NCT00310908

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2006

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 5, 2006

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

February 17, 2009

Status Verified

September 1, 2006

Enrollment Period

2.4 years

First QC Date

April 4, 2006

Last Update Submit

February 15, 2009

Conditions

Renal Calculus

Keywords

RenalColicCalculiTreatment

Outcome Measures

Primary Outcomes (3)

  • Pain improvement according to VAS score at 30, 60 and 120 minutes(Stage I)

    30, 60, 120 minutes

  • Need for rescue medication at 30 minutes (Stage I)

    30 minutes

  • Pain improvement according to VAS score at 24 and 48 hrs (Stage II)

    24 and 48 hrs

Interventions

Tramadol HclDRUG

Active Comparator

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 12000, Israel

Location

Related Publications (1)

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

    PMID: 15208882RESULT

MeSH Terms

Conditions

Kidney CalculiColicCalculi

Interventions

Tramadol

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsDimethylaminesMethylaminesAminesLipids

Study Officials

  • Ruth Stalnikowicz, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 4, 2006

First Posted

April 5, 2006

Study Start

September 1, 2006

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

February 17, 2009

Record last verified: 2006-09

Locations

IL(1)