Ignite Creation Date:
2024-05-06 @ 3:32 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04660461
Status:
UNKNOWN
Last Update Posted:
2020-12-09
First Post:
2020-12-03
Brief Title:
Response to Oral Lansoprazole of Inorganic Pyrophosphate Levels in Patients With Grönblad-Stranberg Disease Pseudoxanthoma Elasticum
Sponsor:
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Organization:
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Study Overview
Official Title:
Response to Oral Lansoprazole of Inorganic Pyrophosphate Levels in Patients With Grönblad-Stranberg Disease Pseudoxanthoma Elasticum
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FIMPXE2016-01
Brief Summary:
Protocol code and version FIM-PXE-2016-01 Version 14
Trial title Response to oral lansoprazole of inorganic pyrophosphate levels in patients with Grönblad- Stranberg disease Pseudoxanthoma Elasticum
Trial design Double-blind placebo-controlled randomised two-stage crossover clinical trial with each patient serving as their own control and reducing the number of patients to confirm our hypothesis
Principal Investigator Dr Pedro Valdivielso Felices Participating centres Virgen de la Victorias Universitary Hospital in Malaga and Virgen de la Macarenas Universitary Hospital in Seville
Duration of the trial 12 months Expected start date December 2019 Objectives PrincipalTo verify the changes in plasma PPi and the main molecules that regulate it NPP1-3 TNAP after oral administration of lansoprazole in patients diagnosed with PXE
Description of treatment
Selection20 patients who meet all the criteria for inclusion and none for exclusion
Randomisation and 1st stage Patients will receive lansoprazole 30mgday or their placebo for 8 weeks
Wash-out After 8 weeks all treatment will be suspended for 15 days 2nd stage crossed Treatment is crossed each patient serves as his or her own control
Evaluation variables
1 Date of Birth
2 Sex
3 Physical examination anthropometry and vital signs
4 Date of first symptom
5 Date of final diagnosis
6 Ocular affectation orange peel skin complete striae angioides lucentis corrected visual acuity cataracts intraocular pressure fundus vascular flow optic nerve drusen retinal atrophy neovascular membranes macular thickness colloid thickness
7 Skin affectation yellowish papules or plaques on the side of the neck or other areas of flexure and lax skin
8 Vascular affectation intermittent claudication clinic angina andor episode of acute myocardial infarction andor non-embolic ischemic stroke surgical or percutaneous revascularisation cardiac murmur10
9 History of renal lithiasis arterial hypertension diabetes mellitus treatments smoking and dyslipidemia
10 Specific biochemical variables
Inorganic pyrophosphate IPP NPP1 and NPP23 activity and mass concentration of the enzyme Non-specific tissue alkaline phosphatase NTAP and PHA Osteocalcin To check possible side effects on bone metabolism 5-Nucleotidas General analytical parameters haemoglobin haematocrit MVC MHC platelets neutrophils prothrombin activity TPTA thrombin time ferritin PCR glycaemia urea creatinine cholesterol triglycerides HDL cholesterol LDL cholesterol uric acid calcium phosphorus alkaline phosphatase PTH By means of routine clinical laboratory techniques Number of patients TOTAL 20 patientsCompetitive recruitment
Trial title Response to oral lansoprazole of inorganic pyrophosphate levels in patients with Grönblad- Stranberg disease Pseudoxanthoma Elasticum
Trial design Double-blind placebo-controlled randomised two-stage crossover clinical trial with each patient serving as their own control and reducing the number of patients to confirm our hypothesis
Principal Investigator Dr Pedro Valdivielso Felices Participating centres Virgen de la Victorias Universitary Hospital in Malaga and Virgen de la Macarenas Universitary Hospital in Seville
Duration of the trial 12 months Expected start date December 2019 Objectives PrincipalTo verify the changes in plasma PPi and the main molecules that regulate it NPP1-3 TNAP after oral administration of lansoprazole in patients diagnosed with PXE
Description of treatment
Selection20 patients who meet all the criteria for inclusion and none for exclusion
Randomisation and 1st stage Patients will receive lansoprazole 30mgday or their placebo for 8 weeks
Wash-out After 8 weeks all treatment will be suspended for 15 days 2nd stage crossed Treatment is crossed each patient serves as his or her own control
Evaluation variables
1 Date of Birth
2 Sex
3 Physical examination anthropometry and vital signs
4 Date of first symptom
5 Date of final diagnosis
6 Ocular affectation orange peel skin complete striae angioides lucentis corrected visual acuity cataracts intraocular pressure fundus vascular flow optic nerve drusen retinal atrophy neovascular membranes macular thickness colloid thickness
7 Skin affectation yellowish papules or plaques on the side of the neck or other areas of flexure and lax skin
8 Vascular affectation intermittent claudication clinic angina andor episode of acute myocardial infarction andor non-embolic ischemic stroke surgical or percutaneous revascularisation cardiac murmur10
9 History of renal lithiasis arterial hypertension diabetes mellitus treatments smoking and dyslipidemia
10 Specific biochemical variables
Inorganic pyrophosphate IPP NPP1 and NPP23 activity and mass concentration of the enzyme Non-specific tissue alkaline phosphatase NTAP and PHA Osteocalcin To check possible side effects on bone metabolism 5-Nucleotidas General analytical parameters haemoglobin haematocrit MVC MHC platelets neutrophils prothrombin activity TPTA thrombin time ferritin PCR glycaemia urea creatinine cholesterol triglycerides HDL cholesterol LDL cholesterol uric acid calcium phosphorus alkaline phosphatase PTH By means of routine clinical laboratory techniques Number of patients TOTAL 20 patientsCompetitive recruitment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FIM-PXE-2016-01 | OTHER | FIMABIS | None |