|
ISRCTN
|
ISRCTN85291415
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
A multicentre, randomised clinical trial to evaluate the efficacy of oral ciprofloxacin, oral tamsulosin, and the combination of oral ciprofloxacin and oral tamsulosin for the treatment of Chronic Prostatitis/Chronic Pelvic Pain Syndrome
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N/A
|
|
Study hypothesis
|
Not provided at time of registration
|
|
Lay summary
|
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Multicentre randomised double blind placebo controlled 2x2 factorial trial
|
|
Countries of recruitment
|
United States of America
|
|
Disease/condition/study domain
|
Chronic Prostatitis (CP)/Chronic Pelvic Pain Syndrome (CPPS)
|
|
Participants - inclusion criteria
|
Approximately 184 participants, 46 per arm, were treated and followed for a total of 12 weeks. These participants were male, had symptoms of discomfort or pain in the pelvic region for at least a 3 month period within the last 6 months, and had a overall score of equal to or greater than 15 out of 43 points on the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score.
|
|
Participants - exclusion criteria
|
Does not match inclusion criteria
|
|
Anticipated start date
|
01/07/2001
|
|
Anticipated end date
|
30/09/2002
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
184 (196 final [added 25/08/09])
|
|
Interventions
|
A 2x2 factorial design assessing four interventions: ciprofloxacin alone, tamsulosin alone, the combination of ciprofloxacin and tamsulosin, and placebo. All treatments were provided for six weeks.
Please note that as of 25/08/09 the start and end dates of this trial have been updated. The initial dates, 01/04/2002 to 30/04/2004, were generated at the time of registration.
|
|
Primary outcome measure(s)
|
Not provided at time of registration
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
1. National Institutes of Health (NIH) (USA) - cooperative agreements U01 DK53572, U01 DK53730, U01 DK53736, U01 DK53734, U01 DK53732, U01 DK53746, and U01 DK53738.
2. Boehringer Ingelheim (USA) - provided tamsulosin and matching placebo
3. Bayer Corporation (USA) - provided ciprofloxacin and matching placebo.
|
|
Trial website
|
|
|
Publications
|
2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15492337
|
|
Contact name
|
Dr
Kathleen
Propert
|
|
Address
|
University of Pennsylvania School of Medicine
Blockley Hall 6th Floor
423 Guardian Drive
|
|
City/town
|
Philadelphia, PA
|
|
Zip/Postcode
|
19104-6021
|
|
Country
|
United States of America
|
|
Sponsor
|
National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health (NIDDK, NIH) (USA)
|
|
Address
|
Dr John W. Kusek
2 Democracy Plaza
Room 617
6707 Democracy Boulevard
|
|
City/town
|
Bethesda, MD
|
|
Zip/Postcode
|
20892-5458
|
|
Country
|
United States of America
|
|
Sponsor website:
|
http://www.niddk.nih.gov
|
|
Date applied
|
30/06/2004
|
|
Last edited
|
25/08/2009
|
|
Date ISRCTN assigned
|
11/11/2004
|
