SPECIAL NOTICE
A -- UTILIZATION OF A FIXED DOSE ALPHA-BLOCKER BPH MEDICATION AS AN ACTIVE COMPARATOR IN A CLINICAL TRIAL OF PHYTOTHERAPY FOR THE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA
- Notice Date
- 3/10/2003
- Notice Type
- Special Notice
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Nat'l Institute of Diabetes, Digestive, & Kidney Diseases, 2 Democracy Plaza, Suite 700W 6707 Democracy Blvd., MSC 5455, Bethesda, MD, 20892-5455
- ZIP Code
- 20892-5455
- Solicitation Number
- DK-02-0115
- Archive Date
- 5/15/2003
- Point of Contact
- Rochelle Blaustein J.D., Director, Technology Transfer and Development, Phone 301-451-3636, Fax 301-401-7461, - Linda Schilling, Technology Development Specialist, Phone 301-451-3638, Fax 301-402-7461,
- E-Mail Address
-
rochelleb@intra.niddk.nih.gov, lindas@intra.niddk.nih.gov
- Description
- This is a request for a Collaborator to provide a fixed daily dose alpha-blocker BPH medication to be used as an active comparator for one arm of a four-arm double-blinded multicenter clinical trial that is designed to compare the long term effects of two phytotherapeutic agents: saw palmetto and pygeum africanum, vs. placebo, on the progression of symptomatic benign prostatic hyperplasia. INTRODUCTION: The NIDDK is developing a double-blinded multicenter placebo controlled clinical trial to evaluate the long-term effects of two phytotherapeutic agents: saw palmetto and pygeum africanum on BPH progression as compared to placebo. A fourth treatment arm of the trial will utilize a single dose BPH specific alpha-blocker as an active comparator to ensure treatment validity of the participant population. The four-arm trial will enroll approximately 3,000 participants who will be randomized to receive either saw palmetto, pygeum africanum, an alpha-blocker, or placebo. Participants and investigators will be blinded to all treatment agents. Each agent will have a comparable placebo pill. Enrollment will occur at eleven participating clinical centers. Central data collection and analysis will occur at the NIDDK funded Data Coordinating Center at the University of Alabama, Birmingham. STUDY GOAL: The overall goal of this study is to determine whether either of two commonly used phytotherapy agents have an effect on the progression of the symptoms of BPH over a five year trial period. The alpha-blocker medication will be used to demonstrate that the cohort of men enrolled in the trial have symptomatic BPH which responds to a known effective therapy.. Each treatment arm will be compared to placebo. The trial will not be powered for head-to-head comparisons of each treatment arm. SUPPLEMENTAL INFORMATION: There are no published long-term, placebo-controlled trials of the two phytotherapeutic agents for the treatment of the progression of symptomatic BPH. This will be the first long-term trial using these two agents, with an active comparator. The duration of the trial will be five years. The Collaborator providing the alpha-blocker will be expected to provide free active drug and for the duration of the study for approximately 750 enrolled participants, and will be expected to provide free matching placebo for the duration of the study for approximately 2250 participants. The Collaborator will have input into the development of the clinical trial protocol, and will participate in the trial as an ex-officio member of the Steering and Planning Committee, having the same access to trial progress data as the other members of the Steering and Planning Committee. The Collaborator may have access to unblinded data at the completion of the trial at the same time as the participating investigators. The Collaborator may participate as a member of the publication committee. The NIDDK Project Scientist will obtain any IND?s required for the trial. The Collaborator will provide NIDDK staff with information and data necessary to meet the FDA IND requirements. CAPABILITY STATEMENTS: A Selection Committee will utilize the information provided in the ?Collaborator Capability Statements? to help in their deliberations. It is the intention of the NIDDK that qualified applicants will have the opportunity to provide information to the Selection Committee through their Capability Statements. The Capability Statement may not exceed 10 pages and should address the following criteria: Details on FDA drug approval status; Time line for ability to provide drug and placebo after selection of Collaborator is determined; Approved daily dose of drug; Previous studies of efficacy of drug in treating symptomatic BPH; Known side-effects of drug; Known interactions with other drugs, herbal agents, etc. SUBMISSION DATES: A written statement of interest must be submitted by 1 April 2003 and all Collaborator Capability Statements must be submitted by 1 May 2003 CONTACT INFORMATION: Submit statements of interest and Capability Statements to: Rochelle S. Blaustein, J.D., Office of Technology Transfer and Development National Institute of Diabetes and Digestive and Kidney Diseases, 12 South Drive, Room 3011, MSC 5632, Bethesda, MD 20892-5632. For Scientific Inquiries contact John W. Kusek, Ph.D., Director, Clinical Trials, DKUHD/NIDDK, 6707 Democracy Blvd., Room 617, Bethesda, MD 20892-5458, KusekJ@extra.niddk.nih.gov or Leroy M. Nyberg, Jr., Ph.D., M.D, Director, Urology Programs, DKUHD/NIDDK, 6707 Democracy Blvd., Room 627, Bethesda, MD 20892-5458, NybergL@extra.niddk.nih.gov, Tel: 301-594-7717, FAX: 301-480-3510
- Record
- SN00275497-W 20030312/030310213338 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
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