Clinical Evaluation of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) NX02-0018

Phase 3

Completed

• Conditions: Benign Prostatic Hyperplasia (BPH)
• Interventions: Drug: Placebo; Drug: NX-1207

• Registration Number: NCT00945490
• Lead Sponsor: Nymox Corporation

Brief Summary

This study will evaluate the safety and efficacy of a 2.5 mg dose of NX-1207 for the treatment of BPH (benign prostatic hyperplasia) as compared to placebo.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-07-22
• Study First Submitted QC: 2009-07-22
• Study First Posted: 2009-07-24
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2017-03
• Disposition First Submitted: 2017-03-09
• Disposition First Submitted QC: 2017-03-09
• Last Update Submitted: 2017-03-09
• Disposition First Posted: 2017-03-10
• Last Update Posted: 2017-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 500

Inclusion Criteria

1. Provide signed informed consent prior to enrolment in the study
2. AUASI ≥ 15
3. Prostate Volume ≥ 30 mL ≤ 70 mL
4. Qmax < 15 mL/sec based on a minimum void of 125 mL
5. Agree not to use any other approved or experimental BPH or OAB medication anytime during the study

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Exclusion Criteria

1. History of illness or condition that may interfere with study or endanger subject
2. Use of prescribed medications that may interfere with study or endanger subject
3. Presence of a median lobe of the prostate
4. Previous surgery or MIST for treatment of BPH
5. Post-void residual urine volume > 200 mL
6. PSA ≥ 10 ng/mL; prostate cancer must be ruled out (negative biopsy) for PSA ≥ 4 ng/mL
7. Participation in a study of any investigational drug or device within the previous 90 days
8. Prostate cancer

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
NX-1207	NX-1207	-

Primary Outcome Measures

Name	Time	Method
American Urological Association Symptom Index (AUASI)	365 days

Secondary Outcome Measures

Name	Time	Method
American Urological Association Symptom Index (AUASI)	270 days
Peak urine flow rate (Qmax)	180 days

Trial Locations

Locations (2)

For information concerning this clinical site, please contact Nymox at 800-936-9669.; 🇺🇸 Richmond, Virginia, United States

For information concerning this clinical site, please contact Nymox at 800-936-9669; 🇺🇸 Grand Rapids, Michigan, United States