This is a multicenter, randomized, double-blind, double-dummy, placebo- and active-controlled, parallel-group trial to evaluate the safety, efficacy and pharmacokinetic (PK) profile of HL-1186 Tablet in patients with postherpetic neuralgia (PHN).
Aged ≥ 18 years, of either sex.
Pain persists for 1 month or more after healing of skin lesions in patients with herpes zoster.
Participants fully understand the purpose, characteristics, methods of the trial and possible AEs, voluntarily participate in the trial and sign the ICF, or have their legal guardian sign the ICF on their behalf.
Participants with any pain other than PHN, or with other diseases that the researcher considers to potentially affect the evaluation of PHN.
Participants who may be allergic to the active ingredients or excipients of HL-1186 Tablet, HL-1186 Tablet placebo, pregabalin capsule or pregabalin capsule placebo, have an allergic constitution, or have a history of allergies to ≥ 3 substances.
Participants who have used drugs that may damage nerves (such as tumor chemotherapy drugs) after being diagnosed with PHN.
The baseline NRS collection begins within the 5 half-lives following the last use of the prohibited drug.
Parallel
HL-1186
DrugHL-1186 tablet for oral administration
HL-1186 placebo
DrugHL-1186 placebo tablet for oral administration
Pregabalin capsule
DrugPregabalin capsule for oral administration
Pregabalin capsule placebo
DrugPregabalin capsule placebo for oral administration
Change in the Average Daily Pain Score (ADPS) from baseline after 12 weeks of administration
ADPS = sum of NRS scores within 7 days / number of times the form is filled out NRS (Numeric Rating Scale, 0 =no pain to 10 =worst possible pain)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
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