A randomized, multicenter, double-blind study assessing the efficacy and safety of two topical 10% naproxen gel formulations in the treatment of benign soft-tissue injuries. - Efficacy and Safety of topical Naproxen gel on benign soft tissue injuries

• Conditions: Benign soft-tissue injuries.; MedDRA version: 13.1Level: PTClassification code 10028391Term: Musculoskeletal painSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

• Registration Number: EUCTR2010-024641-71-IT
• Lead Sponsor: ANGELINI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-23
• Last Update Posted: 28 August 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Male or female subjects aged 18 to 70 years, with no limitation of race. Female patients with childbearing potential should have a negative pregnancy test and should not be breastfeeding (see Section 9.1.2). Male and female patients should use an appropriate birth control method. 2. Benign soft-tissue injury (closed injuries, sprains, strains and contusions) of upper (including shoulders but excluding fingers and toes) or lower limbs and tendinitis occurred within 48 hours before the randomization, and not requiring hospitalization. Patients included in the study will be requested to avoid any solicitation on the injured area including, but not limited to, any kind of mechanical stress. Injured area must be not greater than 250 cm2. 3. Pain during daily activities = 35 mm on a 100 mm VAS (according to Huskisson method, Huskisson 1974 and 1982), and spontaneous pain at rest = 35 mm on a 100 mm VAS (according to Huskisson method, Huskisson 1974 and 1982) and [Esparza 2007]). 4. Subjects legally capable to give their consent to participate in a clinical study. A written informed consent to participate to the trial must be signed and dated by the patient prior to the inclusion in the study.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Hypersensitivity and/or allergy to naproxen, acetylsalcylic acid (or other NSAIDs), paracetamol, or positive history for any drug allergy. 2. Hypersensitivity and/or allergy to any of the eccipients contained in the Momendol preparation, Naprosyn preparation (such as metabisulfite) or Paracetamol tablets (refer to each relevant SPC). 3. Contraindications to Paracetamol according to the SPC (Appendix 3), including serious forms of hemolytic anemia , severe hepatocell insufficiency, phenilketonuria, G6PD insufficiency 4. Positive history for blood coagulation disorders or treatments with anti-coagulants 5. Soft-tissue injury associated with open wounds in the area to be treated. 6. Expected sunlight exposure (including UV sunbed) of the treated area during the whole study period (including the follow-up period) 7. Pregnant or nursing women 8. Concomitant conditions that in the Investigator’s judgement can jeopardize the safe participation of the subject in the study, including, but not limited to, severe renal or liver failure, cardiovascular pathologies, pulmonary pathologies, endocrine disorders. 9. Presence of an orthopedic splint and brace denying not only free movements but also the application of the study treatments on the injured area. 10. Any kind of benign soft-tissue injury involving fingers and toes. 11. Diagnosis of fracture, requiring or not immobilization. 12. A diagnosis of asthma in acute stage, regardless to treatment conditions. 13. A suspected diagnosis of gastric ulcers and/or erosions in acute phase . 14. Positive history for local (area of injury) skin disorders and/or chronic dermatological conditions 15. Positive history for drugs and alcohol abuse. Will be excluded also patients who had an acute alcohol or drugs abuse episode within 24 h before the randomization in the present study. 16. Use of any topic pain relieving agents (including but not limited to corticosteroids, NSAIDs and topical anesthetics) within the previous 48 hours before the randomization. Cooling will be allowed as an emergency intervention on the injury, but study treatment will be administered after at least 3 hours from the pain assessment. 17. Use of any systemic pain relieving agents within the previous 48 hours before the randomization. 18. Soft-tissue injury requiring hospitalization. 19. Inability to comply with the protocol requirements, instructions and study-related restrictions; e.g., uncooperative attitude, inability to return for study-visits, and improbability of completing the clinical study. 20. Vulnerable subjects (e.g. persons kept in detention). 21. If Subject is the Investigator or his(her) deputies, first grade relative, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the study. 22. Participation in an investigational clinical study within 3 months prior to the screening/baseline visit. 23. Painfull conditions derived from chronic deseases such as gout, arthritis, reumathoid arthritis.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of the study is to assess the efficacy and safety of Momendol? gel (naproxen 10%) in comparison with the reference marketed product Naprosyn? gel (naproxen 10%) in the treatment of benign soft-tissue injuries.;Secondary Objective: ;Primary end point(s): The primary efficacy endpoint will be the change in pain during daily activities after the 7-day treatment period.