- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00448123
The Efficacy of Tamsulosin in the Treatment of Ureteral Stones in Emergency Department Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a prospective randomized placebo controlled study of tamsulosin alone, vs placebo, to determine its effect on the rates of stone passage and resolution of pain in patients with acute renal colic pain that present to the emergency department. The study will be conducted in the Emergency Department (ED)and Emergency Department Observation Unit (EDOU) of William Beaumont Hospital, a high volume, university affiliated 952 bed suburban teaching hospital.
Patients will be given a seven-day supply of tamsulosin (0.4mg daily) or placebo. They will also be given a prescription for Vicodin (30 pills) and Ibuprofen (600mg, 30 pills). They will be called on days 1, 2, 3, 7, and 10 following the index visit regarding passage of stone or 48 hours without pain. Patients will be asked to call in if they pass their stone or are without pain for 48 hours. Related return visits to Royal Oak or Troy Beaumont within 30 days of their index visit will be followed by chart review.
The study will be limited to patients presenting to the emergency department with acutely symptomatic renal colic pain. Confirmation of a symptomatic stone will be made by imaging (helical CT scan or intravenous pyelogram).
Study exclusion criteria:
- Stone not documented on imaging
- Stones >10mm
- Pregnancy
- Age <18 years
- Evidence of infection with an obstructing stone
- Obstructing stone in a solitary kidney
- Currently taking tamsulosin, vardenafil, nifedipine, or steroids
- Contraindications or allergy to tamsulosin
- Ureteral surgery
- Patients that are unable to understand consent
- Patients that are unable to comply with follow-up
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Michigan
-
Royal Oak, Michigan, United States, 48073
- William Beaumont Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Emergency Department patients with acutely symptomatic renal colic pain
- Confirmation of a symptomatic stone will be made by imaging (helical CT scan or intravenous pyelogram).
Exclusion Criteria:
- Stones not documented on imaging
- Stones >10mm
- Pregnancy
- Age <18 years
- Evidence of infection with an obstructing stone
- Obstructing stone in a solitary kidney
- Currently taking tamsulosin, vardenafil, nifedipine, or steroids
- Contraindications or allergy to tamsulosin
- Ureteral surgery
- Patients that are unable to understand consent
- Patients that are unable to comply with follow-up
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Placebo
|
Active Comparator: Tamsulosin
Intervention - Tamsulosin
|
Study Drug
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stone Passage
Time Frame: 1-7 days
|
Participants were asked during the follow-up phone call to indicate if their stone had passed within seven days.
Phone calls were conducted at days 1, 2, 3, 7, 10 and 30 days after the emergency department discharge.
Data is reported based on the information obtained up to the 7th day.
|
1-7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Amount (Mean Number of Tablets Taken) of Pain Medication Taken by Subjects up to Seven (7) Days Post Emergency Department Discharge
Time Frame: 1-7 days
|
1-7 days
|
|
High Pain Score by Treatment Group
Time Frame: 7 Days
|
Severity of Patient Pain at 7 days Post Emergency Department Visit.
Patients were asked to describe their pain severity at each followup phone call, using a numerical scale, ranging from 0 (no pain) to 10 (worst possible pain).
We report this measure at 7 days.
|
7 Days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Swor Robert, DO, William Beaumont Hospitals
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Kidney Diseases
- Urologic Diseases
- Disease Attributes
- Pathological Conditions, Anatomical
- Ureteral Diseases
- Urolithiasis
- Urinary Calculi
- Emergencies
- Calculi
- Kidney Calculi
- Nephrolithiasis
- Ureteral Calculi
- Ureterolithiasis
- Physiological Effects of Drugs
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Urological Agents
- Adrenergic alpha-1 Receptor Antagonists
- Adrenergic alpha-Antagonists
- Tamsulosin
Other Study ID Numbers
- 2005-107
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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