Condition category
Urological and Genital Diseases
Date applied
30/06/2004
Date assigned
11/11/2004
Last edited
25/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Kathleen Propert

ORCID ID

Contact details

University of Pennsylvania School of Medicine
Blockley Hall 6th Floor
423 Guardian Drive
Philadelphia
PA
19104-6021
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

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

Trial setting

Hospitals

Trial 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

Phase

Not Specified

Drug names

Ciprofloxacin, tamsulosin

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/07/2001

Overall trial end date

30/09/2002

Reason abandoned

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

Patient

Age group

Adult

Gender

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

Trial 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

http://www.niddk.nih.gov

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15492337

Publication citations

  1. Results

    Alexander RB, Propert KJ, Schaeffer AJ, Landis JR, Nickel JC, O'Leary MP, Pontari MA, McNaughton-Collins M, Shoskes DA, Comiter CV, Datta NS, Fowler JE, Nadler RB, Zeitlin SI, Knauss JS, Wang Y, Kusek JW, Nyberg LM, Litwin MS, , Ciprofloxacin or tamsulosin in men with chronic prostatitis/chronic pelvic pain syndrome: a randomized, double-blind trial., Ann. Intern. Med., 2004, 141, 8, 581-589.

Additional files

Editorial Notes