Painful osteoarthritic first metatarsophalangeal joint (hallux rigidus) MedDRA version: 20.0 Level: LLT Classification code 10019092 Term: Hallux rigidus System Organ Class: 100000004859
Conditions
Interventions
Trade Name: Flector Unidie®
Product Name: FLECTOR UNIDIE
Product Code: [038354015]
Pharmaceutical Form: Medicated plaster
INN or Proposed INN: piroxicam 14 mg
CAS Number: 36322-90-4
Current Sponsor co
Sponsors
IBSA INSTITUT BIOCHIMIQUE SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria at the screening visit (Visit 1) 1. Outpatients of both genders, aged = 45 years; 2. Diagnosis of hallux rigidus, i.e.: - Persistent pain of the first MTPJ during normal daily activities while on movement present for = 1 year; - Narrowed joint space and osteophytes of the first MTPJ in plan X-rays (performed at screening or within 6 months prior to screening); 3. Pain while walking scored = 4 (on a 0-10 NRS). In case of bilateral OA of the first MTPJ that satisfies this criterion in both sides, the foot with the highest NRS score for pain at screening (Visit 1) will be selected as target foot for assessments (treatment of the non-target foot will be left at the discretion of the treating Investigator); 4. Female subjects of childbearing potential (i.e., not status post hysterectomy or tubal ligation) must be using an appropriate method of contraception according to the definition of Note 3 of ICH M3* throughout the study and for 7 days after the last dose; 5. Female subjects must have a negative urine pregnancy test at inclusion; 6. Subject having provided their written informed consent to study participation. Inclusion criteria at the baseline visit (Visit 2) 7. Pain while walking scored = 4 (on a 0-10 NRS) in the target foot is to be confirmed; 8. Change (i.e. increase or reduction) = 2.0 points on a 0-10 NRS in Pain while walking as compared to the Screening visit (Visit 1). *A highly effective method is defined as that which results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly. Highly effective birth control methods include: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomised partner; sexual abstinence. 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: Exclusion criteria at the screening visit (Visit 1) 1. Pregnant or lactating women; 2. Diagnosis of hallux rigidus associated with a medical condition other than idiopathic OA of the first MTPJ; 3. Non-intact or damaged skin (e.g., eczema, psoriasis, exudative dermatitis, infected lesion, burn or wound) within the area to be treated with the medicated plaster; 4. Presence of neuropathy of the target or contralateral foot (i.e. positive Semmes-Weinstein 10g Monofilament test); 5. Diabetes mellitus and glycated haemoglobin (HbA1c) > 64 mmol/mol (regardless of treatment) at screening or within 3 months prior to inclusion; 6. History of rheumatoid arthritis, gout or other inflammatory arthritis of the foot; 7. Hallux valgus angle >30° in weight-bearing X-ray; 8. Hallux varus in weight-bearing X-ray; 9. Presence of pain in passive manipulation of ipsilateral first toe interphalangeal joint; 10. Presence of severe circulatory disorder of the lower limb: i.e., absence of palpable pulses in the foot (both dorsalis pedis artery and tibialis posterior artery). 11. History of surgery of the foot in question; 12. Activity limiting symptoms from an earlier fracture or ligament injury of the foot; 13. Subject not amenable to topical treatments; 14. Prior use of neuropathic analgesics for the treatment of neuropathic pain of the target or contralateral foot; 15. Use of any topical medication to involved area within 24 hours prior to the screening visit (Visit 1); 16. Use of over-the-counter (OTC) analgesic or non-steroidal anti-inflammatory drugs (NSAIDs) (e.g., diclofenac, ibuprofen, ketoprofen) within 48 hours prior to the screening visit (Visit 1) (paracetamol is permitted). 17. Use of long-acting NSAIDs (e.g., piroxicam or naproxen) within 72 hours prior to the screening visit (Visit 1); 18. Use of narcotic analgesics within 7 days prior to the screening visit (Visit 1). 19. Use of systemic anti-inflammatory steroidal drugs, by any route of administration, within 60 days prior to the screening visit (Visit 1); 20. Use of immunomodulators or immunosuppressive therapies or interferon within 30 days prior to the screening visit (Visit 1); 21. Known allergy or hypersensitivity to piroxicam, aspirin or other NSAIDs, including paracetamol, or any excipient in the tested products; 22. History and/or presence of: - asthma, urticaria, angioedema, or bronchospasm; - ulcer disease, gastrointestinal bleeding, inflammatory bowel disease; - coagulation defects, hemorrhagic diathesis; - severe hepatic or renal impairment; - severe cardiac/cardiovascular conditions, including NYHA Class III and IV congestive heart failure (CHF), and unstable, uncontrolled hypertension; - any chronic pain disorder; - severe systemic disease (e.g., cancer, severe acute infection); 23. Heavy-worker subjects or subjects that wear safety shoes for their usual daily activities; 24. Major psychiatric disorders that, according to the Investigator, could compromise the subject’s participation in the study; 25. History of alcohol or drug abuse (within the previous 12 months); 26. Subjects refusing to give a written informed consent; 27. Concomitant participation in other clinical trials or participation in the evaluation of any investigational product during 3 months before this study or previous participation in the same study; 28. Participation in the study is also not permitted to employees of the Investigator or study site with direct involvement in the trial or in othe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to assess the rate of subjects experiencing substantial pain reduction (measured using a numeric rating scale, NRS) following an 8-day period of once-a-day (24h) IP, as compared to baseline (pre-treatment) pain level.;Secondary Objective: The secondary objectives of the study are: •To assess the evolution of pain and disability over the period of treatment with the IP and after a subsequent period of follow-up (without plaster application); •To assess the effect of treatment with the IP on the range of motion (ROM) of the affected hallux MTPJ over the period of IP treatment and after a subsequent follow-up period (without plaster application); •To assess the subject’s satisfaction at the end of IP treatment. •To assess the local and general safety of the IP, by recording of the adverse events and serious adverse events occurred during the study;Primary end point(s): The primary efficacy endpoint of the study will be the proportion of responders, defined as a reduction in pain while walking =30% at the end of treatment as compared to baseline value. Pain while walking, (i.e., pain as perceived by the subject while walking at least 10 steps on an even surface) will be self-assessed by the subjects at site using a 0-to-10 numerical rating scale (NRS) at baseline (Visit 2/Day 1) before applying the first plaster, and then every day from Day 2 to Day 8 (approximately at the same time every day, around noon, while wearing the medicated plaster) in their personal Diary. Assessment at the end of the treatment period (Visit 3/Day 8) will be performed with the plaster still in place.;Timepoint(s) of evaluation of this end point: Value at the end of treatment as compared to baseline value (before the application of the first plaster) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ROM of the target hallux MTPJ measured using a goniometer recorded at baseline (Visit 2/Day 1), before applying the first plaster, at the end of the treatment period (Visit 3/Day 8) as well as at the end of the follow-up period (Visit 4/Day 15); Pain at night, as self-assessed by the subject using a 0-to-10 NRS during in-clinic visits at baseline (Visit 2/Day 1), before applying the first plaster, at the end of the treatment period (Visit 3/Day 8) as well as at the end of the follow-up period (Visit 4/Day 15).; Subject’s satisfaction with the treatment received expressed at the end of the treatment period (Visit 3/Day 8), by answering the question: How satisfied have you been with your big toe considering your daily activities and pain this week?’ using a 7-item Likert scale from 7 = ‘very satisfied’ to 1 = ‘very unsatisfied’.; Pain while walking (as defined above), as self-assessed by the subject using a 0-to-10 NRS during in-clinic visits at baseline (Visit 2/Day 1), before applying the first plaster, at the end of the treatment period (Visit 3/Day 8) as well as at the end of the follow-up period (Visit 4/Day 15).; Subject’s opinion on the medicated plaster ease of use expressed at the end of the treatment period (Visit 3/Day 8), using a 0-100 mm VAS, anchored to 0=not easy at all, and to 100=extremely easy; Investigator’s judgment of global efficacy, as assessed at the end of the treatment period (Visit 3/Day 8) using a 5-item verbal scale (4 = excellent, 3 = good, 2 = fair, 1 = poor, 0 = none).; Overall pain during the usual daily activities, as self-assessed by the subject using a 0-to-10 NRS during in-clinic visits at baseline (Visit 2/Day 1), before applying the first plaster), at the end of the treatment period (Visit 3/Day 8) as well as at the end of the follow-up period (Visit 4/Day 15).; Subject’s opinion on the level of disability expressed at the end of the treatment period (Visit 3/Day 8), by answering the question: How much the | — |
Countries
Italy
Contacts
Public ContactR&D Dept.
* B.4.2 - Specificare il nome dell'organizzazione IBSA Institut Biochimique S.A. * B.4.3 - Paese 100000000536
Outcome results
None listed