Clinical Trials Logo
  1. Home
  2. Other
  3. NCT04940741

Efficacy and Safety of VER-01 in the Treatment of Patients With Chronic Non-specific Low Back Pain

Chronic Non-specific Low Back Pain Clinical Trial

Official title:
Proof of Efficacy, Maintenance of Efficacy, Long-term Safety and Investigation of the Potential for Dependence and Abuse and the Effect of Abrupt Drug Withdrawal of VER-01 in the Treatment of Patients With Chronic Non-specific Low Back Pain

Clinical Trial Summary

Analysis of the efficacy, maintenance of efficacy, long-term safety, and investigation of the potential for dependence and abuse and the effect of abrupt drug withdrawal of VER-01 in the treatment of patients with chronic non-specific low back pain when drug treatment is indicated and previous optimised treatments with non-opioid analgesics have not led to sufficient pain relief or were unsuitable due to contraindications or intolerance.

Clinical Trial Description

The study is divided into four phases: Phase A, B, C and D. All patients who have completed Phase A and for whom the investigator considers further participation to be safe shall begin Phase B. Phases C and D run in parallel, so that patients who have completed Phase B and for whom the investigator considers further participation to be safe can be assigned to one of the two phases. Phases A and D follow a double-blind, placebo-controlled design, while Phase B and C have an open-label design. The main goal of Phase A is to demonstrate the efficacy of VER-01 compared to placebo. In Phase B and C the main goal is the investigation of long-term safety of VER-01. In Phase D the primary objective is to demonstrate the maintenance of efficacy of VER-01 on a placebo-controlled basis. The potential for dependence and abuse will be analyzed in all Phases (A,B,C,D), while the effect of abrupt drug withdrawal of VER-01 will be analyzed in Phase C and D. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04940741
Study type Interventional
Source Vertanical GmbH
Contact
Status Completed
Phase Phase 3
Start date July 7, 2021
Completion date March 26, 2024
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05832918 - Effects of Core Stability Exercises and Cognitive Tasks on Chronic Non-specific Back Pain N/A
Completed NCT05915715 - McGill Stabilization Exercises VS Proprioceptive Neuromuscular Facilitation Technique in Chronic Non-specific LBP N/A
Completed NCT00447668 - Effect of Yoga Vs. Stretching on Chronic Back Pain Phase 2
Active, not recruiting NCT05610813 - Comparison of VER-01 to Opioids in Patients With Chronic Non-specific Low Back Pain Phase 3
Not yet recruiting NCT06193603 - Cupping Therapy in Chronic Nonspecific Low Back Pain N/A
Completed NCT06099470 - Investigation of the Effects of Telerehabilitation Groups for Chronic Non-specific Low Back Pain. N/A
Recruiting NCT06071364 - Morphological Changes in Back Muscles With Low Back Pain Patients
Completed NCT03449810 - Effectiveness of Muscles Energy Technique in the Management of Chronic Non-specific Low Back Pain N/A
Completed NCT02387515 - Technology-supported Exercise Therapy for Patients With Chronic Low Back Pain N/A
Recruiting NCT05347368 - Effects of Primal Reflex Release Technique in Chronic Non-specific Low Back Pain N/A
Recruiting NCT02773160 - Motor Learning for the Lumbar Spine Using Sensor-based Postural Feedback: a Randomized Controlled Trial N/A
Recruiting NCT04734314 - Efficacy of Vojta on Balance and Quality of Life in Subject With CNLBP N/A