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

This study is currently recruiting participants.
Verified by Hadassah Medical Organization, March 2006

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   

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
Estimated Study Completion Date:   December 2008
Estimated Primary Completion Date:   March 2007 (Final data collection date for primary outcome measure)

Intervention Details:
    Drug: Tramadol Hcl
    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

Contacts
Contact: Ruth Stalnikowicz, MD     00 972-2-5844366     darvasi@md.huji.ac.il    
Contact: Shaden Salamae, MD     00972-2-5844366     shaden@hadassah.org.il    

Locations
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            

Sponsors and Collaborators
Hadassah Medical Organization
Grumental

Investigators
Principal Investigator:     Ruth Stalnikowicz, MD     Hadassah Medical Organization, Jerusalem, Israel    
  More Information

Publications of Results:

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

Keywords provided by Hadassah Medical Organization:
Renal  
Colic  
Calculi  
Treatment  

Study placed in the following topic categories:
Pathological Conditions, Anatomical
Urinary Calculi
Urologic Diseases
Tramadol
Urolithiasis
Colic
Kidney Diseases
Calculi
Nephrolithiasis
Kidney Calculi

Additional relevant MeSH terms:
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions
Analgesics, Opioid

ClinicalTrials.gov processed this record on September 05, 2008




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