Postherpetic Neuralgia ( PHN )
Conditions
Brief summary
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).
Interventions
DRUGHL-1186
HL-1186 tablet for oral administration
DRUGHL-1186 placebo
HL-1186 placebo tablet for oral administration
Pregabalin capsule for oral administration
DRUGPregabalin capsule placebo
Pregabalin capsule placebo for oral administration
Sponsors
Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged ≥ 18 years, of either sex. 2. Pain persists for 1 month or more after healing of skin lesions in patients with herpes zoster. 3. 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.
Exclusion criteria
1. Participants with any pain other than PHN, or with other diseases that the researcher considers to potentially affect the evaluation of PHN. 2. 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. 3. Participants who have used drugs that may damage nerves (such as tumor chemotherapy drugs) after being diagnosed with PHN. 4. The baseline NRS collection begins within the 5 half-lives following the last use of the prohibited drug. 5. Participants who have previously used pregabalin with inadequate efficacy or intolerance. 6. Clinically significant abnormalities in the 12-lead electrocardiogram (ECG) during the screening period, or complicated with severe cardiopulmonary diseases, which are deemed unsuitable for inclusion by the researcher. 7. Participants with a history of malignant tumors within 2 years prior to screening. 8. Participants who have undergone major surgery within 8 weeks prior to enrollment or plan to undergo any surgery during the trial period. 9. Participants with positive human immunodeficiency virus antibody, positive syphilis serological test, positive hepatitis B virus surface antigen with hepatitis B virus DNA \> ULN, or positive hepatitis C virus antibody with hepatitis C virus RNA \> ULN. 10. Participants with a history of alcoholism or drug abuse within 2 years before screening. 11. Female participants who are pregnant, breastfeeding (within 1 year after delivery), or with a positive pregnancy test. 12. Participants deemed by the investigator to be unsuitable for participating in this trial for any reason.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Average Daily Pain Score (ADPS) from baseline after 12 weeks of administration | Day 1 to Day 84 | 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) |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | Day 1 to Day 98 |
Countries
China
Contacts
CONTACTRenhai Yang
Outcome results
None listed