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

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

Drug Information available for: Tramadol Tramadol hydrochloride

U.S. FDA Resources

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

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:

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 ]

Estimated Enrollment:	100
Study Start Date:	September 2006
Study Completion Date:	February 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Active Comparator

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00310908

Locations

Israel
Hadassah Medical Organization
Jerusalem, Israel, 12000

Sponsors and Collaborators

Hadassah Medical Organization

Grumental

Investigators

Principal Investigator:

Ruth Stalnikowicz, MD

Hadassah Medical Organization, Jerusalem, Israel

More Information

Publications:

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

Responsible Party:	Hadassah Medical Organization ( Ruth Stalnikowicz )
Study ID Numbers:	1234567-HMO-CTIL
Study First Received:	April 4, 2006
Last Updated:	February 15, 2009
ClinicalTrials.gov Identifier:	NCT00310908 History of Changes
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:

Renal
Colic
Calculi
Treatment

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Urinary Calculi
Tramadol
Urolithiasis
Colic
Central Nervous System Depressants
Narcotics
Calculi

Urologic Diseases
Kidney Diseases
Analgesics
Peripheral Nervous System Agents
Nephrolithiasis
Kidney Calculi
Analgesics, Opioid

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Urinary Calculi
Tramadol
Urolithiasis
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Calculi
Pharmacologic Actions
Urologic Diseases

Sensory System Agents
Therapeutic Uses
Kidney Diseases
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Nephrolithiasis
Kidney Calculi
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 07, 2009