Comparison Between Tramadol Hcl and Other Analgesics in the Treatment of Renal Colic - Tabular View

Tracking Information

First Received Date ^ICMJE

April 4, 2006

Last Updated Date

February 15, 2009

Start Date ^ICMJE

September 2006

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Pain improvement according to VAS score at 30, 60 and 120 minutes(Stage I) [ Time Frame: 30, 60, 120 minutes ] [ Designated as safety issue: No ]
Need for rescue medication at 30 minutes (Stage I) [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]
Pain improvement according to VAS score at 24 and 48 hrs (Stage II) [ Time Frame: 24 and 48 hrs ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Pain improvement according to VAS score at 30, 60 and 120 minutes(Stage I)
Need for rescue medication at 30 minutes (Stage I)
Pain improvement according to VAS score at 24 and 48 hrs (Stage II)

Change History

Complete list of historical versions of study NCT00310908 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Comparison Between Tramadol Hcl and Other Analgesics in the Treatment of Renal Colic

Official Title ^ICMJE

Efficacy of Tramadol Hcl in the Treatment of Renal Colic

Brief Summary

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.

Detailed Description

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.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Renal Calculus

Intervention ^ICMJE

Drug: Tramadol Hcl

Study Arms / Comparison Groups

Publications *

Ukhal' MI, Melenevskii DA. [Using prostaglandin inhibitor dicloberl in patients with ureteral calculi] Lik Sprava. 2004 Mar;(2):76-8. Russian.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

100

Completion Date

February 2009

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients with clinical diagnosis of acute renal colic (Stage I)
Patients with diagnosed renal colic who might need prevention of pain and are able to swallow medicines (Stage II)

Exclusion Criteria:

Patients with known hypersensitivity to the study drugs
Pregnancy or lactation
Known renal failure or hepatic disease
Concommitant drug use which could adversely affect patient's outcome (oral anticoagulant, MAO inhibitors)

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Israel

Administrative Information

NCT ID ^ICMJE

NCT00310908

Responsible Party

Ruth Stalnikowicz, Hadassah Medical Organization

Study ID Numbers ^ICMJE

1234567-HMO-CTIL

Study Sponsor ^ICMJE

Hadassah Medical Organization

Collaborators ^ICMJE

Grumental

Investigators ^ICMJE

Principal Investigator:

Ruth Stalnikowicz, MD

Hadassah Medical Organization, Jerusalem, Israel

Information Provided By

Hadassah Medical Organization

Verification Date

September 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP