value of 40.


  19. Change From Baseline in Mean NI Diary Overall Impact Score at Week 8 [ Time Frame: Baseline, Week 8 ]

    The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). For the overall impact question (Q12), response options range from 0 (not at all) to 4 (a great deal). The NI Diary Overall Impact Scores are standardized from 0 to 100 (lowest to highest impact).

    The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Overall Impact Score are estimated using a baseline value of 40.


  20. Change From Baseline in Mean NI Diary Overall Impact Score at Week 12 [ Time Frame: Baseline, Week 12 ]

    The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). For the overall impact question (Q12), response options range from 0 (not at all) to 4 (a great deal). The NI Diary Overall Impact Scores are standardized from 0 to 100 (lowest to highest impact).

    The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Overall Impact Score are estimated using a baseline value of 40.


  21. Change From Baseline in Aggregated Mean NI Diary Overall Impact Score During 12 Weeks of Treatment [ Time Frame: Baseline, during 12 weeks of treatment ]

    The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). For the overall impact question (Q12), response options range from 0 (not at all) to 4 (a great deal). The NI Diary Overall Impact Scores are standardized from 0 to 100 (lowest to highest impact).

    The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. The visit-specific means were aggregated into a mean of current and preceding visits.

    Level estimated for baseline value of mean NI Diary Overall Impact Score equal to 40 is presented in this endpoint.

    The 95% credibility interval (2.5 and 97.5 percentiles of the posterior distribution) instead of confidence interval is presented for this endpoint.


  22. Patient Global Impression of Improvement (PGI-I) Urinary Symptoms Scores at Week 1 [ Time Frame: Week 1 ]

    The PGI-I is a 1-item questionnaire designed to assess the patient's impression of changes in urinary symptoms. The PGI-I was scored from 1 (very much better) to 7 (very much worse).

    Visit-specific PGI-I in urinary symptoms is presented in this endpoint.


  23. Patient Global Impression of Improvement (PGI-I) Urinary Symptoms Scores at Week 4 [ Time Frame: Week 4 ]

    The PGI-I is a 1-item questionnaire designed to assess the patient's impression of changes in urinary symptoms. The PGI-I was scored from 1 (very much better) to 7 (very much worse).

    Visit-specific PGI-I in urinary symptoms is presented in this endpoint.


  24. Patient Global Impression of Improvement (PGI-I) Urinary Symptoms Scores at Week 8 [ Time Frame: Week 8 ]

    The PGI-I is a 1-item questionnaire designed to assess the patient's impression of changes in urinary symptoms. The PGI-I was scored from 1 (very much better) to 7 (very much worse).

    Visit-specific PGI-I in urinary symptoms is presented in this endpoint.


  25. Patient Global Impression of Improvement (PGI-I) Urinary Symptoms Scores at Week 12 [ Time Frame: Week 12 ]

    The PGI-I is a 1-item questionnaire designed to assess the patient's impression of changes in urinary symptoms. The PGI-I was scored from 1 (very much better) to 7 (very much worse).

    Visit-specific PGI-I in urinary symptoms is presented in this endpoint.


  26. Change From Baseline in Patient Global Impression of Severity (PGI-S) Scores at Week 1 [ Time Frame: Baseline, Week 1 ]

    The PGI-S is a 1-item questionnaire designed to assess patient's impression of disease severity. The PGI-S was scored from 1 (none) to 4 (severe).

    Change from baseline in visit-specific PGI-S is presented in this endpoint.

    Level estimated for baseline value of PGI-S equal to 3 is presented in this endpoint.


  27. Change From Baseline in PGI-S Scores at Week 4 [ Time Frame: Baseline, Week 4 ]

    The PGI-S is a 1-item questionnaire designed to assess patient's impression of disease severity. The PGI-S was scored from 1 (none) to 4 (severe).

    Change from baseline in visit-specific PGI-S is presented in this endpoint.

    Level estimated for baseline value of PGI-S equal to 3 is presented in this endpoint.


  28. Change From Baseline in PGI-S Scores at Week 8 [ Time Frame: Baseline, Week 8 ]

    The PGI-S is a 1-item questionnaire designed to assess patient's impression of disease severity. The PGI-S was scored from 1 (none) to 4 (severe).

    Change from baseline in visit-specific PGI-S is presented in this endpoint.

    Level estimated for baseline value of PGI-S equal to 3 is presented in this endpoint.


  29. Change From Baseline in PGI-S Scores at Week 12 [ Time Frame: Baseline, Week 12 ]

    The PGI-S is a 1-item questionnaire designed to assess patient's impression of disease severity. The PGI-S was scored from 1 (none) to 4 (severe).

    Change from baseline in visit-specific PGI-S is presented in this endpoint.

    Level estimated for baseline value of PGI-S equal to 3 is presented in this endpoint.


  30. Change From Baseline in Hsu 5-point Likert Bother Scale at Week 1 [ Time Frame: Baseline, Week 1 ]

    The Hsu 5-point Likert Bother scale is a questionnaire designed to assess the subjective bothersomeness and functional disruptiveness of nocturia. The Hsu 5 point Likert Bother Scale was scored from 0 (not at all) to 4 (extremely).

    Change from baseline in visit-specific Hsu Bother is presented in this endpoint.

    Level estimated for baseline value of Hsu Bother equal to 3 is presented in this endpoint.


  31. Change From Baseline in Hsu 5-point Likert Bother Scale at Week 4 [ Time Frame: Baseline, Week 4 ]

    The Hsu 5-point Likert Bother scale is a questionnaire designed to assess the subjective bothersomeness and functional disruptiveness of nocturia. The Hsu 5 point Likert Bother Scale was scored from 0 (not at all) to 4 (extremely).

    Change from baseline in visit-specific Hsu Bother is presented in this endpoint.

    Level estimated for baseline value of Hsu Bother equal to 3 is presented in this endpoint.


  32. Change From Baseline in Hsu 5-point Likert Bother Scale at Week 8 [ Time Frame: Baseline, Week 8 ]

    The Hsu 5-point Likert Bother scale is a questionnaire designed to assess the subjective bothersomeness and functional disruptiveness of nocturia. The Hsu 5 point Likert Bother Scale was scored from 0 (not at all) to 4 (extremely).

    Change from baseline in visit-specific Hsu Bother is presented in this endpoint.

    Level estimated for baseline value of Hsu Bother equal to 3 is presented in this endpoint.


  33. Change From Baseline in Hsu 5-point Likert Bother Scale at Week 12 [ Time Frame: Baseline, Week 12 ]

    The Hsu 5-point Likert Bother scale is a questionnaire designed to assess the subjective bothersomeness and functional disruptiveness of nocturia. The Hsu 5 point Likert Bother Scale was scored from 0 (not at all) to 4 (extremely).

    Change from baseline in visit-specific Hsu Bother is presented in this endpoint.

    Level estimated for baseline value of Hsu Bother equal to 3 is presented in this endpoint.


  34. Change From Baseline in ISI at Week 4 [ Time Frame: Baseline, Week 4 ]

    The ISI is a 7-item questionnaire which comprises of four 'sleep-related' items and three 'wake-related' items. Each item is rated on a 0-4 scale and the total score ranges from 0 to 28 (higher score suggests more severe insomnia).

    Change from baseline in visit-specific ISI is presented in this endpoint.

    Level estimated for baseline value of ISI equal to 15 is presented in this endpoint.


  35. Change From Baseline in ISI at Week 8 [ Time Frame: Baseline, Week 8 ]

    The ISI is a 7-item questionnaire which comprises of four 'sleep-related' items and three 'wake-related' items. Each item is rated on a 0-4 scale and the total score ranges from 0 to 28 (higher score suggests more severe insomnia).

    Change from baseline in visit-specific ISI is presented in this endpoint.

    Level estimated for baseline value of ISI equal to 15 is presented in this endpoint.


  36. Change From Baseline in ISI at Week 12 [ Time Frame: Baseline, Week 12 ]

    The ISI is a 7-item questionnaire which comprises of four 'sleep-related' items and three 'wake-related' items. Each item is rated on a 0-4 scale and the total score ranges from 0 to 28 (higher score suggests more severe insomnia).

    Change from baseline in visit-specific ISI is presented in this endpoint.

    Level estimated for baseline value of ISI equal to 15 is presented in this endpoint.


  37. Change From Baseline in Mean Duration of First Undisturbed Sleep Period (FUSP) at Week 1 [ Time Frame: Baseline, Week 1 ]

    The FUSP is defined as the time in minutes from the time of going to bed to the time of first nocturnal void, or time of awakening if no void occured.

    The duration of FUSP at each visit was calculated as the average over the 3 consecutive 24-hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in FUSP are estimated using a baseline value of 180 (min).


  38. Change From Baseline in Mean Duration of FUSP at Week 4 [ Time Frame: Baseline, Week 4 ]

    The FUSP is defined as the time in minutes from the time of going to bed to the time of first nocturnal void, or time of awakening if no void occurred.

    The duration of FUSP at each visit was calculated as the average over the 3 consecutive 24-hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in FUSP are estimated using a baseline value of 180 (min).


  39. Change From Baseline in Mean Duration of FUSP at Week 8 [ Time Frame: Baseline, Week 8 ]

    The FUSP is defined as the time in minutes from the time of going to bed to the time of first nocturnal void, or time of awakening if no void occurred.

    The duration of FUSP at each visit was calculated as the average over the 3 consecutive 24-hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in FUSP are estimated using a baseline value of 180 (min).


  40. Change From Baseline in Mean Duration of FUSP at Week 12 [ Time Frame: Baseline, Week 12 ]

    The FUSP is defined as the time in minutes from the time of going to bed to the time of first nocturnal void, or time of awakening if no void occurred.

    The duration of FUSP at each visit was calculated as the average over the 3 consecutive 24-hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in FUSP are estimated using a baseline value of 180 (min).


  41. Change From Baseline in Aggregated Mean Duration of FUSP During 12 Weeks of Treatment [ Time Frame: Baseline, During 12 Weeks of Treatment ]

    The FUSP is defined as the time in minutes from the time of going to bed to the time of first nocturnal void, or time of awakening if no void occurred.

    The visit-specific means were aggregated into a mean of current and preceding visits.

    Level estimated for baseline value of mean duration of FUSP (minutes) equal to 180 is presented in this endpoint.

    The 95% credibility interval (2.5 and 97.5 percentiles of the posterior distribution) instead of confidence interval is presented for this endpoint.


  42. Change From Baseline in Nocturnal Diuresis Rate Profiles at Week 1 [ Time Frame: Baseline, Week 1 ]

    The nocturnal diuresis rate (mL/min) is calculated as the mean of the nocturnal diuresis for each of the three nights, with the single-night nocturnal diuresis calculated as the ratio of NUV to total time in bed.

    Change from baseline in visit-specific mean nocturnal diuresis (mL/min) is presented.

    Level estimated for baseline value of mean nocturnal diuresis (mL/min) equal to 1.3 is presented in this endpoint.


  43. Change From Baseline in Nocturnal Diuresis Rate Profiles at Week 12 [ Time Frame: Baseline, Week 12 ]

    The nocturnal diuresis rate (mL/min) is calculated as the mean of the nocturnal diuresis for each of the three nights, with the single-night nocturnal diuresis calculated as the ratio of NUV to total time in bed.

    Change from baseline in visit-specific mean nocturnal diuresis (mL/min) is presented.

    Level estimated for baseline value of mean nocturnal diuresis (mL/min) equal to 1.3 is presented in this endpoint.


  44. Change From Baseline in Mean NUV in Week 1 [ Time Frame: Baseline, Week 1 ]

    The NUV is defined as the total urine volume from 5 minutes after bedtime with the intention to sleep including the first void within 30 minutes of rising in the morning.

    The NUV at each visit was calculated as the average over the 3 consecutive 24-hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NUV are estimated using a baseline value of 750 (mL).


  45. Change From Baseline in Mean NUV at Week 12 [ Time Frame: Baseline, Week 12 ]

    The NUV is defined as the total urine volume from 5 minutes after bedtime with the intention to sleep including the first void within 30 minutes of rising in the morning.

    The NUV at each visit was calculated as the average over the 3 consecutive 24-hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NUV are estimated using a baseline value of 750 (mL).




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults ≥18 years of age (at the time of written consent)
  • Medical history of, or subject reported nocturia symptoms during the 6 months prior to Visit 1
  • ≥2 nocturnal voids (an average over 3 days) as documented in the 3-day e-Diary prior to Visit 2
  • The largest single voided volume must be ≥200 mL (at least 1 void ≥200 mL) as documented in the 3-day e-Diary prior to Visit 2
  • Nocturnal polyuria, defined as Nocturnal Polyuria index >33%, a ratio of Nocturnal Urine Volume in excess of 33% of total daily (24-hour) urine volume as documented in the 3-day e-Diary prior to Visit 2
  • ≥20% decrease in the nocturnal diuresis rate (mL/min) (that was recorded at Visit 2) as documented in the 3-day e-Diary prior to Visit 3

Exclusion Criteria:

  • Current diagnosis of Obstructive Sleep Apnoea (OSA)
  • Restless Legs Syndrome (RLS)
  • Bladder Outlet Obstruction (BOO) or urine flow <5 mL/s, as confirmed by uroflowmetry upon suspicion during screening prior to Visit 2
  • Urinary incontinence defined as an average of >1 episode/day in the 3-day e-Diary prior to Visit 2 (occasional urge incontinence during daytime or at night on the way to void is not necessarily exclusionary)
  • Any pelvic or lower urinary tract surgery and/or radio therapy or previous pelvic irradiation within the past 6 months prior to Visit 1. Including e.g., transurethral resection for Bladder Outlet Obstruction or Benign Prostatic Hyperplasia, hysterectomy or female incontinence procedures
  • Genito-urinary tract pathology that can in the investigator's opinion be responsible for urgency or urinary incontinence e.g., symptomatic or recurrent urinary tract infections, interstitial cystitis, bladder-related pain, chronic pelvic pain syndrome, or stone in the bladder or urethra causing symptoms
  • A history of cancer with the last date of disease activity/presence of malignancy within the last 12 months prior to Visit 1, except for adequately treated basal cell carcinoma of the skin
  • History of any neurological disease affecting bladder function or muscle strength (e.g., Multiple Sclerosis, Parkinson's, spinal cord injury, spina bifida)
  • Habitual (fluid intake >3L per day) or psychogenic polydipsia
  • Uncontrolled hypertension, as judged by the investigator
  • Uncontrolled diabetes mellitus, as judged by the investigator
  • Central or nephrogenic diabetes insipidus
  • Known history of Syndrome of Inappropriate Antidiuretic Hormone (SIADH) secretion
  • History of gastric retention
  • Suspicion or evidence of congestive heart failure, (New York Heart Association (NYHA) class II, III, IV)
  • Hyponatraemia:

    • Serum sodium level <135 mmol/L at Visit 1(re-tested, with results available within 7 days)
    • Serum sodium level <130 mmol/L at Visit 3 (re-tested, with results available within 7 days)
  • Use of any prohibited therapy listed below:

    • Current or former (within 3 months prior to screening) treatment with any other investigational medicinal product (IMP)
    • Unstable electrostimulation or behavioural bladder training program less than 3 months prior to screening (stable electrostimulation or behavioural bladder training program started at least 3 months before screening are acceptable)
    • Thiazide diuretics
    • Antiarrhythmic agents
    • V2-receptor antagonists/agonists (e.g., vaptans/desmopressin, vasopressin)
    • Loperamide
    • Botulinum toxin (cosmetic non-urological use is acceptable)
    • Valproate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03201419


Locations
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United States, Alabama
Achieve Clinical Research, LLC
Birmingham, Alabama, United States, 35216
Coastal Clinical Research, an AMR company
Mobile, Alabama, United States, 36608
United States, California
Clinical Trials Research
Lincoln, California, United States, 95648
Tri Valley Urology Medical Group
Murrieta, California, United States, 92562
San Diego Clinical Trials
San Diego, California, United States, 92120
Advanced Rx Clinical Research Group, Inc.
Westminster, California, United States, 92683
United States, Colorado
Downtown Women's Health Care
Denver, Colorado, United States, 80209
Genitourinary Surgical Consultants, P.C.
Denver, Colorado, United States, 80220
United States, Florida
South Florida Medical Research
Aventura, Florida, United States, 33180
Women's Medical Research Group, LLC
Clearwater, Florida, United States, 33759
Tampa Bay Medical Research, Inc.
Clearwater, Florida, United States, 33761
Clinical Research of South Florida
Coral Gables, Florida, United States, 33134
Avail Clinical Research, LLC
DeLand, Florida, United States, 32720
Finlay Medical Research Corp
Green Acres, Florida, United States, 33467
Pharmax Research Clinic
Miami, Florida, United States, 33126
Doctors Research Institute Corporation
Miami, Florida, United States, 33145
Sanitas Research
Miami, Florida, United States, 33155
Bayside Clinical Research LLC
New Port Richey, Florida, United States, 34655
Pines Care Research Center, Inc
Pembroke Pines, Florida, United States, 33026
Clinical Research Center of Florida
Pompano Beach, Florida, United States, 33060
Meridien Research, Inc.
Saint Petersburg, Florida, United States, 33709
United States, Indiana
American Health Network of Indiana, LLC
Avon, Indiana, United States, 46123
American Health Network of Indiana, LLC
Greenfield, Indiana, United States, 46140
United States, Massachusetts
Bay State Clinical Trials, Inc.
Watertown, Massachusetts, United States, 02472
United States, Michigan
Beyer Research
Kalamazoo, Michigan, United States, 49009
Remedica LLC
Rochester, Michigan, United States, 48307
United States, Nebraska
Quality Clinical Research Center, Inc.
Omaha, Nebraska, United States, 68114
United States, Nevada
Clinical Research Consortium, an AMR company
Las Vegas, Nevada, United States, 89119-5190
United States, New York
Mid Hudson Medical Research, PLLC
New Windsor, New York, United States, 12553
Premier Medical Group of the Hudson Valley, PC
Poughkeepsie, New York, United States, 12601
United States, North Carolina
American Health Research, Inc.
Charlotte, North Carolina, United States, 28207
Medication Management, LLC
Greensboro, North Carolina, United States, 27408
Peters Medical Research
High Point, North Carolina, United States, 27262
PMG Research of Raleigh, LLC
Raleigh, North Carolina, United States, 27609
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States, 28401
United States, Ohio
HWC Women's Research Center
Englewood, Ohio, United States, 45322
United States, Rhode Island
NECCR Primacare Research, LLC
Providence, Rhode Island, United States, 02908
United States, South Carolina
Coastal Carolina Research Center, Inc
Mount Pleasant, South Carolina, United States, 29464
PMG Research of Charleston, LLC
Mount Pleasant, South Carolina, United States, 29464
United States, Texas
MCA Research - Partner
Houston, Texas, United States, 77079
United States, Utah
Ericksen Research & Development, LLC
Clinton, Utah, United States, 84015
Advanced Research Institute
Ogden, Utah, United States, 84405
United States, Virginia
Clinical Research Associates of Tidewater, an AMR company
Norfolk, Virginia, United States, 23507
Belgium
ULB Hopital Erasme
Bruxelles, Belgium
UZ Antwerpen
Edegem, Belgium
Universitair Ziekenhuis Gent
Gent, Belgium
AZ Groeninge - Campus Vercruysselaan
Kortrijk, Belgium
UZ Leuven
Leuven, Belgium
Canada, Quebec
Ultra-Med Inc.
Pointe-Claire, Quebec, Canada
Canada
Milestone Research
London, Canada
SKDS Research Inc.
Newmarket, Canada
DIEX Recherche Quebec Inc.
Quebec, Canada
Clinique Médicale St-Louis (Recherche) inc d/b/a/ Centre de Recherche Saint-Louis
Québec, Canada
Bluewater Health-Norman Site
Sarnia, Canada
CHUS - Hôpital Fleurimont
Sherbrooke, Canada
DIEX Recherche Sherbrooke Inc.
Sherbrooke, Canada
Ferring Investigational Site
Toronto, Canada
DIEX Recherche Victoriaville Inc.
Victoriaville, Canada
Czechia
Urologie Benešov - Afimed s.r.o.
Benešov, Czechia
Fakultni nemocnice Brno, Dept of Klinika nemoci plicnich a tuberkulozy
Brno, Czechia
Krajska nemocnice Liberec, a.s.
Liberec, Czechia
Urocentrum Plzen
Plzen, Czechia
Thomayerova nemocnice, PARENT
Praha, Czechia
Germany
Gemeinschaftspraxis fuer Urologie und Andrologie
Duisburg, Germany
Urologische Gemeinschaftspraxis
Emmendingen, Germany
Klinikum Weiden, Klinik f. Urologie, Andrologie und Kinderurologie
Weiden, Germany
Hungary
Jahn Ferenc Del-pesti Korhaz es Rendelointezet
Budapest, Hungary
Synexus Magyarorszag Kft.
Budapest, Hungary
Bagoly Egeszseghaz
Kecskemet, Hungary
SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Oktatokorhaz Urologia
Nyiregyhaza, Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet
Szolnok, Hungary
Poland
Nasz Lekarz Osrodek Badan Klinicznych
Bydgoszcz, Poland
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
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Study Director: Global Clinical Compliance Ferring Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Ferring Pharmaceuticals:
Study Protocol  [PDF] July 5, 2018
Statistical Analysis Plan  [PDF] December 12, 2019

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Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03201419    
Other Study ID Numbers: 000233
2016-003851-31 ( EudraCT Number )
First Posted: June 28, 2017    Key Record Dates
Results First Posted: December 23, 2020
Last Update Posted: December 23, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Polyuria
Nocturia
Lower Urinary Tract Symptoms
Urological Manifestations
Urination Disorders
Urologic Diseases
Deamino Arginine Vasopressin
Hemostatics
Coagulants
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs