NL-OMON54216
Recruiting
Phase 3
A placebo-controlled, double-blind randomized trial evaluating the effect of etidronate in young patients with pseudoxanthoma elasticum on ectopic mineralization. - TEMP-PREVENT
niversitair Medisch Centrum Utrecht0 sites76 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Grönblad-Strandberg syndrome
- Sponsor
- niversitair Medisch Centrum Utrecht
- Enrollment
- 76
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •In order to be eligible to participate in this study, a subject must meet all
- •of the following criteria:
- •\- Be between 18 years and 55 years.
- •\- Have a definitive diagnosis of PXE according to the Plomp criteria, which
- •confirm a diagnosis of PXE when at least two (or more) criteria not belonging
- •to the same category (skin, eye, genetic) are met:
- •a. Yellowish papules and/or plaques on the lateral side of the neck and/or
- •flexural areas of the body or
- •b. Increase of morphologically altered elastin with fragmentation, clumping and
- •calcification of elastic fibers in a skin biopsy taken.
Exclusion Criteria
- •A potential subject who meets any of the following criteria will be excluded
- •from participation in this study:
- •1\. Patients that are unable or unwilling to sign for informed consent.
- •2\. Pregnant, lactating, or fertile women who might wish to become pregnant
- •within three years.
- •3\. Patients with an estimated glomerular filtration rate below 30 ml/min/1\.73m2
- •according to the CKD\-EPI equation.
- •4\. Patients with a known abnormality of the oesophagus that would interfere
- •with passage of the drug (e.g. oesophagus stenosis).
- •5\. Patients with chronic diarrhoea (\> 1 month).
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 3
TEMP-PREVENT2024-512133-33-00Universitair Medisch Centrum Utrecht76
Not yet recruiting
Phase 4
A randomized, double-blind placebo-controlled trial for Zishen Yutai Pill for endometrial repair in patients after artificial abortioITMCTR2000003334Centre for Reproductive Medicine, Tongji Medical College, Huazhong University of Science and Technology
Completed
Not Applicable
A randomized double blind, placebo-controlled trial of efficacy and safety of Kamishoyosan in patients with climacteric symptomsClimacteric symptomsJPRN-UMIN000005079Hirosaki University Graduate School of Medicine200
Active, not recruiting
Phase 1
A study to look at the changes in the fatty deposits in the walls of the blood vessels of your heart and blood levels of your good” and bad” cholesterol and safety when MDCO-216 is taken in patients with a recent heart problem caused by a decreased blood flow to the heart.EUCTR2015-000826-13-HUThe Medicines Company120
Active, not recruiting
Phase 1
A study to look at the changes in the fatty deposits in the walls of the blood vessels of your heart and blood levels of your good” and bad” cholesterol and safety when MDCO-216 is taken in patients with a recent heart problem caused by a decreased blood flow to the heart.EUCTR2015-000826-13-NLThe Medicines Company120