Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval(s)
Not provided at time of registration
Study design
Multicentre randomised double blind placebo controlled 2x2 factorial trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Condition
Chronic Prostatitis (CP)/Chronic Pelvic Pain Syndrome (CPPS)
Intervention
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.
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
Ciprofloxacin, tamsulosin
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall study start date
01/07/2001
Overall study end date
30/09/2002
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Male
Target number of participants
184 (196 final [added 25/08/09])
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/07/2001
Recruitment end date
30/09/2002
Locations
Countries of recruitment
United States of America
Study participating centre
University of Pennsylvania School of Medicine
Philadelphia, PA
19104-6021
United States of America
Sponsor information
Organisation
National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health (NIDDK, NIH) (USA)
Sponsor details
Dr John W. Kusek
2 Democracy Plaza
Room 617
6707 Democracy Boulevard
Bethesda
MD
20892-5458
United States of America
Sponsor type
Research organisation
Website
ROR
Funders
Funder type
Government
Funder name
National Institutes of Health (NIH) (USA) - cooperative agreements U01 DK53572, U01 DK53730, U01 DK53736, U01 DK53734, U01 DK53732, U01 DK53746, and U01 DK53738.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Boehringer Ingelheim (USA) - provided tamsulosin and matching placebo
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Bayer Corporation (USA) - provided ciprofloxacin and matching placebo.
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 19/10/2004 | Yes | No |