Herpetic NeuralgiaPhase 2NCT05763550
To Evaluate the Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Herpetic Neuralgia
A Phase 2 study testing HSK16149 20mg BID, HSK16149 40mg BID and Pregabalin 150mg in people with Herpetic Neuralgia, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
Investigate the efficacy and safety of HSK16149 capsules in Chinese herpetic Neuralgia following 4 weeks treatment in comparison to pregabalin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Herpetic Neuralgia
- What is being tested?
- HSK16149 20mg BID, HSK16149 40mg BID and Pregabalin 150mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 331 participants
- Where
- 1 siteChina
- Study dates
- 27 Feb 2023to 7 Aug 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
About this study
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
Investigate the efficacy and safety of HSK16149 capsules in Chinese herpetic Neuralgia following 4 weeks treatment in comparison to pregabalin.
- Conditions
- Herpetic Neuralgia
- Being tested
- HSK16149 20mg BID, HSK16149 40mg BID, Pregabalin 150mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK16149 20mg BIDDrug
HSK16149 20mg, orally twice a day, treatment period; 4-weeks fixed dose.
HSK16149 40mg BIDDrug
HSK16149 40mg, orally twice a day, treatment period; 4-weeks fixed dose.
Pregabalin 150mgDrug
pregabalin, orally twice a day, treatment period; 150 mg (75 mg twice daily) for 1 week；300 mg (150 mg twice daily) daily for 3 week
| Study group | Role | What they receive |
|---|---|---|
| HSK16149 20mg BID | Experimental | Not described Receives: Drug: HSK16149 20mg BID |
| HSK16149 40mg BID | Experimental | Not described Receives: Drug: HSK16149 40mg BID |
| Pregabalin 150mg BID | Active comparator | Not described Receives: Drug: Pregabalin 150mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the change from baseline in Numeric Rating Scales(NRS )between HSK16149 and pregabalin at week 4
Numeric Rating Scales(NRS )was a 11-point numeric rating scale ( 0[no pain] to 10 [worst possible pain]
Measured: Baseline and week 4
Secondary outcomes (3)
Compare the response rate between HSK16149 and pregabalin at week 4 (Proportion of subjects whose NRS decreased by ≥30% and≥ 50% from baseline )
Measured: Baseline and week 4
Compare the change from baseline in VAS between HSK16149 and pregabalin at 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
Measured: Baseline and week 4
Compare the change from baseline in DSIS between HSK16149 and pregabalin at 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.
Measured: Baseline and week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start27 Feb 2023
- Primary completion22 Jun 2023
- Study completion7 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpetic NeuralgiaStudies of the same condition, open and under way.
- More trials run by Haisco Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 331 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fangqiong Li, Study chair, Haisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05763550
- Sponsor's protocol ID
- HSK16149-205
- Status last verified
- Feb 2023
- First submitted
- 28 Feb 2023
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05763550
- Acronym / sponsor ID
- HSK16149-205
- Conditions
- Herpetic Neuralgia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 331 participants (actual)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 22 Jun 2023 (actual)
- Study completion
- 7 Aug 2023 (actual)
- First posted
- 10 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigate the efficacy and safety of HSK16149 capsules in Chinese herpetic Neuralgia following 4 weeks treatment in comparison to pregabalin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HSK16149 20mg BID | Experimental | Drug: HSK16149 20mg BID |
| HSK16149 40mg BID | Experimental | Drug: HSK16149 40mg BID |
| Pregabalin 150mg BID | Active comparator | Drug: Pregabalin 150mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HSK16149 20mg BIDHSK16149 20mg, orally twice a day, treatment period; 4-weeks fixed dose. | Drug | HSK16149 20mg BID |
| HSK16149 40mg BIDHSK16149 40mg, orally twice a day, treatment period; 4-weeks fixed dose. | Drug | HSK16149 40mg BID |
| Pregabalin 150mgpregabalin, orally twice a day, treatment period; 150 mg (75 mg twice daily) for 1 week；300 mg (150 mg twice daily) daily for 3 week | Drug | Pregabalin 150mg BID |
Primary outcome
Compare the change from baseline in Numeric Rating Scales(NRS )between HSK16149 and pregabalin at week 4
Time frame: Baseline and week 4
Numeric Rating Scales(NRS )was a 11-point numeric rating scale ( 0[no pain] to 10 [worst possible pain]
3 secondary outcomes
Compare the response rate between HSK16149 and pregabalin at week 4 (Proportion of subjects whose NRS decreased by ≥30% and≥ 50% from baseline )
Time frame: Baseline and week 4
Compare the change from baseline in VAS between HSK16149 and pregabalin at week 4
Time frame: Baseline and week 4
Compare the change from baseline in DSIS between HSK16149 and pregabalin at week 4
Time frame: Baseline and week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fangqiong Li study chair
Haisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HSK16149 20mg BID, HSK16149 40mg BID and Pregabalin 150mg in people with Herpetic Neuralgia, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the change from baseline in Numeric Rating Scales(NRS )between HSK16149 and pregabalin at week 4 (time frame: Baseline and week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.