EUCTR2016-002656-24-GB
Active, not recruiting
Phase 1
A randomised placebo-controlled clinical trial of fenofibrate to prevent progression of non-proliferative retinopathy in diabetes - LENS version 1.0
niversity of Oxford (Clinical Trials and Research Governance))0 sites1,060 target enrollmentMay 23, 2018
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity of Oxford (Clinical Trials and Research Governance))
- Enrollment
- 1060
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •i) Subjects capable of giving informed consent
- •ii) Diabetes Mellitus (any type except gestational diabetes)
- •iii) Age 18 years or above
- •iv) Observable diabetic retinopathy (defined in the Scottish national retinopathy grading scheme as R2 and/or M1 in one/both eyes, or R1 in both eyes) at the patient's most recent retinal screening visit
- •v) Willing to either complete electronic questionnaires or conduct telephone interviews for collection of questionnaire data once every 6 months
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 600
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •i) Clinically significant DR (defined as R3 or R4 or M2 in one or both eyes)
- •ii) History of gallbladder disease (cholecystitis, symptomatic gallstones, cholecystectomy)
- •iii) History of acute or chronic pancreatitis
- •iv) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2X the upper limit of normal (ULN) according to local NHS laboratory reference range
- •v) Creatine kinase (CK) \>3X ULN according to local NHS laboratory reference range
- •vi) Estimated glomerular filtration rate (eGFR) \<40mL/min/m2 at screening
- •vii) Cirrhosis of any aetiology or any other serious hepatic disease (investigator opinion)
- •viii) Female who is pregnant, breastfeeding, currently trying to become pregnant, or of child\-bearing potential and not practicing birth control
- •ix) Ongoing warfarin, cyclosporine, vitamin K antagonist (warfarin, phenindione, acenocoumarol), colchicine, ketoprofen, daptomycin or fibrate therapy
- •x) Previous myositis or rhabdomyolysis of any cause, or diagnosed hereditary muscle disorder
Outcomes
Primary Outcomes
Not specified
Similar Trials
Not yet recruiting
Phase 3
SLeep Evaluation and Effectiveness Protocol for Intensive Care Units (SLEEP-ICU)ACTRN12624000991516South Metropolitan Health Service72
Completed
Not Applicable
The Efficacy of Caralluma for Anxiety in AdultsAnxietyStressMental Health - AnxietyAlternative and Complementary Medicine - Herbal remediesACTRN12616000741482RDC Global117
Active, not recruiting
Not Applicable
A randomized placebo-controlled clinical trial of topical photodynamic therapy with a nanoemulsion formulation of 5-aminolevulinic acid for the treatment of actinic keratosisEUCTR2006-000314-20-DEBiofrontera Bioscience GmbH260
Completed
Not Applicable
A randomized placebo controlled clinical trial of a rehabilitation programme for patients with a diagnosis of massive, irreparable rotator cuff tears of the shoulderISRCTN64734872Record Provided by the NHSTCT Register - 2006 Update - Department of Health60
Not yet recruiting
Phase 3
A placebo-controlled, randomized clinical trial of vigabatrin in the management of acute alcohol withdrawalalcohol withdrawalMental Health - AddictionACTRN12607000362493Professor Jon Currie120