Grönblad-Stranberg Disease (Pseudoxanthoma Elasticum)Phase 4FIMPXE2016-01NCT04660461
Response to Oral Lansoprazole of Inorganic Pyrophosphate Levels in Patients With Grönblad-Stranberg Disease (Pseudoxanthoma Elasticum)
A Phase 4 study testing Lansoprazole 30mg in people with Grönblad-Stranberg Disease (Pseudoxanthoma Elasticum), run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.
Trial summary
Protocol code and version: FIM-PXE-2016-01 Version 1.4 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Grönblad-Stranberg Disease (Pseudoxanthoma Elasticum)
- What is being tested?
- Lansoprazole 30mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 4 Feb 2020to 24 Jun 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥18 years old
- Patients diagnosed with PXE according to 2010 criteria by PLOMP et al.
- At least, patients meet two of the following criteria:
- Retinal lesions such as Orange peel and/or Angioid streaks
- Skin lesions such as papules or yellowish plaques on the lateral face of the neck and / or flexures of the body (armpits, elbows, knees) or alterations in the skin biopsy with fragmentation and / or conglomerates of and / or calcification of the elastic fibers.
- A pathogenic mutation of the two alleles of the ABCC6 gene.
Who cannot join
- Refusal of informed consent.
- Vegetarian diet or extreme diets.
- Pregnancy or its intention during the months of the study.
- Age <18 years old
- Known hypersensitivity to "prazoles" or proton pump inhibitors.
- Intake of medications that may interfere with Lansoprazole and that cannot be withdrawn or modified in its form of administration to avoid such interference.
- Prior taking of proton pump inhibitors, except for a wash out period of 15 days if the clinical situation of the patient allows it.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Virgen de la Victoria
Málaga
Pedro Valdivieso, MD
Pedro Valdivieso
About this study
Protocol code and version: FIM-PXE-2016-01 Version 1.4
Trial title: "Response to oral lansoprazole of inorganic pyrophosphate levels in patients with Grönblad- Stranberg disease (Pseudoxanthoma Elasticum)"
Read more
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 Victoria's Universitary Hospital in Malaga and Virgen de la Macarena's Universitary Hospital in Seville.
Duration of the trial: 12 months Expected start date: December 2019 Objectives: Principal:To 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:
Selection:20 patients who meet all the criteria for inclusion and none for exclusion.
Randomisation and 1st stage: Patients will receive lansoprazole 30mg/day 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:
- Date of Birth
- Sex.
- Physical examination (anthropometry and vital signs)
- Date of first symptom.
- Date of final diagnosis
- 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).
- Skin affectation (yellowish papules or plaques on the side of the neck or other areas of flexure and lax skin).
- Vascular affectation (intermittent claudication clinic, angina and/or episode of acute myocardial infarction and/or non-embolic ischemic stroke, surgical or percutaneous revascularisation, cardiac murmur,10.)
- History of renal lithiasis, arterial hypertension, diabetes mellitus, treatments, smoking and dyslipidemia.
- Specific biochemical variables:
Inorganic pyrophosphate (IPP) NPP1 and NPP2.3: 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 patients(Competitive recruitment)
- Being tested
- Lansoprazole 30mg, Placebo
- Keywords
- Grönblad-Stranberg Disease, Pseudoxathoma Elasticum
- Medical subject headings
- Pseudoxanthoma Elasticum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lansoprazole 30mgDrug
Subjects are randomized to recieve Lansoprazole 30mg/day or placebo during 8 weeks. After a washing-out period of 15 days, subjects will receive the other treatment (cross-over design) during 8 weeks
PlaceboDrug
Subjects are randomized to recieve Lansoprazole 30mg/day or placebo during 8 weeks. After a washing-out period of 15 days, subjects will receive the other treatment (cross-over design) during 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1. Randomized placebo-controlled, parallel-group study, crossover-design | Experimental | Not described Receives: Drug: Lansoprazole 30mg; Drug: Placebo |
| 2. Randomized placebo-controlled, parallel-group study, crossover-design | Experimental | Not described Receives: Drug: Lansoprazole 30mg; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in PPi,NPP1-3 and TNAP
changes in plasma PPi, and the main molecules that regulate it (NPP1-3, TNAP) after oral administration of lansoprazole in patients diagnosed with PXE
Measured: 8 weeks, 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start4 Feb 2020
- Primary completion24 Jun 2021 (estimated)
- Study completion24 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for Grönblad-Stranberg Disease (Pseudoxanthoma Elasticum)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Clinical trial, double blind, placebo controlled, randomized and crossed groups of patients in two stages, that receive a treatment with lansoprazole and placebo during 8 weeks with wash-ot period of 15 days
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04660461
- Sponsor's protocol ID
- EudraCT 2016-004021-16
- Other IDs
- FIM-PXE-2016-01
- Acronym
- FIMPXE2016-01
- Status last verified
- Nov 2020
- First submitted
- 3 Dec 2020
- Last updated
- 9 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Le Saux O, Urban Z, Tschuch C, Csiszar K, Bacchelli B, Quaglino D, Pasquali-Ronchetti I, Pope FM, Richards A, Terry S, Bercovitch L, de Paepe A, Boyd CD. Mutations in a gene encoding an ABC transporter cause pseudoxanthoma elasticum. Nat Genet. 2000 Jun;25(2):223-7. doi: 10.1038/76102.
PubMed 10835642Scheffer GL, Hu X, Pijnenborg AC, Wijnholds J, Bergen AA, Scheper RJ. MRP6 (ABCC6) detection in normal human tissues and tumors. Lab Invest. 2002 Apr;82(4):515-8. doi: 10.1038/labinvest.3780444. No abstract available.
PubMed 11950908Brown SJ, Talks SJ, Needham SJ, Taylor AE. Pseudoxanthoma elasticum: biopsy of clinically normal skin in the investigation of patients with angioid streaks. Br J Dermatol. 2007 Oct;157(4):748-51. doi: 10.1111/j.1365-2133.2007.08076.x. Epub 2007 Jul 30.
PubMed 17666106Schroder F, Hausser I, Szliska C, Lawall H, Diehm C. Images in vascular medicine. Pseudoxanthoma elasticum: under-recognized cause of early onset peripheral arterial disease? Vasc Med. 2006 Nov;11(4):266-7. doi: 10.1177/1358863x06075186. No abstract available.
PubMed 17390553Fabre B, Bayle P, Bazex J, Durand D, Lamant L, Chassaing N. Pseudoxanthoma elasticum and nephrolithiasis. J Eur Acad Dermatol Venereol. 2005 Mar;19(2):212-5. doi: 10.1111/j.1468-3083.2005.01007.x.
PubMed 15752294Chassaing N, Martin L, Calvas P, Le Bert M, Hovnanian A. Pseudoxanthoma elasticum: a clinical, pathophysiological and genetic update including 11 novel ABCC6 mutations. J Med Genet. 2005 Dec;42(12):881-92. doi: 10.1136/jmg.2004.030171. Epub 2005 May 13.
PubMed 15894595Laube S, Moss C. Pseudoxanthoma elasticum. Arch Dis Child. 2005 Jul;90(7):754-6. doi: 10.1136/adc.2004.062075.
PubMed 15970621Li Q, Jiang Q, Pfendner E, Varadi A, Uitto J. Pseudoxanthoma elasticum: clinical phenotypes, molecular genetics and putative pathomechanisms. Exp Dermatol. 2009 Jan;18(1):1-11. doi: 10.1111/j.1600-0625.2008.00795.x. Epub 2008 Oct 22.
PubMed 19054062Lebwohl M, Schwartz E, Lemlich G, Lovelace O, Shaikh-Bahai F, Fleischmajer R. Abnormalities of connective tissue components in lesional and non-lesional tissue of patients with pseudoxanthoma elasticum. Arch Dermatol Res. 1993;285(3):121-6. doi: 10.1007/BF01112912.
PubMed 8503691Plomp AS, Toonstra J, Bergen AA, van Dijk MR, de Jong PT. Proposal for updating the pseudoxanthoma elasticum classification system and a review of the clinical findings. Am J Med Genet A. 2010 Apr;152A(4):1049-58. doi: 10.1002/ajmg.a.33329.
PubMed 20358627Quaglino D, Sartor L, Garbisa S, Boraldi F, Croce A, Passi A, De Luca G, Tiozzo R, Pasquali-Ronchetti I. Dermal fibroblasts from pseudoxanthoma elasticum patients have raised MMP-2 degradative potential. Biochim Biophys Acta. 2005 Jun 30;1741(1-2):42-7. doi: 10.1016/j.bbadis.2004.09.012. Epub 2004 Oct 8.
PubMed 15955448Pasquali-Ronchetti I, Garcia-Fernandez MI, Boraldi F, Quaglino D, Gheduzzi D, De Vincenzi Paolinelli C, Tiozzo R, Bergamini S, Ceccarelli D, Muscatello U. Oxidative stress in fibroblasts from patients with pseudoxanthoma elasticum: possible role in the pathogenesis of clinical manifestations. J Pathol. 2006 Jan;208(1):54-61. doi: 10.1002/path.1867.
PubMed 16261549Quaglino D, Boraldi F, Barbieri D, Croce A, Tiozzo R, Pasquali Ronchetti I. Abnormal phenotype of in vitro dermal fibroblasts from patients with Pseudoxanthoma elasticum (PXE). Biochim Biophys Acta. 2000 Apr 15;1501(1):51-62. doi: 10.1016/s0925-4439(00)00007-7.
PubMed 10727849Ronchetti I, Boraldi F, Annovi G, Cianciulli P, Quaglino D. Fibroblast involvement in soft connective tissue calcification. Front Genet. 2013 Mar 5;4:22. doi: 10.3389/fgene.2013.00022. eCollection 2013.
PubMed 23467434Boraldi F, Annovi G, Bartolomeo A, Quaglino D. Fibroblasts from patients affected by Pseudoxanthoma elasticum exhibit an altered PPi metabolism and are more responsive to pro-calcifying stimuli. J Dermatol Sci. 2014 Apr;74(1):72-80. doi: 10.1016/j.jdermsci.2013.12.008. Epub 2014 Jan 2.
PubMed 24461675
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response to Oral Lansoprazole of Inorganic Pyrophosphate Levels in Patients With Grönblad-Stranberg Disease (Pseudoxanthoma Elasticum)
- ClinicalTrials.gov ID
- NCT04660461
- Acronym / sponsor ID
- FIMPXE2016-01 / EudraCT 2016-004021-16
- Keywords
- Grönblad-Stranberg Disease, Pseudoxathoma Elasticum
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludUniversity, hospital or other
- Study start
- 4 Feb 2020 (actual)
- Primary completion
- 24 Jun 2021 (estimated)
- Study completion
- 24 Jun 2021 (estimated)
- First posted
- 9 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Protocol code and version: FIM-PXE-2016-01 Version 1.4
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 Victoria's Universitary Hospital in Malaga and Virgen de la Macarena's Universitary Hospital in Seville.
Duration of the trial: 12 months Expected start date: December 2019 Objectives: Principal:To 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:
Selection:20 patients who meet all the criteria for inclusion and none for exclusion.
Randomisation and 1st stage: Patients will receive lansoprazole 30mg/day 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:
- Date of Birth
- Sex.
- Physical examination (anthropometry and vital signs)
- Date of first symptom.
- Date of final diagnosis
- 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).
- Skin affectation (yellowish papules or plaques on the side of the neck or other areas of flexure and lax skin).
- Vascular affectation (intermittent claudication clinic, angina and/or episode of acute myocardial infarction and/or non-embolic ischemic stroke, surgical or percutaneous revascularisation, cardiac murmur,10.)
- History of renal lithiasis, arterial hypertension, diabetes mellitus, treatments, smoking and dyslipidemia.
- Specific biochemical variables:
Inorganic pyrophosphate (IPP) NPP1 and NPP2.3: 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 patients(Competitive recruitment)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Clinical trial, double blind, placebo controlled, randomized and crossed groups of patients in two stages, that receive a treatment with lansoprazole and placebo during 8 weeks with wash-ot period of 15 days
| Arm | Type | Receives |
|---|---|---|
| 1. Randomized placebo-controlled, parallel-group study, crossover-design | Experimental | Drug: Lansoprazole 30mg, Drug: Placebo |
| 2. Randomized placebo-controlled, parallel-group study, crossover-design | Experimental | Drug: Lansoprazole 30mg, Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients ≥18 years old
- Patients diagnosed with PXE according to 2010 criteria by PLOMP et al.
- At least, patients meet two of the following criteria:
Key exclusion criteria (7 listed)
- Refusal of informed consent.
- Vegetarian diet or extreme diets.
- Pregnancy or its intention during the months of the study.
- Age <18 years old
- Known hypersensitivity to "prazoles" or proton pump inhibitors.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lansoprazole 30mgSubjects are randomized to recieve Lansoprazole 30mg/day or placebo during 8 weeks. After a washing-out period of 15 days, subjects will receive the other treatment (cross-over design) during 8 weeks | Drug | 1. Randomized placebo-controlled, parallel-group study, crossover-design, 2. Randomized placebo-controlled, parallel-group study, crossover-design |
| PlaceboSubjects are randomized to recieve Lansoprazole 30mg/day or placebo during 8 weeks. After a washing-out period of 15 days, subjects will receive the other treatment (cross-over design) during 8 weeks | Drug | 1. Randomized placebo-controlled, parallel-group study, crossover-design, 2. Randomized placebo-controlled, parallel-group study, crossover-design |
Primary outcome
Changes in PPi,NPP1-3 and TNAP
Time frame: 8 weeks, 18 weeks
changes in plasma PPi, and the main molecules that regulate it (NPP1-3, TNAP) after oral administration of lansoprazole in patients diagnosed with PXE
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2020.
- Background: PubMed 10835642Le Saux O, Urban Z, Tschuch C, Csiszar K, Bacchelli B, Quaglino D, Pasquali-Ronchetti I, Pope FM, Richards A, Terry S, Bercovitch L, de Paepe A, Boyd CD. Mutations in a gene encoding an ABC transporter cause pseudoxanthoma elasticum. Nat Genet. 2000 Jun;25(2):223-7. doi: 10.1038/76102.
- Background: PubMed 11950908Scheffer GL, Hu X, Pijnenborg AC, Wijnholds J, Bergen AA, Scheper RJ. MRP6 (ABCC6) detection in normal human tissues and tumors. Lab Invest. 2002 Apr;82(4):515-8. doi: 10.1038/labinvest.3780444. No abstract available.
- Background: PubMed 17666106Brown SJ, Talks SJ, Needham SJ, Taylor AE. Pseudoxanthoma elasticum: biopsy of clinically normal skin in the investigation of patients with angioid streaks. Br J Dermatol. 2007 Oct;157(4):748-51. doi: 10.1111/j.1365-2133.2007.08076.x. Epub 2007 Jul 30.
- Background: PubMed 17390553Schroder F, Hausser I, Szliska C, Lawall H, Diehm C. Images in vascular medicine. Pseudoxanthoma elasticum: under-recognized cause of early onset peripheral arterial disease? Vasc Med. 2006 Nov;11(4):266-7. doi: 10.1177/1358863x06075186. No abstract available.
- Background: PubMed 15752294Fabre B, Bayle P, Bazex J, Durand D, Lamant L, Chassaing N. Pseudoxanthoma elasticum and nephrolithiasis. J Eur Acad Dermatol Venereol. 2005 Mar;19(2):212-5. doi: 10.1111/j.1468-3083.2005.01007.x.
- Background: PubMed 15894595Chassaing N, Martin L, Calvas P, Le Bert M, Hovnanian A. Pseudoxanthoma elasticum: a clinical, pathophysiological and genetic update including 11 novel ABCC6 mutations. J Med Genet. 2005 Dec;42(12):881-92. doi: 10.1136/jmg.2004.030171. Epub 2005 May 13.
- Background: PubMed 15970621Laube S, Moss C. Pseudoxanthoma elasticum. Arch Dis Child. 2005 Jul;90(7):754-6. doi: 10.1136/adc.2004.062075.
- Background: PubMed 19054062Li Q, Jiang Q, Pfendner E, Varadi A, Uitto J. Pseudoxanthoma elasticum: clinical phenotypes, molecular genetics and putative pathomechanisms. Exp Dermatol. 2009 Jan;18(1):1-11. doi: 10.1111/j.1600-0625.2008.00795.x. Epub 2008 Oct 22.
- Background: PubMed 8503691Lebwohl M, Schwartz E, Lemlich G, Lovelace O, Shaikh-Bahai F, Fleischmajer R. Abnormalities of connective tissue components in lesional and non-lesional tissue of patients with pseudoxanthoma elasticum. Arch Dermatol Res. 1993;285(3):121-6. doi: 10.1007/BF01112912.
- Background: PubMed 20358627Plomp AS, Toonstra J, Bergen AA, van Dijk MR, de Jong PT. Proposal for updating the pseudoxanthoma elasticum classification system and a review of the clinical findings. Am J Med Genet A. 2010 Apr;152A(4):1049-58. doi: 10.1002/ajmg.a.33329.
- Background: PubMed 15955448Quaglino D, Sartor L, Garbisa S, Boraldi F, Croce A, Passi A, De Luca G, Tiozzo R, Pasquali-Ronchetti I. Dermal fibroblasts from pseudoxanthoma elasticum patients have raised MMP-2 degradative potential. Biochim Biophys Acta. 2005 Jun 30;1741(1-2):42-7. doi: 10.1016/j.bbadis.2004.09.012. Epub 2004 Oct 8.
- Background: PubMed 16261549Pasquali-Ronchetti I, Garcia-Fernandez MI, Boraldi F, Quaglino D, Gheduzzi D, De Vincenzi Paolinelli C, Tiozzo R, Bergamini S, Ceccarelli D, Muscatello U. Oxidative stress in fibroblasts from patients with pseudoxanthoma elasticum: possible role in the pathogenesis of clinical manifestations. J Pathol. 2006 Jan;208(1):54-61. doi: 10.1002/path.1867.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lansoprazole 30mg in people with Grönblad-Stranberg Disease (Pseudoxanthoma Elasticum), run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gloria Luque (951291977, gloria.luque@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in PPi,NPP1-3 and TNAP (time frame: 8 weeks, 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04660461, which also lists 35 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2020.