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

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ClinicalTrials.gov Identifier: NCT00310908
Recruitment Status : Completed
First Posted : April 5, 2006
Last Update Posted : February 17, 2009
Sponsor:
Collaborator:
Grumental
Information provided by:
Hadassah Medical Organization

Study Description
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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.

Condition or disease Intervention/treatment Phase
Renal Calculus Drug: Tramadol Hcl Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Tramadol Hcl in the Treatment of Renal Colic
Study Start Date : September 2006
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

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Arms and Interventions
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Intervention Details:
  • Drug: Tramadol Hcl
    Active Comparator

Outcome Measures
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Primary Outcome Measures :
  1. Pain improvement according to VAS score at 30, 60 and 120 minutes(Stage I) [ Time Frame: 30, 60, 120 minutes ]
  2. Need for rescue medication at 30 minutes (Stage I) [ Time Frame: 30 minutes ]
  3. Pain improvement according to VAS score at 24 and 48 hrs (Stage II) [ Time Frame: 24 and 48 hrs ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00310908


Locations
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Israel
Hadassah Medical Organization
Jerusalem, Israel, 12000
Sponsors and Collaborators
Hadassah Medical Organization
Grumental
Investigators
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Principal Investigator: Ruth Stalnikowicz, MD Hadassah Medical Organization
More Information
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Publications of Results:

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Responsible Party: Ruth Stalnikowicz, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00310908    
Other Study ID Numbers: 1234567-HMO-CTIL
First Posted: April 5, 2006    Key Record Dates
Last Update Posted: February 17, 2009
Last Verified: September 2006
Keywords provided by Hadassah Medical Organization:
Renal
Colic
Calculi
Treatment
Additional relevant MeSH terms:
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Kidney Calculi
Nephrolithiasis
Calculi
Renal Colic
Pathological Conditions, Anatomical
Pain
Neurologic Manifestations
Kidney Diseases
Urologic Diseases
Urolithiasis
 Urinary Calculi
Tramadol
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents