Health Condition 1: M959- Acquired deformity of musculoskeletal system, unspecified
Conditions
Interventions
Intervention1: Nimulid Strong Gel: Gel should be rubbed gently into the skin. Depending on the size of the affected
site to be treated 2-4g of gel should be applied 2 times daily (preferably morning
Sponsors
Mankind Pharma Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Male or Female subject age between 18-65 years (both inclusive) 2) Subject suffering from pain associated with recent muscle or joint injuries such as sprains, strains, or sports injuries within 24 hours of visit. 3) Pain Intensity score of >=5 on an 11-point NRS, at rest or during movement unilateral grade I or II acute sprain. 4) Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form. 5) Females of childbearing potential, using an effective contraceptive method for at least one month before the beginning of the study, and willing to use throughout the study.
Exclusion criteria
Exclusion criteria: 1) Subject has treated the pain with treatment such as oral or other topical pain relief medications, massage or physical therapy since experiencing the sprain, strains, or sports injuries. 2) Acute or chronic pain disorders, which may confound the study pain evaluations 3) Subject noted to have grade III sprain or fracture 4) Subjects having recent history (within one year) of alcohol or other substance abuse as determined by medical history. 5) More than one injuries on same limb. 6) Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit. 7) Previous participation in similar study with similar products within 30 days. 8) Subject has any visible skin disease at the site of application that, in the opinion of the investigator, will interfere with the skin assessments. 9) Subject has current or relevant previous history of serious, severe or unstable physical or psychiatric illness, or medical disorders, such as current or previous history of hepatic or renal diseases (impairment) or peptic ulcer as determined by medical history. 10) Subject has a history of hypersensitivity (e.g. asthma, bronchospasm, rhinitis, urticarial, nasal polyps), allergy, intolerance or contraindication to aspirin, diclofenac, other non-steroidal anti-inflammatory drugs (NSAIDs), menthol or any of the excipients in the test product(s). 11) Pregnant and breastfeeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Pain intensity measurement: Pain intensity on movement will be measured by a 11 point Numerical Pain Rating Scale (NPRS) from 0 (no pain) to 10 (extreme pain). 2) Pain Intensity Difference (PID) on movement [Time Frame: Baseline to 7 days] 3) Pain Intensity Difference (PID) at rest [Time Frame: up to 72 hours] 4) Sum of Pain Intensity Difference (SPID) [Time Frame: Baseline to Day 7] 5) Pain Relief Score (PRS) [Time Frame: Baseline to Day 7]. 6) Time of Onset of Pain Relief (TOPR) [Time Frame: Baseline to 7 days (end of study)] 7) Time of Onset of Meaningful Pain Relief (TOMR) [ Time Frame: up to 7 days (end of study)] 8) Total Pain Relief (TOTPAR) [ Time Frame: Baseline to 168 hours ] 9) Time of Onset of Cooling Sensation[Time Frame: Baseline to 8 hours ] 10) Time to complete Recovery [ Time Frame: Baseline to Day 7]Timepoint: 8 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Mean Cumulative irritation scoreTimepoint: 8 days;2) Skin TemperatureTimepoint: Baseline to 10, 30, 60 minutes, and 4 and 8 hours.;3) Patients Global Assessment in Response to Treatment (PGART)Timepoint: Up to Day 7;4) Frequency and intensity of AEs Timepoint: 8 days | — |
Countries
India
Contacts
Public ContactDr Milan Satia
Ethicare Clinical Trial Service
Outcome results
None listed