Response to oral lansoprazole in patients with Pseudoxanthoma Elasticum

Response to oral lansoprazole in inorganic pyrophosphate levels in patients with Grönblad-Stranberg disease (Pseudoxanthoma Elasticum) - FIM-PXE-2016-01

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004021-16-ES

Enrollment

Registered

2017-03-10

Start date

2018-10-31

Completion date

Unknown

Last updated

2019-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Grönblad-Stranberg disease (Pseudoxanthoma Elasticum) MedDRA version: 19.1 Level: PT Classification code 10037150 Term: Pseudoxanthoma elasticum System Organ Class: 10010331 - Congenital, familial and genetic disorders

Interventions

Trade Name: Lansoprazole Pharmaceutical Form: Capsule INN or Proposed INN: Lansolprazole CAS Number: 103577-45-3 Other descriptive name: LANSOPRAZOLE Concentration unit: mg milligram(s) Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.- Patients =18 years diagnosed of PXE according to the 2010 criteria of PLOMP et al (10) in follow-up at the Internal Medicine Consultation of the Virgen de la Victoria Hospital in Málaga and at the Internal Medicine Consultation of the Hospital Virgen de la Macarena de Sevilla and that meet at least two of the following criteria: A. Retinal lesions peau d'orange type and / or angioid streaks. B. Skin lesions consisting of papules or yellowish plaques on the lateral side of the neck and / or body flexures (axilary folds, elbows, knees) or alterations in the skin biopsy with fragmentation and / or conglomerates of and / or elastic fiber calcification. C. A pathogenic mutation of the two alleles of the ABCC6 gene. 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: 1.- Refuse to give informed consent. 2.- Vegetarian diet or extreme diets. 3.- Pregnancy or intention during study period. 4.- Age <18 years. 5.- Known hypersensitivity to "prazoles" or proton pump inhibitors. 6.- Ingestion of medications that may interfere with PPIs (antifungal and atazanavir). 7.- Previous treatment with proton pump inhibitors, except for a 15 day wash period if the patient's clinical situation allows it

Design outcomes

Primary

Measure	Time frame
Main Objective: Verify the changes in plasmatic PPi and the main molecules that regulate them (ENPP1-3, TNAP) after oral administration of lansoprazole in patients with Pseudoxanthoma Elasticum (PXE).;Secondary Objective: Not applicable;Primary end point(s): Verify the changes in plasmatic PPi and the main molecules that regulate them (ENPP1-3, TNAP) after oral administration of lansoprazole in patients with Pseudoxanthoma Elasticum (PXE).;Timepoint(s) of evaluation of this end point: 8th and 16th week	—

Measure

Time frame

Main Objective: Verify the changes in plasmatic PPi and the main molecules that regulate them (ENPP1-3, TNAP) after oral administration of lansoprazole in patients with Pseudoxanthoma Elasticum (PXE).;Secondary Objective: Not applicable;Primary end point(s): Verify the changes in plasmatic PPi and the main molecules that regulate them (ENPP1-3, TNAP) after oral administration of lansoprazole in patients with Pseudoxanthoma Elasticum (PXE).;Timepoint(s) of evaluation of this end point: 8th and 16th week

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Spain

Contacts

Public ContactGloria Luque

FIMABIS

gloria.luque@gmail.com+34951291977

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026