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Vasopressin Analog

desmopressin melt 100 μg for Nocturia

Phase 3

Waitlist Available

Research Sponsored by Ferring Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up - week 3 to day 1 (baseline), days 29, 57, 113 and 169

Awards & highlights

All Individual Drugs Already Approved

Pivotal Trial

Summary

The purpose of this study is to investigate the efficacy and safety of several doses of the melt formulation of desmopressin in a broad population of adult patients with nocturia.

Eligible Conditions

Nocturia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ - week 3 to day 1 (baseline), days 29, 57, 113 and 169

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~- week 3 to day 1 (baseline), days 29, 57, 113 and 169

This trial's timeline: 3 weeks for screening, Varies for treatment, and - week 3 to day 1 (baseline), days 29, 57, 113 and 169 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part I: Change From Baseline in Mean Number of Nocturnal Voids at Week 4

Part I: Percentage of Participants With Greater Than 33 Percent Reduction From Baseline in Mean Number of Nocturnal Voids at Week 4

Secondary study objectives

Part I: Change From Baseline in Initial Period of Undisturbed Sleep at Week 4

Part I: Change From Baseline in Quality of Life Assessed by The International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N) at Week 4

Part I: Change From Baseline in Quality of Sleep as Assessed by the Global Score of the Pittsburgh Sleep Quality Index (PSQI) at Week 4

+7 more

Side effects data

From 2008 Phase 3 trial • 799 Patients • NCT00477490

35%

Dry mouth

10%

Headache

Diarrhoea

Nausea

Nasopharyngitis

Upper respiratory tract infection

Constipation

Urinary tract infection

Abdominal pain upper

Hypertension

Pain

Dyspepsia

Blood glucose increased

Hyponatraemia

Pollakiuria

100%

80%

60%

40%

20%

Study treatment Arm

Part II: Placebo to Desmopressin Melt 25 μg

Part II: Placebo to Desmopressin Melt 100 μg

Part II: Desmopressin Melt 50 μg

Part I: Desmopressin Melt 10 μg

Part I: Desmopressin Melt 25 μg

Part I: Desmopressin Melt 100 μg

Part II: Desmopressin Melt 10 μg

Part II: Desmopressin Melt 25 μg

Part II: Placebo to Desmopressin Melt 10 μg

Part II: Placebo to Desmopressin Melt 50 μg

Part I: Placebo

Part II: Desmopressin Melt 100 μg

Part I: Desmopressin Melt 50 μg

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: desmopressin melt 50 μgExperimental Treatment1 Intervention

Participants took desmopressin melt 50 μg for 28 days to complete part 1 of the study. Participants continued on this dose in part 2 of the study for between 1 and 6 months (until the database for part 1 was locked and treatment was unblinded).

Group II: desmopressin melt 25 μgExperimental Treatment1 Intervention

Participants took desmopressin melt 25 μg for 28 days to complete part 1 of the study. Participants continued on this dose in part 2 of the study for between 1 and 6 months (until the database for part 1 was locked and treatment was unblinded).

Group III: desmopressin melt 100 μgExperimental Treatment1 Intervention

Participants will take desmopressin melt 100 μg for 28 days to complete part 1 of the study. Participants will continue on this dose in part 2 of the study for between 1-6 months (until the database for part 1 is locked and treatment is unblinded).

Group IV: desmopressin melt 10 μgExperimental Treatment1 Intervention

Participants took desmopressin melt 10 μg for 28 days to complete part 1 of the study. Participants continued on this dose in part 2 of the study for between 1 and 6 months (until the database for part 1 was locked and treatment was unblinded).

Group V: PlaceboPlacebo Group1 Intervention

Participants took a placebo 'melt' for 28 days to complete part 1 of the study. In part 2, placebo patients were randomized to one of the other 4 treatment arms based on assignments predetermined at the initial randomization, to receive active desmopressin melt for between 1 and 6 months (until the database for part 1 was locked and treatment was unblinded).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Desmopressin

FDA approved

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