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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list