Health Condition 1: R51- Headache
Conditions
Interventions
None listed
Sponsors
Sun Pharmaceutical Industries Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects of either sex aged 18 ââ?¬â?? 80 years. 2. Subjects who are able to understand written and/or verbal instructions and are ready to comply with all study requirements with a willingness to participate and give written informed consent voluntarily. 3. Subjects who are diagnosed with tension-type headache as per The International Classification of Headache Disorders 3rd edition (ICHD-3) criteria. 4. Subjects with pain score ââ?°Â¥ 4/10 (based on numeric pain rating scale) during the past 1 week.
Exclusion criteria
Exclusion criteria: 1. Women of child bearing potential who are either unwilling or unable to use an acceptable method of birth control [such as oral contraceptives, other hormonal contraceptives (implants or injectable products, vaginal products, skin patches), or IUDs, barrier methods] to avoid pregnancy during the study period. 2. Pregnant or lactating subjects 3. Subjects diagnosed with secondary type of headache disorders and other type of primary headache disorders as per ICHD-3 criteria. 4. Known allergy to compounds of test product. 5. Subjects suffering from medical or psychiatric conditions that would increase the risk of adverse events or interfere with study assessments. 6. Participation in an investigational drug trial during the last 30 days. 7. Immuno-compromised (history) individuals like known HIV positive subjects or subjects who are on treatment with steroids or immunomodulators. 8. Subjects of vulnerable group (e.g. seriously ill, mentally challenged). 9. History of drug or alcohol abuse during the last 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to onset of relief of painTimepoint: 0-120 minutes | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to onset of cooling/warmth/tingling/burning sensation 2. Time to achieve complete relief of pain 3. Reduction in pain score on numeric pain rating scale 4. Time interval between onset of pain relief and the need for second application of test product for pain relief [Time frame: 0-24 hours] 5. Subjectââ?¬â?¢s overall satisfaction for pain relief on a 7- point Likert Satisfaction scale [Time Frame: on day 2 post dose] 6. User perception will be assessed with a 7- point Likert Satisfaction scale on the following points: 1. Ease of application, 2. Stickiness 3. Greasiness and 4. Ease of spreading. [Time Frame: on day 2 post dose] 7. Adverse events (AE) and serious adverse events (SAE) [Time frame: 0-24 hours]Timepoint: 30 seconds, 1 minute, 2 minutes, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes, 120 minutes post dose and upto 24 hrs. | — |
Countries
India
Contacts
Public ContactDr Ramesh Kannan
KI3, CRO
Outcome results
None listed