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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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

Other trials in China

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 groups in NCT05763550
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.

27 Feb 20237 Aug 2023

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Comparison Between the Efficacy of Ultrasound-guided Erector Spinae Plane Block and Conventional Treatment for Pain Management in Patients With Post-herpetic Neuralgia
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Assessing Symptom and Mood Dynamics in Pain Using the Smartphone Application SOMA
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All Herpetic Neuralgia trials

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.

Related trials for Herpetic Neuralgia

Active, not recruiting
Transcranial Magnetic Stimulation for Chronic Neuropathic Pain
Chronic Neuropathic Pain, Post-Stroke Pain
Recruiting
Closed-Loop Deep Brain Stimulation for Refractory Chronic Pain
Spinal Cord Injuries, Nerve Injury
Recruiting
Comparison Between the Efficacy of Ultrasound-guided Erector Spinae Plane Block and Conventional Treatment for Pain Management in Patients With Post-herpetic Neuralgia
Post-Herpetic Neuralgia
RecruitingObservational study
Assessing Symptom and Mood Dynamics in Pain Using the Smartphone Application SOMA
Chronic Pain, Acute Pain
Not yet recruitingPhase 4
Ketamine for Postherpetic Neuralgia With Depression
Depression Disorders, Herpetic Neuralgia

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?

On the ClinicalTrials.gov record for NCT05763550.

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; AzTrials last refreshed its copy on 8 Nov 2026.