E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
ankle sprain Grade I or II |
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MedDRA Classification |
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 evaluate the efficacy of diclofenac diethylamine (DDEA) 2.32% twice or three times a day in patients with acute ankle sprains under "in-use" conditions, in particular with regard to pain relief after the first 5 days of treatment and recovery of function.
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E.2.2 | Secondary objectives of the trial |
To assess the safety of DDEA 2.32% twice or three times a day for one week under "in-use" conditions. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female aged 18 years and over.
2. Women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) as long as they are using an acceptable method of contraception defined as: • Surgical sterilization • Hormonal contraception • IUD • Double barrier method • Total abstinence throughout the study at the discretion of the Investigator. Periodic abstinence is NOT acceptable. An acceptable method of contraception must be maintained throughout the study. A women who is post menopausal must have a negative urine pregnancy test at screening but will not need to comply with an acceptable method of contraception.
3. Acute sprain of the lateral ankle, Grade I-II (Appendix 14.1 Protocol). 4. Injury within past 12 hours. 5. No pain medication may have been taken within the 12 hours that precedes randomization. Treatment by rest, ice, compression, or elevation (RICE) is authorized prior to randomization. Stable doses of acetylsalicylic acid (≤ 162 mg) taken for at least 30 days prior to the first dose of study medication for non-analgesic reasons may be continued for the duration of the study. 6. Pain-on-movement (POM) ≥ 50 mm on a 100 mm VAS (section 7.4.1 Protocol). 7. Satisfactory health as determined by the investigator based on medical history and physical examination. 8. Capacity to give informed consent. 9. Voluntarily sign and date the informed consent form, approved by an IRB/IEC, prior to the conduct of any study specific procedures. |
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E.4 | Principal exclusion criteria |
1. Any concurrent injury affecting the lower extremities that is painful at rest or on movement, or could affect the mobilization of the patient. 2. Topical analgesic or anti-inflammatory treatment over the previous month in the area to be treated. 3. During the past 3 months: Grade I-III sprain of the same ankle. 4. During the past 6 months: Grade II-III sprain, any other significant injury (such as fracture or torn ligament), or surgery (except for skin or nails) of the same ankle or foot. 5. Pain or instability in the same ankle attributable to previous ankle sprain or any other trauma. 6. Ankle sprain attributable to a known disease affecting the ligaments, such as ligament hyperlaxity due to connective tissue disease (e.g., Marfan's syndrome, Down's syndrome, Ehlers-Danlos syndrome). 7. Any skin lesion or wound in the area to be treated. 8. Intent to undergo surgery during time of study participation. 9. Pregnant or breastfeeding woman. 10. History of allergy (cutaneous or systemic), hypersensitivity, or asthma to any of the following: diclofenac, paracetamol, acetylsalicylic acid, salicylic acid, other NSAID or cyclooxygenase 2-specific inhibitor (COXIB) or known intolerance (cutaneous or systemic) to any of the ingredients in the gel, such as oleyl alcohol, isopropyl alcohol, or propylene glycol. 11. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases. 12. Chronic or acute renal or hepatic disorder, inflammatory bowel disease (e.g., Crohn’s disease or ulcerative colitis), or a significant coagulation defect. 13. History of active or suspected esophageal, gastric, pyloric channel, or duodenal ulceration or bleeding within 30 days preceding screening. 14. History of clinically significant cardiovascular, cerebrovascular, metabolic, pulmonary, neurological, hematological, autoimmune, psychiatric or endocrine disorders, including individuals with Type I or Type II diabetes. 15. History of uncontrolled chronic or acute concomitant disease which, in the investigator's opinion, would contraindicate study participation or confound interpretation of the results. 16. Uncontrolled psychiatric disease or history of known narcotic, analgesic, or alcohol abuse. 17. Previous participation in this clinical study. 18. Participation in any other clinical study within 30 days prior to the enrollment. 19. Any physical impairment that would influence the study's efficacy evaluations, in particular POM and the ankle joint function, such as: peripheral or central neurological disease, significant back pain, symptomatic osteoarthritis of the hips, knees, or feet, or any painful conditions of the lower extremities (e.g., painful nail, wound, corn, or wart). 20. Any cognitive impairment that would, in the opinion of the investigator, preclude study participation or compliance with study procedures (e.g., Alzheimer's dementia).
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy outcome is pain-on-movement on VAS after 5 days of treatment (Visit 3) tested in the intent-to-treat population |
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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 | 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 | 6 |
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
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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 | |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |