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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00448123
Other study ID # 2005-107
Secondary ID
Status Completed
Phase N/A
First received March 13, 2007
Last updated October 11, 2016
Start date February 2007
Est. completion date September 2011

Study information

Verified date October 2016
Source William Beaumont Hospitals
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

To determine if emergency department patients with acute ureteral colic pain due to a ureteral stone who are treated with tamsulosin, versus placebo, will experience a shorter time to passage of their stone or resolution of their pain. A secondary study objective will be to determine if there is a relationship between response to tamsulosin and stone size or position in the ureter.


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


Recruitment information / eligibility

Status Completed
Enrollment 127
Est. completion date September 2011
Est. primary completion date September 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Intervention

Drug:
Tamsulosin
Study Drug
Placebo
Placebo

Locations

Country Name City State
United States William Beaumont Hospital Royal Oak Michigan

Sponsors (2)

Lead Sponsor Collaborator
Robert Swor William Beaumont Hospitals

Country where clinical trial is conducted

United States, 

References & Publications (1)

Berger DA, Ross MA, Hollander JB, Ziadeh J, Chen C, Jackson RE, Swor RA. Tamsulosin does not increase 1-week passage rate of ureteral stones in ED patients. Am J Emerg Med. 2015 Dec;33(12):1721-4. doi: 10.1016/j.ajem.2015.08.006. Epub 2015 Aug 7. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Stone Passage 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 No
Secondary Amount (Mean Number of Tablets Taken) of Pain Medication Taken by Subjects up to Seven (7) Days Post Emergency Department Discharge 1-7 days No
Secondary High Pain Score by Treatment Group 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 No
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