NCT00448123

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
127

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2007

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

February 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 13, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 15, 2007

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
5.1 years until next milestone

Results Posted

Study results publicly available

October 12, 2016

Completed
Last Updated

October 12, 2016

Status Verified

October 1, 2016

Enrollment Period

4.6 years

First QC Date

March 13, 2007

Results QC Date

December 24, 2013

Last Update Submit

October 11, 2016

Conditions

Kidney StonesUreteral Stones

Keywords

Kidney StonesUreteral StonesFlomaxEmergency MedicineUrology

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Amount (Mean Number of Tablets Taken) of Pain Medication Taken by Subjects up to Seven (7) Days Post Emergency Department Discharge

    1-7 days

  • High Pain Score by Treatment Group

    7 Days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Tamsulosin

ACTIVE COMPARATOR

Intervention - Tamsulosin

Drug: Tamsulosin

Interventions

TamsulosinDRUG

Study Drug

Also known as: Flomax
Tamsulosin
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

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

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Related 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.

    PMID: 26429522RESULT

MeSH Terms

Conditions

Kidney Calculi

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur Compounds

Limitations and Caveats

Limitations of this study include non-consecutive enrollment and small sample size.

Results Point of Contact

Title
Robert Swor, DO
Organization
William Beaumont Hospital
raswor@beaumont.edu
248-89-81970

Study Officials

  • Swor Robert, DO

    Corewell Health East

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 13, 2007

First Posted

March 15, 2007

Study Start

February 1, 2007

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

October 12, 2016

Results First Posted

October 12, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)