Condition category
Urological and Genital Diseases
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
28/03/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Kim Davenport

ORCID ID

Contact details

Urology Department
North Bristol NHS Trust
Southmead Hospital
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom
DrKimDav@aol.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0234135766

Study information

Scientific title

Acronym

Study hypothesis

Can tamsulosin, an alpha-1-adrenergic antagonist, be used in uncomplicated renal colic to improve spontaneous ureteric calculus passage rates.

Ethics approval

1. Approval for the lead centre: Central and South Bristol Research Ethics Committee. Date of approval: 24/09/2004 (ref: 04/Q2006/88). All other centres obtained approval before recruitment of participants.
2. Medicines and Healthcare products Regulatory Agency (MHRA). Approval expected in May 2008.

Study design

Randomised, double-blind, placebo-controlled, multi-centre trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Urological and Genital Diseases: Acute renal colic

Intervention

As of 28/03/2013 the trial status was changed to 'stopped' as the trial was closed in January 2011 due to recruitment issues.

Please note that, as of 11/04/2008, the anticipated start and end dates of this trial were updated from 01/06/2005 and 01/04/2007 to 01/05/2008 and 31/05/2010.

This study is proposed to be a prospective, randomised double blind placebo controlled clinical trial. The patients will be randomly allocated to receive tamsulosin or placebo for a maximum of 6 weeks during conservative treatment of renal colic. Patients will be regularly monitored for side effects, stone passage and analgesic use during this time period.

Intervention type

Drug

Phase

Not Specified

Drug names

Tamsulosin

Primary outcome measures

Primary outcome measures amended as of 11/04/2008:
1. Spontaneous stone passage within 6 weeks
2. Early intervention due to complications

Primary outcome measures provided at time of registration:
1. The percentage of calculi passed spontaneously within 6 weeks
2. The mean time to spontaneous passage
3. The mean use of analgesia in the form of diclofenac (recommended first line analgesic)

Secondary outcome measures

Added as of 11/04/2008:
The following will be assessed at the end of the trial, i.e. time of stone passage or 6 weeks if stone not passed:
1. Percentage of calculi passed spontaneously within six weeks
2. Mean time to spontaneous passage
3. Mean use of analgesia in the form of diclofenac

Overall trial start date

01/05/2008

Overall trial end date

31/05/2010

Reason abandoned

Participant recruitment issue

Eligibility

Participant inclusion criteria

The total sample size required to produce statistically significant results is 206 patients (103 to receive placebo). All patients with renal colic with a visible calculus on X-ray which has been confirmed to be present within the ureter on intravenous urogram (IVU) will be asked to participate.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

206

Participant exclusion criteria

Patients will be excluded if pregnant, symptoms present for >14 days, evidence of infection or if they are already receiving treatment with tamsulosin or other calcium channel blocker.

Recruitment start date

01/05/2008

Recruitment end date

31/05/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Urology Department
Bristol
BS10 5NB
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

North Bristol NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes