Clinical study to evaluate the efficacy and safety of diclofenac potassium 25 mg tablets in subjects with acute joint pai
- Conditions
- ankle sprain, grade I - IIMedDRA version: 14.1Level: LLTClassification code 10002549Term: Ankle sprainSystem Organ Class: 10022117 - Injury, poisoning and procedural complicationsTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2011-005577-23-DE
- Lead Sponsor
- ovartis Consumer Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1.Male or female aged 18 years and over.
2.Acute sprain of the lateral ankle, Grade I-II
3.Injury within past 12 hours.
4.Pain-on-movement (POM) = 50 mm on a 100 mm VAS .
5.Satisfactory health as determined by the Investigator based on medical history and physical examination.
6.Written informed consent before any assessment is performed.
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 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
1.Pain medication was taken within the 6 hours that precede randomization. Stable daily 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. Treatment by rest, ice, compression, or elevation (RICE) is permitted.
2.Women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) who are not using an acceptable method of contraception
3.Pregnant or nursing (lactating) women.
4.During the past 3 months: Grade I-III sprain of the same ankle.
5.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.
6.Pain or instability in the same ankle attributable to previous ankle sprain or any other trauma.
7.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).
8.Any concurrent injury affecting the lower extremities that is painful at rest or on movement, or could affect the mobilization of the subject.
9.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).
10.Intent to undergo surgery during time of study participation.
11.Topical analgesic or anti-inflammatory treatment over the previous month in the injured area.
12.Any other concomitant treatment including cosmetics, ointment at the injured area or medication that interferes with the conduct of the trial.
13.History of allergy (cutaneous or systemic), hypersensitivity, or asthma to any of the following: diclofenac, acetaminophen (paracetamol), acetylsalicylic acid, salicylic acid, other NSAID or cyclooxygenase 2-specific inhibitor (COXIB).
14.Chronic or acute renal or hepatic disorder, inflammatory bowel disease (e.g., Crohn’s disease or ulcerative colitis), or a significant coagulation defect.
15.History of active or suspected esophageal, gastric, pyloric channel, or duodenal ulceration or bleeding within 30 days preceding screening.
16.History of clinically significant cardiovascular, cerebrovascular, metabolic, pulmonary, neurological, hematological, autoimmune, psychiatric or endocrine disorders, including individuals with Type I or Type II diabetes.
17.History of uncontrolled chronic or acute concomitant disease which, in the Investigator’s opinion, would contraindicate study participation or confound interpretation of the results.
18.Uncontrolled psychiatric disease or history of known narcotic, analgesic, or alcohol abuse.
19.Any cognitive impairment that would, in the opinion of the Investigator, preclude study participation or compliance with study procedures (e.g., Alzheimer’s dementia).
20.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.
21.Previous participation in this clinical study.
22.Participation in any other clinical study within one month prior to the enroll
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of diclofenac potassium 25 mg tablet taken 3 times a day compared with placebo in subjects with acute ankle sprains under ‘in-use’ conditions, in particular with regard to pain relief.<br>•The primary outcome for healing is ankle pain-on-movement (POM) assessed by Visual Analogue Scale (VAS) at Visit 4 (48 hours (±4h) after initiating treatment).<br>;Secondary Objective: To assess the safety of diclofenac potassium 25 mg tablet compared with placebo taken three times a day for 4 days under ‘in-use’ conditions. ;Primary end point(s): The primary efficacy outcome for healing is ankle pain-on-movement (POM) assessed by Visual Analogue Scale (VAS) at Visit 4 (48h ± 4 h hours after initiating treatment).;Timepoint(s) of evaluation of this end point: Visit 4 (48h ± 4 h hours after initiating treatment).
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • POM on VAS at Visits 2, 3 and 5<br>• Spontaneous pain intensity at Visit 2<br>• Tenderness measured by pressure algometry at Visits 3, 4 and 5 <br>• Ankle joint function (Karlsson Scoring Scale) at Visits 3, 4 and 5.<br>•Circumference measurement of swelling (compared to non-affected side) by Figure-of-eight-method” at Visits 3, 4 and 5.<br>• Global efficacy assessments at Visit 5 <br>• Response to treatment: POM reduced by 50% at Visit 4, Yes/No.<br><br>;Timepoint(s) of evaluation of this end point: • POM on VAS at Visits 2, 3 and 5<br>• Spontaneous pain intensity at Visit 2<br>• Tenderness measured by pressure algometry at Visits 3, 4 and 5 <br>• Ankle joint function (Karlsson Scoring Scale) at Visits 3, 4 and 5.<br>•Circumference measurement of swelling (compared to non-affected side) by Figure-of-eight-method” at Visits 3, 4 and 5.<br>• Global efficacy assessments at Visit 5 <br>• Response to treatment: POM reduced by 50% at Visit 4, Yes/No.<br><br>