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A Placebo Controlled Study of MR901 (Talaporfin Sodium Sodium + a Drug-activating Device) for the Relief of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia

NCT02326454 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2018-08-08

No results posted yet for this study

Summary

This study investigates the safety and efficacy of a photosensitive drug (talaporfin sodium) activated by an intraurethrally placed drug-activating device. MR901 is a code used to identify the combination of talaporfin sodium and the drug-activating device. Two different light doses will be tested against placebo groups in this 4-arm study.

Conditions

  • Benign Prostatic Hyperplasia

Interventions

DRUG

talaporfin sodium

1 mg/kg

DRUG

Saline

DEVICE

Drug Activator 100 J/cm

Light Dose: 100 J/cm

DEVICE

Drug Activator 200 J/cm

Light Dose: 200 J/cm

Sponsors & Collaborators

  • Mundipharma Research Limited

    collaborator INDUSTRY

  • Light Sciences Oncology

    lead INDUSTRY

Principal Investigators

  • Lisa Koch-Hulle · LSO

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2017-03-29
Completion
2017-03-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02326454 on ClinicalTrials.gov