E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute back pain or acute neck pain |
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E.1.1.1 | Medical condition in easily understood language |
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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 | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000683 |
E.1.2 | Term | Acute back pain |
E.1.2 | System Organ Class | 100000019085 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10028836 |
E.1.2 | Term | Neck pain |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
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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 assess the efficacy and tolerability of a topical formulation gel of the
combination of diclofenac and capsaicin in comparison to gels with diclofenac
alone, capsaicin alone, and placebo for the treatment of acute back pain or neck
pain.
The primary objective of this trial is to demonstrate superior efficacy of a
formulation containing a combination of 2% diclofenac and 0.075% capsaicin
over placebo and over formulations containing 2% diclofenac alone and
0.075% capsaicin alone for the treatment of acute back or neck pain. |
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E.2.2 | Secondary objectives of the trial |
A secondary objective is to assess the safety and tolerability of the combination of diclofenac and capsaicin in comparison to gels with diclofenac alone, capsaicin alone |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Signed and dated written informed consent at Visit 1 in accordance with Good Clinical Practice and local legislation
- Male or female patients >=18 years with current diagnosis of acute back pain or of neck pain for at least 24 hours, but less than 21 days
- Acute back pain or acute neck pain resulting in pain on movement (POM) = 50 mm (Visual Analogue Scale 0-100) for at least one POM procedure out of 5 standardized procedures.
- Sensitivity to algometric pressure on the painful trigger point <= 25 N/cm2
- Women of childbearing potential must be ready and able to use highly effective methods of birth control
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E.4 | Principal exclusion criteria |
- History of 3 or more episodes of back or neck pain in the last 6 months excluding the current episode
- Surgery due to back or neck pain or rehabilitation due to back or neck pain in the last 12 months
- Back or neck pain that is attributable to any specific identifiable cause (e.g. disc prolapse, spondylolisthesis, osteomalacia, inflammatory arthritis, metabolic, neurological diseases or tumour)
- Trauma or strains of the back or neck muscles within the last 3 months
- Prior use within the last 3 days before Visit 1 or concomitant use of any anti-inflammatory drugs, heparinoids, muscle relaxants or analgesics. Long-acting glucocorticoids must have been discontinued 10 days before study entry. Spinal injections should have been discontinued in due time (investigator's judgement) before patient enrolment to allow complete wash-out of the active ingredient based on investigator's judgment
- Non-pharmacological treatment (physiotherapy, heat treatment (e.g. heat patch, hot water bottle), or massage, acupuncture, transcutaneous electrical nerve stimulation) or locally applied pharmacological product to the back or neck area 24 hours prior study entry and during the study period
- Known severe hepatocellular insufficiency, severe renal insufficiency or Gilbert's syndrome (Morbus Meulengracht)
- Any other medical condition that would interfere with efficacy and safety assessments based on investigator's judgement or any on-going clinical condition that would jeopardize patient's or site personnel's safety or study compliance based on investigator judgement.
- Known intolerance or hypersensitivity to the active ingredients or any excipient(s).
- Patients in whom attacks of asthma, bronchospasm, rhinitis or urticaria were precipitated by the intake of ASS or other NSAIDs
- Irritated skin (based on investigator's judgement), skin wounds, eczema or open injuries at application site
- Negative experience in the past with heat treatments for muscle complaints
- Patient not able to understand and comply with trial requirements based on investigators judgement
- Alcohol or drug abuse
- Participation in a clinical trial within the previous 30 days or simultaneous participation in another clinical trial
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial |
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E.5 End points |
E.5.1 | Primary end point(s) |
1: Change in pain on movement (POM) between baseline and Day 2 evening, 1 hour after drug application (Visit 3) with regard to the POM of the procedure which gave the highest score at baseline (POM of worst procedure, POM-WP)
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1: Area under the cuve of POM-WP assessed until Day 4 morning, i.e. 72 hours after start of treatment. AUC will be calculated as area under the curve from zero to 72 hours using the trapezoidal rule divided by the observation time
2: Area under the curve of POM-WP assessed until Day 6 morning, i.e. 120 hours after start of treatment. AUC will be calculated as area under the curve from zero to 120 hours using the trapezoidal rule divided by the observation time
3: Number of patients with a decrease in POM-WP of at least 30% from baseline on Day 2 evening, 1 hour after drug application (Visit 3)
4: Number of patients with a decrease in POM-WP of at least 50% from baseline on Day 2 evening, 1 hour after drug application (Visit 3)
5: Change in POM-WP between baseline and the morning of Day 6 (Visit 6)
6: Change in Pressure Algometry (PA) between baseline and Day 2 evening, before drug application (Visit 3)
7: Change in PA between baseline and the morning of Day 6 (Visit 6)
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1: 72 hours
2: 120 hours
3: 36 hours
4: 36 hours
5: 120 hours
6: 36 hours
7: 120 hours
6: 36 hours
7: 120 hours
6: 36 hours
7: 120 hours
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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) | 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 | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 4 |
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 | 16 |
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 | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |