E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute upper and low back pain as described in the note for guidance on clinical investigation of medical products for treatment of Nociceptive Pain. |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000683 |
E.1.2 | Term | Acute back pain |
|
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 |
The primary objective of this trial is to show that Kytta-Salbe® f is superior to placebo ointment as assessed by time-specific pain intensity difference in the indication of upper and low back pain.
The primary efficacy variable of this trial is the back pain on active standardised movement, patient’s assessment on Visual Analogue Scale (VAS). The pain intensity on a Visual Analogue Scale is assessed at performance of standardised, muscle group specific tests.
|
|
E.2.2 | Secondary objectives of the trial |
Back pain on rest, patient’s assessment on VAS. Pressure algometry in the trigger point. Global assessment of efficacy by patient. Global assessment of efficacy by the investigator. Consumption of analgesic medication. Functional impairment measured with the Oswestry Disability Index. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Age range 18-60 years. 2. Good general condition. 3. Written informed consent. 4. Acute back pain (either upper or low back pain), not in combination. 5. Sensitivity to algometric pressure on the site contralateral to the painful trigger point at least 2.5 N/cm². 6. Basic value of the pressure algometry on the trigger point shall not exceed 50% of the respective value of the site contralateral to the painful trigger point. |
|
E.4 | Principal exclusion criteria |
1. Upper or low back pain that is attributable to any identifiable cause (e. g. disc prolapse, spondylolisthesis, osteomalacia, or inflammatory arthritis). 2. Any recent trauma. 3. Any recent strains of the back muscles documented by the clinical evaluation and anamnesis. 4. Chronic back pain. 5. Likelihood of prolapsed spinal disc documented by clinical symptoms (pain irradiation to peripheral areas, paraesthesia, clinically detectable impairment of muscle strength of related areas). 6. Back pain caused by metabolic or neurological diseases documented by anamnesis (i.e. toxic neuropathy). 7. Diabetes Mellitus. 8. Risk factors for spinal infection. 9. Recent onset of bladder dysfunction or severe or progressive neurological deficit in the low extremity (as a possible indication of prolapsed disk). 10. Concomitant use of any anti-inflammatory drugs, heparinoids or analgesics including herbal preparations (glucocorticosteroids, NSAIDs, etc.) for the same indication or other indications (e.g. rheumatoid arthritis). 11. Analgesics or NSAIDs/corticoid drugs applied by any route of administration within 10 days of study entry or corticoid drugs applied by any route of administration within 60 days of study entry. 12. Any other concomitant treatment or medication, that interferes with the conduct of the trial. 13. Known intolerance or hypersensitivity (allergy) to the trial treatments, including known toxic reactions. 14. Local skin affections that do not allow the application of the test ointment. 15. Participation in a clinical trial within the previous 30 days before enrolment in the trial, participation in this study before or simultaneous participation in another clinical trial. 16. Pregnancy or lactation period. 17. Women with childbearing potential without an effective contraceptive method. 18. Abuse of alcohol, medicaments or illicit drugs. 19. Any patient in the investigator’s opinion not considered suitable for enrolment. 20. Legal incapacity or limited legal capacity to give informed consent. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary variable is the area under the curve (AUC) of the Visual Analogue Scale (VAS) values measured at Visits 1, 2, 3, and 4. |
|
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
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 | Information not present in EudraCT |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |