Health Condition 1: M708- Other soft tissue disorders related to use, overuse and pressure
Conditions
Interventions
Intervention1: Aceclofenac IP 1.5 % w/w, Linseed oil(containing predominantly α Linolenic acid 3 % w/w, methyl salicylate IP 10 % w/w, capsaicin USP 0.01 % w/w, menthol IP 5 % w/w, Benzyl alcohol
Sponsors
Panacea Biotec Pharma Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or non-pregnant female patients aged between 18-65 years with a clinical diagnosis of acute pain in musculoskeletal conditions. 2.Patients with single site painful acute musculoskeletal conditions (tendinitis, bursitis, myalgia, low back-ache, sprains, pulled muscle, soft tissue injury etc.) sustained within 48 hours of screening (not requiring surgical treatment). 3.Patients with at least moderate pain at rest of Numeric rating Scale (NRS) greater or equal to 4. 4.Patient is able to provide written informed consent prior to study. 5.Willingness to comply with the study schedule and procedures. 6.If female, patient must be either postmenopausal for at least one year prior to randomization, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or practicing the following methods of birth control: a) Oral Contraceptives or Intrauterine Device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or b) Double Barrier methods containing or used in conjunction with a spermicidal agent, or c) Contraceptive Patches/ Implants, or d) Abstinence: Subjects who will be practicing abstinence will agree to have an acceptable method of birth control if the subject becomes sexually active during the course of her study participation. 7. All male subjects must agree to use accepted methods of birth control with their partners during the study. Abstinence is an acceptable method of birth control. Any of the following methods of birth control are acceptable: oral contraceptives, contraceptive patches/implants (e.g., Norplant®), Depo-Provera®, double barrier methods (e.g., condom and spermicide) or IUD.
Exclusion criteria
Exclusion criteria: 1. Patients with any condition which in opinion of the investigator makes the patient unsuitable for inclusion. 2. Patients with painful muscle spasms associated with musculoskeletal systems, which need parenteral therapy / surgery / hospital admission for management. 3. Patient with history of osteoarthritis / rheumatoid arthritis. 4. Patients with skin wounds, open injuries or other conditions of broken skin at the site of proposed application. 5. Use of any oral or topical analgesic or anti-inflammatory treatment within 1 week prior to study screening. 6. Patients with history of severe cardiac, hepatic, gastrointestinal, renal, pulmonary and skin diseases. 7. Known hypersensitivity to Aceclofenac or any other ingredient of product or to rescue medication acetaminophen (Paracetamol). 8. Patient is a female who is pregnant or willing to get pregnant, not ready to use contraceptive measures during the trial period or breast feeding. 9. Participation in any other clinical trial during last 90 days. 10. History of regular fever, headaches which warrants frequent use of acetaminophen (Paracetamol) or NSAIDS 11. Elevated transaminases (>= 3 times ULN) and hemoglobin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy end point pertaining to Pain intensity at rest (Based on NRS) will be assessed by comparing Pain intensity (at rest) in both the arms.Timepoint: [Time frame: Baseline (day o) to day 8] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall clinical response based on 50% relief in patient pain. 2. Pain intensity at rest (Based on NRS). 3. Pain intensity on passive movement (Based on NRS) 4. Physicians & Patient Global Assessment Scale. 5. Need for rescue medication 6. Safety assessmentTimepoint: Baseline to day 4 & day 8. Baseline to day 4. Baseline to day 4 & day 8. Baseline to day 4 & day 8. Baseline to day 4 & day 8. Baseline to day 4 & day 8. | — |
Countries
India
Contacts
Public ContactDr Lalitendu Mohanty
Panacea Biotec Pharma Ltd
Outcome results
None listed