Desmopressin Melt Therapy in Nocturnal Polyuria Patients: Pharmacodynamic Study
This study is not yet open for participant recruitment.
Verified February 2013 by University Hospital, Ghent
Sponsor:
University Hospital, Ghent
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01439997
First received: September 14, 2011
Last updated: February 1, 2013
Last verified: February 2013
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Purpose
The objective of this study is to find out what the pharmacodynamic (PD) characteristics of desmopressin melt are in nocturia patients (compared to healthy volunteers and children). The main questions the investigators want to answer are:
- Are differences related to the pathophysiological factors involved in nocturia?
- Are there age/gender/size differences?
- Can the investigators identify patients who are likely to develop hyponatraemia?
- Can the investigators individualize treatment and reduce risk for hyponatraemia?
The patient will be given a prescription to buy Minirin Melt 60µg at the local pharmacy. During 30 days, the patient has to take Minirin Melt 60µg in the evening before going to bed.
There are two groups of patients:
Group A:
Patients that still have to undergo an evaluation phase, according to standard procedures (e.g. osmolality test, blood sample). This procedure is not a part of this study. The study starts when the 1st Minirin Melt tablet has been taken (= day 1).
Group B:
This group already went through the evaluation phase (by participation to study 1 or study 3 as mentioned above) and they have been prescribed Minirin Melt 60 µg ambulatory.
The study starts when the patients takes his first prescribed Minirin Melt tablet:
- On day 3 and day 7 a blood sample will be taken at the UZ Ghent for safety control (Na+, K+, creatinin, osmolality = good clinical practice guideline). These first 2 visits (day 3 and day 7) are standard procedure. If the patient is at high risk for side effects, blood has to be taken during the first 7 days.
- On day 3 the patient has to give a urine sample.
- Patients have to fill out a frequency/volume chart during the first 14 days.
- On day 30, a 3rd blood sample will be taken
| Condition | Intervention | Phase |
|---|---|---|
|
Nocturia |
Drug: Desmopressin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacodynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Desmopressin Melt Therapy in Nocturnal Polyuria Patients: Pharmacodynamic Study |
Resource links provided by NLM:
Further study details as provided by University Hospital, Ghent:
Primary Outcome Measures:
- Blood samples for plasma concentration of Na+, K+, creatinin, osmolality (safety profile)at day 3. [ Time Frame: At day 3 after first desmopressin intake. ] [ Designated as safety issue: No ]
- Urine sample for urine concentration of Na+, K+, creatinin and osmolality [ Time Frame: At day 3 ] [ Designated as safety issue: Yes ]
- Area Under Curve (AUC) frequency/volume chart during the first 14 days [ Time Frame: Every day during the first 14 days. ] [ Designated as safety issue: Yes ]
- The decrease of number of nocturnal micturition episodes. [ Time Frame: At day 0 ] [ Designated as safety issue: No ]Questionnaires at day 0 to evaluate the decrease of number of nocturnal micturition episodes.
- The decrease of the number of nocturnal micturition episodes. [ Time Frame: At day 30 ] [ Designated as safety issue: No ]Questionnaires at day 30 to evaluate the number of nocturnal micturition episodes
- Registration of number of side effects at day 3. [ Time Frame: At day 3 ] [ Designated as safety issue: Yes ]
- Blood samples for plasma concentration of Na+, K+, creatinin, osmolality (safety profile)at day 7. [ Time Frame: At day 7 after first desmopressin intake ] [ Designated as safety issue: No ]
- Blood samples for plasma concentration of Na+, K+, creatinin, osmolality (safety profile)at day 30. [ Time Frame: At day 30 after first desmopressin intake ] [ Designated as safety issue: No ]
- Registration of number of side effects at day 7 [ Time Frame: At day 7 ] [ Designated as safety issue: Yes ]
- Registration of number of side effects at day 30. [ Time Frame: At day 30 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 50 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Desmopressin Melt Therapy in Nocturnal Polyuria Patients |
Drug: Desmopressin
Administration of minirin melt 60 µg: desmopressin (acetate) 60 µg oral lyophilisate.
Other Name: Minirin Melt 60 µg
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- written informed consent prior to the performance of any study-related activity
- patients, men and women, 18 years and older, with an average of ≥ 2 nocturnal voids per night
- evidence for nocturnal polyuria (nocturnal urine volume >33% of total volume over 24h), determined on frequency/volume chart
- Diuresis <2.5L
Exclusion Criteria:
- hypersensitivity/anaphylactic reaction on desmopressin or one of the other substances
- pregnancy
- genitourinary tract pathology (infection, tumor,...)
- urolithiasis
- suspicion or evidence of cardiac failure
- moderate to severe renal insufficiency (creatinin clearance < 60 ml/min)
- psychogenic or habitual polydipsia
- hyponatraemia or predisposition for hyponatraemia
- diabetes insipidus
- syndrome of inadequate ADH production
- suspicion or evidence of liver failure
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01439997
Contacts
| Contact: An-Sofie Goessaert, MD, PhD | ansofie.goessaert@ugent.be |
Locations
| Belgium | |
| University Hospital Ghent | Not yet recruiting |
| Ghent, Belgium, 9000 | |
| Principal Investigator: Karel Everaert, MD, PhD | |
| Sub-Investigator: An-Sofie Goessaert, MD | |
| Sub-Investigator: Johan Vande Walle, MD, PhD | |
Sponsors and Collaborators
University Hospital, Ghent
Investigators
| Principal Investigator: | Karel Everaert, MD, PhD | University Hospital, Ghent |
More Information
Additional Information:
No publications provided
| Responsible Party: | University Hospital, Ghent |
| ClinicalTrials.gov Identifier: | NCT01439997 History of Changes |
| Other Study ID Numbers: | 2011/567 |
| Study First Received: | September 14, 2011 |
| Last Updated: | February 1, 2013 |
| Health Authority: | Belgium: Ethics Committee Belgium: Federal Agency for Medicinal Products and Health Products |
Keywords provided by University Hospital, Ghent:
|
Nocturnal polyuria |
Additional relevant MeSH terms:
|
Nocturia Polyuria Urological Manifestations Signs and Symptoms Urination Disorders Urologic Diseases Deamino Arginine Vasopressin Antidiuretic Agents |
Natriuretic Agents Physiological Effects of Drugs Pharmacologic Actions Hemostatics Coagulants Hematologic Agents Therapeutic Uses Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 22, 2013