Health Condition 1: L298- Other pruritus
Conditions
Interventions
Intervention1: Hydroxyzine Hydrochloride: 50mg
Sustain Release formulation
Once daily orally
1 month treatment period
Control Intervention1: NA: NA
Sponsors
Dr Reddys Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosed with chronic pruritus (pruritus of more then 6 weeks) Patients who are prescribed with Hydroxyzine and plan for up dosing to Hydroxyzine HCl 50 mg SR tablets or patients who require Hydroxyzine HCl 50 mg SR tablets (higher dose) or newly prescribed to Hydroxyzine HCl 50 mg SR tablets and Non responders to topical and SGA (second-generation antihistamine) therapy Patients with Numerical rating scale itch score of 7 to 10 (inclusive)
Exclusion criteria
Exclusion criteria: Mild and moderate pruritus due to a primary dermatologic or all other causes other than dermatological causes like systemic psychogenic and neuropathic Patients on systemic immunomodulatory agents and anti depressant Those receiving any centrally acting medication or those with known neurological conditions will be excluded from the study Patients with a known history of cardiovascular disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the NRS itch score in chronic pruritus subjects on Hydroxyzine HCl 50 mg SR tablets from screening visit (baseline) to follow-up visits at week 1 and week 4. Change in DLQI measured in chronic pruritus subjects on Hydroxyzine HCl 50 mg SR tablets from screening visit (baseline) to follow-up visits at week 1 and week 4Timepoint: Week 1 week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) in terms of symptoms, signs, and laboratory assessment Timepoint: Week 1 week 2 week 4 | — |
Countries
India
Contacts
Public ContactPratik Shah
Dr Reddys Laboratories Limited
Outcome results
None listed