E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 |
The objective of this multi-center randomized, double-blind, placebo-controlled trial is to evaluate the analgesic efficacy and safety of flurbiprofen patch for chronic (lasting greater than three months) LBP. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients will be considered eligible for entry into the Baseline Phase (Visit 1) of the study if the following inclusion criteria are satisfied. 1. Patient must have given his/her written informed consent to participate in the study after receiving adequate previous information and prior to any study specific procedures 2. Patient must be able to understand and follow instructions and to participate in the study for the entire period 3. Patient is male or female 18 to 80 years of age, inclusive at the time of Visit 1 4. Patient has a Body Mass Index (BMI) of 18-32 kg/m², inclusive at screening, and a total body weight ≥ 55 kg 5. Female patients must be postmenopausal (defined as two years without menses), physically incapable of becoming pregnant, or using an acceptable birth control method. Acceptable methods of birth control with a low failure rate (less than 1%) are such as implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs), or double-barrier methods (condom or diaphragm with spermicidal agent or IUD), sexual abstinence or vasectomised partner. Non-postmenopausal patients must have confirmation of a negative pregnancy test at Visit 1. 6. Patient has had daily LBP below the 12th thoracic vertebra of greater than three months’ duration 7. Patient is able to ambulate at least 100 meters 8. Patient is in stable general health with screening laboratory values within two times the upper limit of normal 9. Patient has a diagnosis of chronic LBP verified by appropriate medical records, as needed 10. Male patients must use an acceptable method of birth control with their female partners 11. Patient has had average LBP over the prior week (7 days) to Visit 1 of grade 4 or higher on an eleven point Categorical Pain Scale
Patients must meet all previous inclusion criteria as well as the additional following criteria to be eligible for randomization into Patch Treatment Phase (Visit 2): 12. Patient has, over the last three days of the Baseline Phase, a computed average pain score of 5 or higher on an eleven point Categorical Pain Scale as identified in his/her Baseline Daily Diary 13. Patient has not used anticonvulsants, NSAIDs, and muscle relaxants from Visit 1 through the Baseline Phase. Paracetamol dose of ≤ 3000 mg/day is acceptable
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E.4 | Principal exclusion criteria |
A patient is not eligible for participation in the study if any of the following exclusion criteria are met at the screening visit. 1. Patient has participated in another clinical trial during the preceding 30 days of study entry 2. Patient has donated approximately 500 ml blood or more in the preceding 4 weeks 3. Patient has had a febrile illness within 1 week before the start of the study 4. Patient has a history of clinically significant allergies including drug allergies 5. Patient has a history of allergic response(s) to flurbiprofen, other non-steroidal analgesic drugs (NSAID) or related drugs 6. Patient has a history of known sensitivities to adhesives and/or to inactive constituents of the FP 7. Patient has an open skin lesion within the painful area 8. Patient has undergone back surgery within the past three months or has plans for back surgery within 30 days post-study 9. Patient has chronic back pain which is due to fibromyalgia or connective tissue disorder (lupus, rheumatoid arthritis, ankylosing spondylitis, Reiter’s syndrome, etc.) 10. Patient has LBP due to malignancy, vertebral fracture, or infection 11. Patient has used anticonvulsants within 30 days before randomization for treatment (if used for pain) and throughout the study 12. Patient is using NSAIDs, and muscle relaxants from screening through the end of study participation (Paracetamol dose of ≤ 3000 mg/day is acceptable) 13. Patient has used opioids (including low potency/low dose opioid combinations and tramadol) more than two times per week within 30 days of study entry. Opioids and tramadol must be discontinued at least four days prior to study entry 14. Patient has had injection therapy within 30 days of study entry, including corticosteroids 15. Patient has a clinically significant psychiatric disorder (severe depression, other Axis I or Axis II disorders as defined in DSM-IV) 16. Patient is taking lithium, furosemide, and/or thiazides 17. Pregnant or lactating women 18. Patient is considered unreliable as to medication compliance or adherence to scheduled appointments as determined by the investigators 19. Patient has a prior history of gastrointestinal bleeds/ulcers or clinically significant liver/kidney disease 20. Patient has a coagulation disorder or is taking warfarin or other anticoagulants [a low dose of acetylic salicylic acid (≤ 100 mg) is acceptable] 21. Patient has clinically significant fluid retention, asthma, cardiovascular disease (CVD), hypertension, or heart failure 22. Patient has had coronary artery bypass surgery (CABG), cardiovascular thrombotic event, myocardial infraction (MI) and/or stroke within one year of Visit 1 23. Patient has unresolved litigation related to back injury or other pain complaints; however, settled disability claims/payments (Worker’s Compensation, state/federal/private disability plans) are allowed 24. Patient has a history of drug or alcohol addiction or abuse within the past year. Alcohol abuse defined as >14 drinks per week (1 drink= 360 ml beer, 120 ml wine, or 45 ml distilled spirits) 25. Patient is an employee or at least dependent of an investigator and/or the sponsor or of an institution directly involved in the study or other trials under the investigator’s direction
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy variables will be the Cumulative Summed Pain Intensity Difference (SPID) at days 4 and 7 of the Patch Treatment Phase. The SPID will be calculated for each patient from the patient Treatment Daily Diary entries of the Categorical Pain Scale score and is defined as the weighted sum of the pain intensity differences from Patch Treatment Phase day 1 to Patch Treatment Phase days 4 and 7 (study day 7 to study days 10 and 13). |
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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 | 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) | 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 | 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 | 10 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 10 |
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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Completion of the last subject |
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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 |