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RECRUITING
NCT06490445
PHASE2

A Study of Medical Cannabis Aerosol Via the Fixed-dose Syqe Inhaler as an Add-on Treatment of Diabetic Peripheral Neuropathic Pain (DPNP)

Sponsor: Syqe Medical

View on ClinicalTrials.gov

Summary

The primary purpose of this study is to evaluate the efficacy of medical cannabis aerosol containing 0.25, 0.5, 1.0 milligrams (mg) delta (Δ)9-tetrahydrocannabinol (THC) inhaled three times a day (TID) compared to placebo via the Fixed-dose Syqe Inhaler on pain intensity at Week 15.

Official title: A Double-blind, Randomized, Placebo-controlled, 4-arm Parallel-group, Multiple-Dose Study to Assess Efficacy and Safety of Medical Cannabis Aerosol Via the Fixed-dose Syqe Inhaler as an Add-on Treatment of Diabetic Peripheral Neuropathic Pain

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

192

Start Date

2024-11-14

Completion Date

2025-11-08

Last Updated

2025-04-18

Healthy Volunteers

No

Interventions

DRUG

Medical Cannabis

Syqe cartridge containing medical cannabis (Bedrocan®) administered using Fixed-dose Syqe Inhaler.

DRUG

Placebo

Placebo administered using Fixed-dose Syqe Inhaler.

Locations (38)

Innovate Clinical Research

Waitara, New South Wales, Australia

Western Sydney University NICM Health Research Institute (NICM HRI)

Westmead, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Emeritus Research

Camberwell, Victoria, Australia

The Royal Melbourne Hospital

Parkville, Victoria, Australia

Rychnov nad Kneznou, Hradec Kralove

Rychnov nad Kněžnou, Hradec Kralove, Czechia

Ostrava, Ostrava City

Ostrava, Ostrava City, Czechia

Plzen, Plzen City

Pilsen, Plzen City, Czechia

Prague, Praha 12

Prague, Prague, Czechia

Heidelberg, Baden-Wuerttemberg

Heidelberg, Baden-Wurttemberg, Germany

Karlsruhe, Baden-Württemberg

Karlsruhe, Baden-Wurttemberg, Germany

Ulm, Baden-Württemberg

Ulm, Baden-Wurttemberg, Germany

Hamburg, Hamburg

Hamburg, Hamburg, Germany

Hannover, Lower Saxony

Hanover, Lower Saxony, Germany

Schwerin, Mecklenburg

Schwerin, Mecklenburg, Germany

Reinfeld, Schleswig-Holstein

Reinfeld, Schleswig-Holstein, Germany

Berlin, Berlin 4010

Berlin, State of Berlin, Germany

Berlin, Berlin

Berlin, State of Berlin, Germany

Klinische Forschung Dresden GmbH

Dresden, Germany

Klinische Forschung Schwerin GmbH

Schwerin, Germany

The Edith Wolfson Medical Center

Holon, Tel Aviv, Israel

Sheba Medical center Hospital

Ramat Gan, Tel Aviv, Israel

Barzilai Medical center

Ashkelon, Israel

Bnai Zion Medical Center

Haifa, Israel

Rambam Medical Center

Haifa, Israel

Hadassah Medical Center

Jerusalem, Israel

Beilinson hospital/ Petach Tikva

Petah Tikva, Israel

Ziv Medical Center

Safed, Israel

Swidnica, Dolnoslaskie

Swidnica, Lower Silesian Voivodeship, Poland

Sochaczew, Mazowieckie

Sochaczew, Masovian Voivodeship, Poland

Warszawa, Mazowieckie 7011

Warsaw, Masovian Voivodeship, Poland

Warszawa, Mazowieckie

Warsaw, Masovian Voivodeship, Poland

Warszawa, Mazowieckie 7010

Warsaw, Masovian Voivodeship, Poland

Katowice, Silesia

Katowice, Silesian Voivodeship, Poland

Katowice, Śląsk

Katowice, Silesian Voivodeship, Poland

Centrum Medyczne NEUROMED

Bydgoszcz, Poland

Centrum Medyczne Pratia Chojnice

Chojnice, Poland

Osrodek Badan Klinicznych Neuro-Medic Clinic

Katowice, Poland