Intervertebral DXM Gel Injection in Adults With Painful Lumbar Degenerative Disc Disease
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Chronic Lower Back Pain
- Degenerative Disc Disease
- Discogenic Pain
- Intervertebral Disc Degeneration
- Lumbar Disc Degeneration
- Lumbar Disc Disease
- Lumbar Disc Pain
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: This is an adaptative-design, interventional, open-label, single-arm trial performed at a single centre in France. 3 cohorts will be sequentially initiated according to the DSMB review of the safety parameters : The safety primary endpoints of each cohort will be assessed by an independent Data Safety Monitoring Board (DSMB) at Day 42 post-injection to provide safety oversight on the patients and guidance on initiating the study on the next cohort. Patients will be injected at day 0 and will be followed-up for a variable period according to the cohort. As the first enrolled cohort, the 1L cohort will have the longest follow-up (48 weeks) and will attend 9 visits. The second cohort (2L) will have a shorter follow-up period (36 weeks) attend the same visits except for V9, which will not be done. The third cohort (1-2L) will will have the shorter follow-up period (24 weeks) and will attend visits 1 to 7 except for V4, which will not be done. Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 55 years
- Gender
- Both males and females
Description
After being informed of the study and the potential risks, all patients matching the eligibility criteria and who have given their written consent will undergo a gel injection at day 0 after a period of screening of up to 14 days. Then, they will be followed-up for a variable period according to the...
After being informed of the study and the potential risks, all patients matching the eligibility criteria and who have given their written consent will undergo a gel injection at day 0 after a period of screening of up to 14 days. Then, they will be followed-up for a variable period according to the cohort : first cohort of 5 patients with only one disc to be treated will be followed during 48 weeks, second cohort of 5 patients with 2 discs to be treated will be followed during 36 weeks, third cohort of 10 patients with 1 or 2 discs to be treated will be followed during 24 weeks.
Tracking Information
- NCT #
- NCT04727385
- Collaborators
- Excelya
- Investigators
- Not Provided
Get Well Soon