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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2005-000890-23-SE |
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Date of registration:
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02/08/2005 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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NO as an objective marker for inflammation in patients with interstitial cystitis treated with cyclosporine.
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Scientific title:
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NO as an objective marker for inflammation in patients with interstitial cystitis treated with cyclosporine. |
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Date of first enrolment:
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13/10/2005 |
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Target sample size:
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15 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-000890-23 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: no
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Email:
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Affiliation:
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Name:
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Address:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
1)Minst 18 års ålder
2)Diagnostiserad interstitiell cystit
3)Blodtryck = 140/90 mmHg
4)Serumkreatinin = 120 mikromol/L
5)Fertila kvinnor ska använda ett medicinskt acceptabelt antikonceptionsmedel
6)Signerat och daterat informerat samtycke till att delta i studien
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1)Användande av ACE-inhibitorer, angiotensin II-antagonister, kaliuminnehållande läkemedel eller andra läkemedel som inhiberar eller inducerar CYP3A4
2)Graviditet
3)Amning
4)Regelbundet intag av hypericin
5)Regelbundet intag av grapefrukt
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Interstitiell cystit
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Intervention(s)
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Trade Name: Sandimmun Neoral
Product Name: Sandimmun Neoral
Pharmaceutical Form: Capsule*
INN or Proposed INN: Ciklosporin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10, 25, 50, 100-
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Primary Outcome(s)
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Main Objective: Att utvärdera om en skillnad i inflammationsgrad i urinblåsan, vilken mäts som NO-bildning, kan upptäckas hos patienter med interstitiell cystit behandlade med ciklosporin och om denna skillnad kan relateras till en förändring av symptom och problem.
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Primary end point(s): Inflammationsgrad i urinblåsan som utvärderas med mätning av NO-bildning i blåsan.
Vi vill också korrelera en förändring i inflammationsgrad till en förändring av symptom och problem, utvärderad med ett validerat symptom-problemformulär.
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Secondary Objective:
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Secondary ID(s)
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CRC 04-100-06
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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