Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00304317
Status:
WITHDRAWN
Last Update Posted:
2017-01-24
First Post:
2006-03-16
Brief Title:
Celecoxib Celebrex in the Management of Acute Renal Colic
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
Celecoxib in the Management of Acute Renal Colic
Status:
WITHDRAWN
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI is no longer at the University of Minnesota
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this trial is to quantify the amount Celebrex a specific cyclooxygenase-2 COX-2 inhibitor when used for the management of acute renal colic for a ureteral stone will
reduce pain medication usage
improve the percentage of spontaneous stone passage
decrease the time to spontaneous passage and
shift the size distribution of stones passed towards larger sizes
reduce pain medication usage
improve the percentage of spontaneous stone passage
decrease the time to spontaneous passage and
shift the size distribution of stones passed towards larger sizes
Detailed Description:
The study will be conducted as a prospective randomized double-blind controlled clinical trial One-hundred and fifty-four patients with symptoms of acute renal colic and a ureteral calculus less than 10 mm in largest diameter on flat plain abdominal x-ray KUB or non-contrast computer tomography CT scan will be randomized in this trial At the time of presentation with acute renal colic to the Emergency Department the patient will be recruited for involvement After informed consent patients will be provided either 200 mg of Celebrex or a placebo equivalent They will be instructed to follow the recommended dosing regimen for acute pain taking two tablets in the emergency room 400 mg followed by one tablet 12 hours later 200 mg then one tablet twice a day for 10 days Patients will be provided a prescription for Vicodin 1-2 tablets of 5500 every 4-6 hours to be taken as required for pain Throughout the study patients will be asked to strain urine for passage of calculus and note date and time of passage Patients will also be asked to maintain a daily narcotic diary and complete a daily pain analog scale provided by our institution Patients will be followed in the Urology Departments Stone Clinic with weekly imaging studies KUB or CT scan and renal function tests serum creatinine for 4 weeks
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 3485B | None | None | None |