Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2025-12-31 @ 6:57 PM
Study NCT ID:
NCT01995006
Status:
COMPLETED
Last Update Posted:
2015-04-17
First Post:
2013-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Metamizole (Dipyrone) on Renal Function in Salt-depleted Healthy Subjects
Sponsor:
University Hospital, Basel, Switzerland
Organization:
Study Overview
Official Title:
Effect of Metamizole on Renal Function in Salt-depleted Healthy Subjects Single-center, Randomized, Open, Controlled Parallel-group Study to Investigate the Effects of Oral Metamizole or Naproxen on Renal Function in Healthy Male Salt-depleted Subjects
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
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:
None
Brief Summary:
The planned study is a single-center, randomized, open-label parallel group study in 16 healthy male subjects. Study subjects will be randomly allocated either to the metamizole group (1) or to the naproxen group (2). All participants will start with a low sodium diet (approximately 50 mmol Na+ per day) 7 days before the first drug intake and maintain the diet until the end of the study (14 days in total). Salt-depletion is an accepted model to enhance production of vasodilatory prostaglandins and to increase renal sensitivity to prostaglandin inhibition. On the first day of treatment (Day 1), a single dose of metamizole or naproxen will be administered to investigate the effects after a single dose and to collect single dose pharmacokinetic profiles. Starting on Day 2, all participants will receive therapeutic doses, i.e. 1000 mg metamizole 'ter in die' (TID, three times a day) or 500 mg naproxen 'bis in die' (BID, twice a day) for one week and on Day 7 pharmacokinetics and pharmacodynamics effects will be assessed under near steady-state conditions.
The primary objective is the characterization of the renal effects of metamizole by determination of the glomerular filtration rate (GFR) using the inulin clearance. Secondary objectives are the characterization of the urinary excretion of prostaglandin E2 (PGE2) and the prostaglandin I2 (PGI2) metabolite 6-keto-prostaglandin F1 (PGF1)alpha as well as the urinary excretion of sodium and potassium.
Overall, clinical experience suggests better renal tolerability of metamizole possibly due to less potent COX-inhibition compared to classical nonsteroidal antiinflammatory drugs (NSAIDs). If this could be confirmed, metamizole would be a valuable alternative for treatment of painful conditions in patients with impaired renal function. Therefore, the aim of this study is to examine the effects of metamizole on renal function in comparison with the non-specific COX-inhibitor naproxen.
The primary objective is the characterization of the renal effects of metamizole by determination of the glomerular filtration rate (GFR) using the inulin clearance. Secondary objectives are the characterization of the urinary excretion of prostaglandin E2 (PGE2) and the prostaglandin I2 (PGI2) metabolite 6-keto-prostaglandin F1 (PGF1)alpha as well as the urinary excretion of sodium and potassium.
Overall, clinical experience suggests better renal tolerability of metamizole possibly due to less potent COX-inhibition compared to classical nonsteroidal antiinflammatory drugs (NSAIDs). If this could be confirmed, metamizole would be a valuable alternative for treatment of painful conditions in patients with impaired renal function. Therefore, the aim of this study is to examine the effects of metamizole on renal function in comparison with the non-specific COX-inhibitor naproxen.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: