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NCT02326454
A Phase 2 Randomised, Double-blind, Placebo Controlled, Study of MR901 in Patients With Moderate to Severe Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)
Phase 2 trial testing talaporfin sodium in Benign Prostatic Hyperplasia in 225 participants. Completed in 29 March 2017.
29 March 2017
Quick facts
| Lead sponsor | Light Sciences Oncology |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 225 |
| Start date | 1 November 2014 |
| Primary completion | 29 March 2017 |
| Estimated completion | 29 March 2017 |
| Sites | 41 locations across United States |
Drugs / interventions tested
- talaporfin sodium — full drug profile →
- Saline
- Drug Activator 100 J/cm
- Drug Activator 200 J/cm
Conditions studied
- Benign Prostatic Hyperplasia — all drugs for Benign Prostatic Hyperplasia →
Sponsor
Light Sciences Oncology — full company profile →
Who can join
40 and older, male only, with Benign Prostatic Hyperplasia. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
International Prostate Symptoms Score (IPSS) Questionnaire
Time frame: 12 weeks
Change from baseline in the total International Prostate Symptom Score (IPSS, Questions 1-7)
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02326454
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Benign Prostatic Hyperplasia
Currently open trials in the same condition.
- NCT07444385 — A Study to Evaluate the Safety and Pharmacokinetics of AD-116 and AD-1161 in Healthy Adult Male Subjects · Phase 1 · recruiting
- NCT07293442 — Pelvic Floor Muscle Exercise for Lower Urinary Tract Symptoms After Surgery for Benign Prostatic Hyperplasia. · NA · recruiting
- NCT06657872 — Local Anesthesia With Schelin Catheter in Rezum Treatment: a Randomized Controlled Trial · NA · recruiting
- NCT06852859 — Patient-reported Pain and Symptom Relief During Three Months After Surgery for Benign Prostatic Hyperplasia · recruiting
- NCT06849258 — A Clinical Study to Evaluate the Safety and Efficacy of the FloStent in Men With Benign Prostatic Hyperplasia Symptoms · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02326454 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Light Sciences Oncology
- Last refreshed: 6 August 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02326454.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing