Double-blind, placebo-controlled, randomised, parallel-groups, multi-centre clinical trial for the evaluation of efficacy and safety of an ointment of comfrey extract in comparison to placebo in the treatment of acute upper or low back pai
- Conditions
- 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 version: 8.1Level: LLTClassification code 10000683Term: Acute back pain
- Registration Number
- EUCTR2006-003621-87-DE
- Lead Sponsor
- Merck Selbstmedikation GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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.<br><br>The primary efficacy variable of this trial is the back pain on active standardised movement, patient’s assessment on Visual Analogue Scale (VAS).<br>The pain intensity on a Visual Analogue Scale is assessed at performance of standardised, muscle group specific tests.<br><br>;Secondary Objective: Back pain on rest, patient’s assessment on VAS.<br>Pressure algometry in the trigger point.<br>Global assessment of efficacy by patient.<br>Global assessment of efficacy by the investigator.<br>Consumption of analgesic medication.<br>Functional impairment measured with the Oswestry Disability Index. ;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.
- Secondary Outcome Measures
Name Time Method