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| Sponsors and Collaborators: |
Hadassah Medical Organization Grumental |
| Information provided by: | Hadassah Medical Organization |
| ClinicalTrials.gov Identifier: | NCT00310908 |
Purpose
The purpose of this study is to determine whether Tramadol Hcl is as effective as Voltaren a non-steroidal antiinflammatory drug, and Dipyrone in amelioration of the pain caused by acute renal colic.
| Condition | Intervention | Phase |
|
Renal Calculus |
Drug: Tramadol Hcl |
Phase IV |
| ChemIDplus related topics: | Tramadol hydrochloride Tramadol |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
| Official Title: | Efficacy of Tramadol Hcl in the Treatment of Renal Colic |
| Estimated Enrollment: | 100 |
| Study Start Date: | September 2006 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
Renal stones is a common condition affecting up to 1% of the american population. The main symptom is renal colic. Acute treatment is based on the administration of analgesics mainly those belonging to non-steroidal antiinflammatory drugs (NSAIDs). Tramadol is an analgesic of the opioid class of analgesics (i.e morphine) and it is considered to cause less side effects with more or less the same analgesic potency. In the present study the analgesic effect of intramuscular Tramadol will be compared with Voltaren (NSAID)in patients attending the Emergency Department (ED) for acute renal colic (Stage I). Most of these patients will not pass their stone during their visit to the ED and they are prone to develop another attack of renal colic.In the second phase of the study (Stage II)patients who improved, and are ready to go home, will be enrolled to get Dipyrone or Tramadol orally for the prevention of further pain.
Eligibility
| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Ruth Stalnikowicz, MD | 00 972-2-5844366 | darvasi@md.huji.ac.il |
| Contact: Shaden Salamae, MD | 00972-2-5844366 | shaden@hadassah.org.il |
| Israel | |||||
| Hadassah Medical Organization | Recruiting | ||||
| Jerusalem, Israel, 12000 | |||||
| Contact: Arik Tzukert, DMD 00972 2 6776095 arik@hadassah.org.il | |||||
| Contact: Hadas Lemberg, Phd 00 972 26777572 lhadas@hadassah.org.il | |||||
| Principal Investigator: Ruth Stalnikowicz, MD | |||||
| Hadassah Medical Organization |
| Grumental |
| Principal Investigator: | Ruth Stalnikowicz, MD | Hadassah Medical Organization, Jerusalem, Israel |
More Information
| Responsible Party: | Hadassah Medical Organization ( Ruth Stalnikowicz ) |
| Study ID Numbers: | 1234567-HMO-CTIL |
| First Received: | April 4, 2006 |
| Last Updated: | July 8, 2008 |
| ClinicalTrials.gov Identifier: | NCT00310908 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
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