E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate intervertebral disc degeneration without radiculopathy |
Moderat intervertebral diskus degeneration uden udstrålende smerter |
|
E.1.1.1 | Medical condition in easily understood language |
Moderate arthrosis/low back pain |
Moderat lænderygssmerter uden smerter i benene. |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10025020 |
E.1.2 | Term | Lumbosacral spondylosis without myelopathy |
E.1.2 | System Organ Class | 100000004859 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To improve low back pain and disc hydration |
Forbedre lænderygssmerter og vandindhold i diskus |
|
E.2.2 | Secondary objectives of the trial |
To improve disc nutrition by diffusion Improve bone morphogenesis in surrounding vertebrae |
Forbedre er næring via diffusion til diskus Forbedre knoglekvaliteten i omkringliggende ryghvirvler |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Low back pain without radiculopathy Moderate disc degeneration (Pfirrmann Grdae 2-3) |
lænderygssmerter uden udstråling Moderat diskus degeneration (Pfirrmann Grad 2-3) |
|
E.4 | Principal exclusion criteria |
Disc herniation Spondylolisthesis (Grade 2 or more) |
Diskus prolaps Spondylolistese (Grda 2 eller mere) |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Oswestry Disability Index SF-36 Dallas Pain Questionaire MRI |
Oswestry Disability Index SF-36 Dallas Pain Questionaire MR skanning |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
6 weeks 12 weeks 24 weeks 1 year 2 years |
6 uger 12 uger 24 uger 1 år 2 år |
|
E.5.2 | Secondary end point(s) |
Diffusion into the disc Bone morphogenesis of vertebrae |
Ernæring via diffusion til diskus Knoglekvalitet i ryghvirvler |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
6 weeks 12 weeks 24 weeks 1 year 2 years |
6 uger 12 uger 24 uger 1 år 2 år |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Fysioterapi |
Standard physiotheray |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Trial is finished when the last included patient has been followed for 2 years |
Forsøget afsluttes når den sidst inkluderede patient er fulgt i 2 år |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |