A randomized, double-blind, multi-center, placebo-controlled, parallel group study to evaluate the efficacy and safety of diclofenac sodium topical gel 1% applied four times daily in subjects with acute blunt soft tissue injuries/contusions of the limbs
- Conditions
- Acute blunt soft tissue injuries/contusions of the limbsMedDRA version: 12.1Level: LLTClassification code 10050584Term: Contusion
- Registration Number
- EUCTR2010-020936-21-DE
- Lead Sponsor
- ovartis Consumer Health S.A.
- 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. Suffering from fresh impact injury (blunt, traumatic soft tissue injury or contusion) of the upper or the lower limbs, not requiring admittance to hospital.
3. Anticipated time between injury and treatment must be less than 3 hours.
4. Pain-on-movement (POM) = 50 mm on a 100 mm VAS (section 7.5.1).
5. Tenderness reaction of contralateral uninjured site must be at a pressure 1.5 fold higher than at the injured area, with an absolute sensitivity to pain on the contralateral site of at least 2.5 kp/cm2.
6. The size of the traumatisation must be at least 25 cm2 and at most 150 cm2.
7. Satisfactory health as determined by the Investigator based on medical history and physical examination.
8. Give 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Pain medication was taken within the 6 hours that precede randomization. Stable 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. Safety laboratory values with clinically significant abnormalities (as defined in Appendix 14.1 of the protocol). The Investigator will exercise clinical judgment in order to interpret the clinical significance of any abnormal value.
3. Women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) who are not using an acceptable method of contraception defined as:
·Surgical sterilization
·Hormonal contraception
·IUD
·Double barrier method
·Total abstinence throughout the study at the discretion of the Investigator.
Periodic abstinence is NOT an acceptable method of contraception. An acceptable method of contraception must be maintained throughout the study.
4.Pregnant or nursing (lactating) women.
5.Any physical impairment that would influence the study’s efficacy evaluations, in particular POM such as: peripheral or central neurological disease, significant back pain; in case of acute blunt soft tissue injuries of the lower limbs: symptomatic osteoarthritis of the hips, knees, or feet, or any other painful conditions of the lower extremities (e.g., painful nail, wound, corn, or wart), in case of acute blunt soft tissue injuries of the upper limbs: no painful conditions of the upper extremities.
6.Intent to undergo surgery during time of study participation.
7.Any skin lesion or wound or infection in the area to be treated.
8.Topical analgesic or anti-inflammatory treatment over the previous month in the area to be treated.
9.History of allergy (cutaneous or systemic), hypersensitivity, or asthma to any of the following: diclofenac, paracetamol, acetylsalicylic acid, salicylic acid, other NSAID or cyclooxygenase 2-specific inhibitor (COXIB) or known intolerance (cutaneous or systemic) to any of the ingredients in the gel, such as isopropyl alcohol or propylene glycol.
10.Chronic or acute renal or hepatic disorder, inflammatory bowel disease (e.g., Crohn’s disease or ulcerative colitis), or a significant coagulation defect.
11.History of active or suspected esophageal, gastric, pyloric channel, or duodenal ulceration or bleeding within 30 days preceding screening.
12.History of clinically significant cardiovascular, cerebrovascular, metabolic, pulmonary, neurological, hematological, autoimmune, psychiatric or endocrine disorders, including individuals with Type I or Type II diabetes.
13.History of uncontrolled chronic or acute concomitant disease which, in the Investigator’s opinion, would contraindicate study participation or confound interpretation of the results.
14.Uncontrolled psychiatric disease or history of known narcotic, analgesic, or alcohol abuse.
15.Any cognitive impairment that would, in the opinion of the Investigator, preclude study participation or compliance with study procedures (e.g., Alzheimer’s dementia).
16.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.
17.Previous participation in this clinical study.
18.Participation in any other clinical st
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 sodium topical gel (DSG) 1% applied four times a day compared with placebo in subjects with acute blunt, soft tissue injuries/contusions of the limbs.<br><br>;Secondary Objective: To assess the safety of DSG 1% compared with placebo applied four times daily for up to seven days.;Primary end point(s): The primary efficacy outcome is pain-on-movement (POM) assessed by Visual Analogue Scale (VAS) at Visit 4 (24 hours after initiating treatment). <br>
- Secondary Outcome Measures
Name Time Method