Complementary and Alternative Medicine for Urological Symptoms(CAMUS)
NCT ID: NCT00603304
Last Updated: 2012-10-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
369 participants
INTERVENTIONAL
2008-02-29
2010-12-31
Brief Summary
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This kind of scientific study is the best way to find out if the plant extracts really work to prevent men with benign prostatic hyperplasia (BPH) from getting worse. During the study, men will not know which of the two treatments they are assigned to. They will be followed very closely by a study team every 12 weeks to see how they are doing. Men in the CAMUS trial will be studied over 72 weeks. Tests and all medications needed as part of the study will be provided at no charge to the participant. Participants will be responsible for all other costs not associated with the study tests and medications. All information on study participants will be held in the strictest confidence and no one would have access to patient information other than the required authorized health care and research personnel.
Detailed Description
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BPH is a common problem for older men. With BPH, the prostate grows larger. Over time, this growth can cause bothersome urinary symptoms. These symptoms can include frequent and/or urgent urination during the day or at night. Men with BPH can also have a weak urine stream, a stream that stops and starts, a feeling of not emptying the bladder all the way, and/or a need to strain to get urination started. BPH is NOT the same as prostate cancer.
A number of natural products (extracts of different plants) seem to be able to reduce the bothersome symptoms of BPH with very few side effects over a few months. One of the plant extracts comes from the dwarf palm tree (Saw palmetto). The investigators do not know whether these plant extracts will reduce the symptoms of BPH over a longer period of treatment.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Participants will take one 320 mg placebo gelcap daily for 24 weeks one gelcap); followed by 640 mg daily for 24 weeks (two gelcaps) followed by 960 mg daily for 24 weeks (three gelcaps).
Placebo - first 24 weeks
Participants will take one 320 mg chocolate-colored soft gelcaps containing a placebo for 24 weeks.
Placebo - weeks 24 - 48
Participants will take 640 mg (2) chocolate-colored soft gelcaps containing a placebo for 24 weeks.
Placebo - weeks 48 - 72
Participants will take 960 (3) mg chocolate-colored soft gelcaps containing a placebo for 24 weeks.
Saw Palmetto
Extract of Serenoa Repens 320 mg once daily for 24 weeks (one gelcap); followed by 640 mg daily for 24 weeks (two gelcaps) followed by 960 mg daily for 24 weeks (three gelcaps).
Saw Palmetto - first 24 weeks
Participants will take one 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract for 24 weeks.
Saw Palmetto - weeks 24 - 48
Participants will take 640 mg (2) chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract for 24 weeks.
Saw Palmetto - weeks 48 - 72
Participants will take 960 (3) mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract for 24 weeks.
Interventions
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Saw Palmetto - first 24 weeks
Participants will take one 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract for 24 weeks.
Placebo - first 24 weeks
Participants will take one 320 mg chocolate-colored soft gelcaps containing a placebo for 24 weeks.
Saw Palmetto - weeks 24 - 48
Participants will take 640 mg (2) chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract for 24 weeks.
Placebo - weeks 24 - 48
Participants will take 640 mg (2) chocolate-colored soft gelcaps containing a placebo for 24 weeks.
Saw Palmetto - weeks 48 - 72
Participants will take 960 (3) mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract for 24 weeks.
Placebo - weeks 48 - 72
Participants will take 960 (3) mg chocolate-colored soft gelcaps containing a placebo for 24 weeks.
Eligibility Criteria
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Inclusion Criteria
1. Male at least 45 years of age.
2. Peak urinary flow rate at least 4 ml/sec with a voided volume of at least 125 ml.
3. AUA symptom score ≥ 8 and ≤ 24 at both screening visits.
4. Voluntarily signed informed consent agreement prior to the performance of any study procedures.
Exclusion Criteria
2. Phytotherapy for BPH or a 5-alpha reductase inhibitor within 3 months.
3. Alpha blocker within one month.
4. Reported allergic reaction to Serenoa repens.
5. Taken phenylephrine, pseudoephedrine, tricyclic antidepressants, and anticholinergic or cholinergic medication within 4 weeks of the first screening visit, with the following exception: topical anticholinergic eye drops used for glaucoma.
6. Taken an estrogen, androgen, or any drug producing androgen suppression, or anabolic steroids within 6 months.
7. Known clinically significant renal impairment (i.e., creatinine greater than 2.0 mg/dl).
8. Alanine aminotransferase(ALT)serum glutamic pyruvic transaminase(SGPT), aspartate aminotransferase(AST)serum glutamic oxaloacetic transaminase (SGOT) or gamma-glutamyltranspeptidase (GGT) value greater than 3 times the upper limit of normal in the clinical center lab at SV1.0; confirmed on a second measurement.
9. Prothrombin time greater than 3 seconds above the upper limit of normal, or more than 3 seconds above the control value in the clinical center at SV1.0; confirmed on a second measurement.
10. Electrocardiogram (ECG) reading at the clinical center at SV1.0 suggesting active ischemia or recent myocardial infarction until appropriate consultation confirms the absence of an acute coronary syndrome.
11. Prostate-specific antigen (PSA) level greater than 10 ng/ml at the first screening visit.
12. Requires the daily use of a pad or device for incontinence, or International Continence Society male incontinence symptom (ICSmaleIS) score \>14 at screening.
13. Unstable medical condition within the past 3 months.
14. History or current evidence of carcinoma of the prostate or bladder, pelvic radiation or surgery, urethral stricture, or prior surgery for bladder neck obstruction.
15. Active urinary tract disease or has undergone cystoscopy or biopsy of the prostate within one month prior to the first screening visit or has an imminent need for urologic surgery.
16. Known primary neurologic conditions such as multiple sclerosis or Parkinson's disease or other neurological diseases known to affect bladder function.
17. Documented bacterial prostatitis within the past year.
18. Two documented independent urinary tract infections of any type in the past year.
19. Known severe bleeding disorder or need for ongoing therapeutic anticoagulation with coumadin or heparin.
20. Cancer, which is not considered cured (except basal cell or squamous cell carcinoma of the skin). A potential participant is considered cured if there has been no evidence of cancer within five years of randomization. A history of bladder cancer or prostate cancer is exclusionary whether the participant is considered cured or not.
21. Unable to follow protocol directions due to organic brain or psychiatric disease.
22. History of alcoholism or any other substance abuse, which, in the opinion of the investigator, would affect compliance with the protocol.
23. Any serious medical condition likely to impede successful completion of the study.
45 Years
MALE
Yes
Sponsors
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Office of Dietary Supplements (ODS)
NIH
National Center for Complementary and Integrative Health (NCCIH)
NIH
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Cornell University
OTHER
New York University
OTHER
Kaiser Permanente
OTHER
Northwestern University
OTHER
Queen's University
OTHER
University of Colorado, Denver
OTHER
University of Iowa
OTHER
University of Maryland
OTHER
University of Texas
OTHER
Washington University School of Medicine
OTHER
Yale University
OTHER
University of Alabama at Birmingham
OTHER
Responsible Party
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Alan Cantor, PhD
Professor
Principal Investigators
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Michael Barry, MD
Role: STUDY_CHAIR
Massachusetts General Hospital
Alan Cantor, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Alabama at Birmingham
Locations
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Kaiser Permanente Division of Research
Oakland, California, United States
University of Colorado
Aurora, Colorado, United States
Yale University
New Haven, Connecticut, United States
Northwestern University
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
University of Maryland
Baltimore, Maryland, United States
Washington University
St Louis, Missouri, United States
New York University
New York, New York, United States
Cornell University
New York, New York, United States
University of Texas - Southwestern Medical Center
Dallas, Texas, United States
Queen's University
Kingston, Ontario, Canada
Countries
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References
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Lee J, Andriole G, Avins A, Crawford ED, Foster H, Kaplan S, Kreder K, Kusek J, McCullough A, McVary K, Meleth S, Naslund M, Nickel JC, Nyberg L, Roehrborn C, Dale Williams O, Barry M. Redesigning a large-scale clinical trial in response to negative external trial results: the CAMUS study of phytotherapy for benign prostatic hyperplasia. Clin Trials. 2009 Dec;6(6):628-36. doi: 10.1177/1740774509352199. Epub 2009 Dec 9.
Lee JY, Foster HE Jr, McVary KT, Meleth S, Stavris K, Downey J, Kusek JW. Recruitment of participants to a clinical trial of botanical therapy for benign prostatic hyperplasia. J Altern Complement Med. 2011 May;17(5):469-72. doi: 10.1089/acm.2010.0300. Epub 2011 May 9.
Barry MJ, Avins AL, Meleth S; Complementary and Alternative Medicine for Urological Symptoms Study Group. Performance of the American Urological Association Symptom Index with and without an additional urge incontinence item. Urology. 2011 Sep;78(3):550-4. doi: 10.1016/j.urology.2011.04.017. Epub 2011 Jul 8.
Helfand BT, McVary KT, Meleth S, Sharp V, Foster H, Naslund M, Williams OD; CAMUS Study Group. The relationship between lower urinary tract symptom severity and sleep disturbance in the CAMUS trial. J Urol. 2011 Jun;185(6):2223-8. doi: 10.1016/j.juro.2011.02.012. Epub 2011 Apr 17.
Barry MJ, Meleth S, Lee JY, Kreder KJ, Avins AL, Nickel JC, Roehrborn CG, Crawford ED, Foster HE Jr, Kaplan SA, McCullough A, Andriole GL, Naslund MJ, Williams OD, Kusek JW, Meyers CM, Betz JM, Cantor A, McVary KT; Complementary and Alternative Medicine for Urological Symptoms (CAMUS) Study Group. Effect of increasing doses of saw palmetto extract on lower urinary tract symptoms: a randomized trial. JAMA. 2011 Sep 28;306(12):1344-51. doi: 10.1001/jama.2011.1364.
Helfand BT, Lee JY, Sharp V, Foster H, Naslund M, Williams OD, McVary KT; CAMUS Study Group. Associations between improvements in lower urinary tract symptoms and sleep disturbance over time in the CAMUS trial. J Urol. 2012 Dec;188(6):2288-93. doi: 10.1016/j.juro.2012.07.104. Epub 2012 Oct 22.
Other Identifiers
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Tracking # (UAB) 000175609
Identifier Type: OTHER
Identifier Source: secondary_id
X021004002
Identifier Type: -
Identifier Source: org_study_id
NCT00097136
Identifier Type: -
Identifier Source: nct_alias