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| Name | Class |
|---|---|
| NEA Clinical S.r.l. | UNKNOWN |
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The purpose of this study is to assess the safety, tolerability and efficacy of CetilarĀ®
After being informed about the study, all patients giving written informed consent will undergo no more than a 1-week screening period to determine eligibility for study entry. Patients that meet inclusion criteria and do not have exclusion criteria will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to CetilarĀ® cream (about 5 g, twice per day) or placebo cream (about 5 g, twice per day).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group (CetilarĀ®) | Experimental | Participants received CetilarĀ® topical cream twice daily for 30 days. An average amount of 5 g per day |
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| Control group (Placebo) | Placebo Comparator | Participants received Cetilar Placebo topical cream twice daily for 30 days. An average amount of 5 g per day |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CetilarĀ® (topical cream) | Device | Topical cream twice daily for 30 days. An average amount of 5 g per day. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in FAAM (Foot and Ankle Ability and Measure) total score questionnaire on day 30 | FAAM is a validated questionnaire assessing mobility and functionality on Day 30. Change = (Day 30 - Baseline Score). This instrument includes 2 subscales:
Answers for both scales are based on a Likert scale (4-0) of: 4) "no difficulty" 3) "slight difficulty" 2) "moderate difficulty" 1) "extreme difficulty" 0) "unable to do" If an activity in question was limited by something other than their ankle, the patient was asked to record N/A To calculate the score for either subscale, the total number of points are added, divided by the total number of possible and then multiplied by 100. Therefore, a higher score reflects a higher level of physical function. | From Baseline to Day 30 |
| Change From Baseline in Pain on the Visual Analogue Scale (VAS scale) on day 30 | Visual analogue scale (VAS) is a validated questionnaire assessing pain intensity on Day 30. Possible scores range from 0 cm (no pain) to 10 cm (Pain as bad as it could be). Change = (Day 30 - Baseline Score). | From Baseline to Day 30 |
| Change From Baseline in QoL (Quality of Life) total score questionnaire on day 30 | QoL is a validated questionnaire assessing taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, general mental health, social functioning, energy/fatigue, and general health perceptions on Day 30. Change = (Day 30 - Baseline Score). Scale scores represent the average for all items in the scale that the patients answered. | From Baseline to Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| The number and % of patients with treatment-emergent adverse events | Incidence and severity of adverse events (AEs) that occurred during the treatment. | From Baseline to Day 30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Sole Rossato | Pharmanutra S.p.a. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LLC "Altra Vita" | Tbilisi | 0160 | Georgia | |||
| JSC "Evex Hospitals" (Caraps Medline) |
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| ID | Term |
|---|---|
| D016512 | Ankle Injuries |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| Cetilar Placebo | Device | Cetilar placebo cream matching to CetilarĀ®. Topical cream twice daily for 30 days. An average amount of 5 g per day |
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| Tbilisi |
| Georgia |
| Azienda Sanitaria Locale Viterbo | ASL Viterbo, Dipartimento di Ortopedia (Centro Coordinatore) | Viterbo | 01100 | Italy |