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Sponsors and Collaborators: |
Tripep AB Kringle Pharma, Inc. |
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Information provided by: | Tripep AB |
ClinicalTrials.gov Identifier: | NCT00797706 |
The purpose of this study is to evaluate if the investigational medicinal product CHRONSEAL intended for future treatment of chronic venous leg ulcers has an ulcer size reduction effect and if it is safe and tolerated when administered to individuals suffering from venous leg ulcers.
Condition | Intervention | Phase |
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Chronic Venous Leg Ulcers |
Drug: CHRONSEAL |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Efficacy and Safety of CHRONSEAL® (5-Amino-Acid Deleted Recombinant Human Hepatocyte Growth Factor (KP-dHGF)), in Subjects With Venous Leg Ulcers. A Double-Blind, Vehicle Controlled, Parallel Groups, Randomized, Dose Range, Proof of Concept Study. |
Estimated Enrollment: | 75 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Vehicle: Placebo Comparator |
Drug: CHRONSEAL
Cream (1.4/2.8 g depending on ulcer size) topical administration, every 2nd day at 3 occasions
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Low dose: Experimental |
Drug: CHRONSEAL
Cream (1.4/2.8 g depending on ulcer size) topical administration, every 2nd day at 3 occasions
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High dose: Experimental |
Drug: CHRONSEAL
Cream (1.4/2.8 g depending on ulcer size) topical administration, every 2nd day at 3 occasions
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Ages Eligible for Study: | 40 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria (Run-in period):
Exclusion criteria (Run-in period)
Concomitant systemic treatment within 14 days prior to start of study medication with any of the following:
• Corticosteroids or immunosuppressives
• Continuous treatment with NSAIDs or aspirin (aspirin above 75 mg)
Concomitant topical treatment within 14 days prior to start of study medication with any of the following:
• NSAIDs, aspirin
Inclusion criteria (Randomization)
Exclusion criteria (Randomization)
1.& 2. = Run-in period criteria 1. & 2.
3. Subject having to the discretion of the investigator clinically significant findings on vital signs or laboratory values.
4.-10. = Run-in period criteria 6., 7., 8., 11., 12., 13., & 14
Norway | |
Medi 3 Innlandet AS, Department Hamar | Recruiting |
Hamar, Norway, 2317 | |
Contact: Hans Olav Høivik, MD +47 62 52 05 60 hans.olav.hoivik@medi3-innlandet.nhn.no | |
Principal Investigator: Hans Olav Høivik, MD | |
Colosseumklinikken | Recruiting |
Oslo, Norway, 0369 | |
Contact: Dagfinn Aarskog, MD +47 23 19 60 40 aarskog@colosseumlegene.no | |
Principal Investigator: Dagfinn Aarskog, MD | |
Medi3 Innlandet AS, Department Elverum | Recruiting |
Elverum, Norway, 2402 | |
Contact: Sigbjørn Elle, MD +47 62 42 84 00 sigbjorn.elle@medi3-innlandet.nhn.no | |
Principal Investigator: Sigbjørn Elle, MD | |
Hudavdelingen Helse, Førde | Recruiting |
Førde, Norway, 6807 | |
Contact: Øystein Vatne, MD +47 57 83 93 66 oystein.vatne@helse-forde.no | |
Principal Investigator: Øystein Vatne, MD | |
Sweden | |
Department of Dermatology, Norrlands University hospital | Not yet recruiting |
Umeå, Sweden, 901 85 | |
Contact: Anette Laestadius, MD +46 90 785 20 38 Anette.Laestadius@vll.se | |
Principal Investigator: Anette Laestadius, MD | |
Department of Dermatology, Lund University hospital | Not yet recruiting |
Lund, Sweden, 221 85 | |
Contact: Katarina Lundqvist, PhD, MD +46 46 17 21 13 katarina.lundqvist@skane.se | |
Principal Investigator: Katarina Lundqvist, PhD, MD | |
Department of Medical Sciences, Section of Dermatology and Venereology, Uppsala University hospital | Not yet recruiting |
Uppsala, Sweden, 751 05 | |
Contact: Ola Rollman, PhD, MD +46 18 611 50 86 ola.rollman@medsci.uu.se | |
Principal Investigator: Ola Rollman, PhD, MD | |
Department of Dermatology and Infectious diseases | Not yet recruiting |
Halmstad, Sweden, 301 85 | |
Contact: Karin Andersson, MD +46 35 13 42 50 karin.andersson@lthalland.se | |
Principal Investigator: Karin Andersson, MD |
Principal Investigator: | Hans Olav Høivik, MD | Medi 3 Innlandet AS, avd Hamar |
Principal Investigator: | Karin Andersson, MD | Halland County Council, Department of Dermatology and Infectious diseases, Halmstad, Sweden |
Study Chair: | Jan Apelqvist, Assoc. Prof., PhD, MD | Department of Endocrinology, University Hospital Malmö, |
Responsible Party: | Tripep AB ( Jan Nilsson/CEO ) |
Study ID Numbers: | CS-201, EudraCT No. 2007-002695-34 |
Study First Received: | November 24, 2008 |
Last Updated: | December 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00797706 History of Changes |
Health Authority: | Norway: Norwegian Medicines Agency; Sweden: Medical Products Agency |
Skin Diseases Ulcer Mitogens Skin Ulcer Leg Ulcer |
Pathologic Processes Skin Diseases Ulcer Skin Ulcer Leg Ulcer |