To Evaluate the Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Herpetic Neuralgia
- Summary
- Investigate the efficacy and safety of HSK16149 capsules in Chinese herpetic Neuralgia following 4 weeks treatment in comparison to pregabalin.
- Short title
- To Evaluate the Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Herpetic Neuralgia
- Official title
- A Multicenter, Randomized, Double-Blind, Double-Dummy , Pregaballin-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of HSK16149 Capsules in Chinese Patients With Herpetic Neuralgia
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2023-08-07
- First posted
- 2023-03-10
- Registry last updated
- 2023-11-08
- Primary completion date
- 2023-06-22
- Start date
- 2023-02-27
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05763550
- ClinicalTrials.gov ID
- NCT05763550
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Double masking
- Masked roles
- Participants, Investigators
Compare the change from baseline in Numeric Rating Scales(NRS )between HSK16149 and pregabalin at week 4
Timeframe: Baseline and week 4
Numeric Rating Scales(NRS )was a 11-point numeric rating scale ( 0\[no pain\] to 10 \[worst possible pain\]
Compare the response rate between HSK16149 and pregabalin at week 4 (Proportion of subjects whose NRS decreased by ≥30% and≥ 50% from baseline )
Timeframe: Baseline and week 4
Compare the change from baseline in VAS between HSK16149 and pregabalin at week 4
Timeframe: Baseline and week 4
VAS, in which the participant rates pain on a 100 mm-long horizontal line, where 0 mm = no pain and 100 mm = worst possible pain
Compare the change from baseline in DSIS between HSK16149 and pregabalin at week 4
Timeframe: Baseline and week 4
The sleep interference scores on a scale of 0-10, where 0 = pain did not interfere with sleep to 10 = pain completely interfered with sleep.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
- Signed informed consent;
- Males or females aged 18 years and older ;
- Patients must have herpetic neuralgia;
- At Screening, pain scale (VAS) of ≥ 40 mm;
- At Screening, pain scale (NRS) of ≥ 4.
- Patients have pain present for more than 1 months after the healing of the herpes zoster skin rash;
- AST/ALT > 2 × upper limit of normal (ULN), or TBIL≥1.5 × ULN;
- Serum Creatine > 176μmol/L;
- Any active infections at screening;
- History of allergic or medically significant adverse reaction to investigational products or their excipients, pregabalin or related compounds;
- Participated in another clinical study within 30 days prior to screening;
- Pregnant or breastfeeding at screening ;
- Other conditions unlikely to participate in this trial.
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, China