Diabetic Peripheral Neuropathic PainPhase 2/3NCT04647773

To Evaluate the Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Diabetic Peripheral Neuropathic Pain

A Phase 2/3 study testing HSK16149 20mg BID, HSK16149 40mg BID and HSK16149 60mg BID in people with Diabetic Peripheral Neuropathic Pain, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Investigate the efficacy and safety of HSK16149 capsules in Chinese diabetic peripheral neuropathic pain (DPNP) following 13 weeks treatment in comparison to placebo. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Diabetic Peripheral Neuropathic Pain
What is being tested?: HSK16149 20mg BID, HSK16149 40mg BID and HSK16149 60mg BID
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 687 participants
Where: 1 siteChina
Study dates: 2 Dec 2020to 16 Nov 2022
Phase: Phase 2/3
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Signed informed consent;
Males or females aged 18-75 years of age inclusive;
Diagnosis of diabetic peripheral neuropathic pain (DPNP) and diabetic peripheral neuropathy (DPN) pain ≥ 6 months;
HbA1c ≤ 9.0% at screening and on a stable antidiabetic medication regimen for at least 30 days prior to screening;
At Screening, pain scale (VAS) of ≥40 mm and <90 mm.

Who cannot join

Peripheral neuropathy or pain unrelated to DPN that may confuse the assessment of DPNP.
Skin conditions in the area affected by neurupathy that could alter sensation.
Chronic systemic diseases that may affect subjects' participation in the study.
Severe hematologic, hepatic or renal dysfunction, the subject will be excluded if:
Neutrophils < 1.5 × 10^9/L, or platelet < 90 × 10^9/L, or hemoglobin < 100 g/L, or
AST/ALT > 2.5 × upper limit of normal (ULN), or TBIL > 1.5 × ULN, or

Show all 20Show fewer

Estimation of glomerular filtration rate (eGFR) < 60 mL/min / 1.73 m^2, or
Creatine kinase > 2.0 × ULN.
History of substance abuse or alcohol abuse.
Acute complications of diabetes in the 6 months prior to screening.
Any active infections at screening.
HBsAg or HCV Ab positive, or HIV Ab positive, or serum TP Ab positive.
Inability or unwillingness to discontinue any other prohibited concomitant medications (see Section 6.3).
Failure to response to previous treatment with pregabalin at doses ≥ 300 mg/d or gabapentin at doses ≥ 1200 mg/d for treatment of DPNP.
History of allergic or medically significant adverse reaction to investigational products or their excipients, acetaminophen or related compounds.
History of suicidal behavior or attempted suicide.
Pregnant or preparing for pregnancy or breastfeeding during the study period, or subjects were not willing to use reliable contraceptives methods from the date of ICF signature until 28 days after the last trial drug administration, or planning to use progesterone contraceptives during this period.
Participated in another clinical study within 30 days prior to screening.
Other conditions of the subjects who are unlikely to comply with the protocol.
Could potentially affect a subject's safety.

Trial locations and contacts

1 site in 1 country.

Fangqiong Li contact

+8602867258840

lifangq@haisco.com

China1 site

Peking University First Hospital
Beijing, Beijing Municipality, 100034
Xiaohui Guo, M.D., 13601337277, guoxh@medmail.com.cn

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo- and Pregabalin Capsule-Controlled, 13-Week, Adaptive-design Phase 2/3 Study to Evaluate the Efficacy and Safety of HSK16149 Capsules in Chinese Patients With Diabetic Peripheral Neuropathic Pain

Investigate the efficacy and safety of HSK16149 capsules in Chinese diabetic peripheral neuropathic pain (DPNP) following 13 weeks treatment in comparison to placebo.

Conditions: Diabetic Peripheral Neuropathic Pain
Being tested: HSK16149 20mg BID, HSK16149 40mg BID, HSK16149 60mg BID, HSK16149 80mg BID, Pregabalin 150mg BID

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; 13-weeks fixed dose.
HSK16149 40mg BIDDrug
HSK16149 40mg, orally twice a day, treatment period; 13-weeks fixed dose.
HSK16149 60mg BIDDrug
HSK16149 60mg, orally twice a day, treatment period; 1-week titration and 12-weeks fixed dose.
HSK16149 80mg BIDDrug
HSK16149 80mg, orally twice a day, treatment period; 1-week titration and 12-weeks fixed dose.
Pregabalin 150mg BIDDrug
Pregabalin 150mg, orally twice a day, treatment period; 1-week titration and 12-weeks fixed dose.
Placebo BIDDrug
Placebo, orally twice a day, treatment period; 13-weeks fixed dose.

Study groups in NCT04647773
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
HSK16149 60mg BID	Experimental	Not described Receives: Drug: HSK16149 60mg BID
HSK16149 80mg BID	Experimental	Not described Receives: Drug: HSK16149 80mg BID
Pregabalin 150mg BID	Active comparator	Not described Receives: Drug: Pregabalin 150mg BID
Placebo BID	Placebo comparator	Not described Receives: Drug: Placebo BID

What is being measured

The primary outcome is the main question the study is designed to answer.

Compare the change from baseline in Average Daily Pain Score（ADPS） between HSK16149 and placebo at week 5.
The mean change in average daily pain score (ADPS) was measured using a 11-point numeric rating scale (NRS; 0 [no pain] to 10 [worst possible pain]. The rating averaged over a 7-day period and was based on entries in patients' daily pain diaries.
Measured: Baseline and week 5
Compare the change from baseline in Average Daily Pain Score （ADPS） between HSK16149 and placebo at week 13.
The mean change in average daily pain score (ADPS) was measured using a 11-point numeric rating scale (NRS; 0 [no pain] to 10 [worst possible pain]. The rating averaged over a 7-day period and was based on entries in patients' daily pain diaries.
Measured: Baseline and week 13

Secondary outcomes (11)

Compare the response rate between HSK16149 and placebo at week 5 (Proportion of subjects whose ADPS decreased by ≥30% and ≥50% from baseline ).
Ratio of Participants Responding to Treatment, as Measured by Average Daily Pain Score (ADPS) Reduction from Baseline. The ADPS is used to determine categorical response rates.
Measured: Baseline and week 5
AE, laboratory tests, physical and neurological examination, vital signs and 12-lead ECG to evaluate the safety of HSK16149 in 5 weeks post treatment.
Number and severity of AEs, clinical laboratory abnormalities, physical examinations, 12-lead electrocardiograms (ECGs), and vital signs.
Measured: From week 1 to week 5
Compare the response rate between HSK16149 and placebo at week 13 (Proportion of subjects whose ADPS decreased by ≥30% and ≥50% from baseline ).
Ratio of Participants Responding to Treatment, as Measured by Average Daily Pain Score (ADPS) Reduction from Baseline. The ADPS is used to determine categorical response rates.
Measured: Baseline and week 13
Compare the change from baseline in ADPS between HSK16149 and placebo at week 1 to 13.
The mean change in average daily pain score (ADPS) was measured using a 11-point numeric rating scale (NRS; 0 [no pain] to 10 [worst possible pain]. The rating averaged over a 7-day period and was based on entries in patients' daily pain diaries.
Measured: From week 1 to week 13
Compare the change from baseline in Visual Analog Scale （VAS） between HSK16149 and placebo at week 13.
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 13
Compare the change from baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) between HSK16149 and placebo at week 13.
Participants rate their pain in three parts of the questionnaire, which are combined into a single pain intensity score:
Part 1 - fifteen descriptors of pain intensity, on a scale of 0 (none) to 3 (severe)
Part 2 - a visual analog scale (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
Part 3 - a Present Pain Intensity index in which the participant rates present pain intensity on a scale of 0 (no pain) to 5 (most intense pain)
Measured: Baseline and week 13
Compare the Patient Global Impression of Change（PGIC） between HSK16149 and placebo at week 13.
Patient global impression of change (PGIC) on a 7-point categorical scale, where 1 = very much improved and 7 = very much worse.
Measured: Week 13
Compare the change from baseline in Average Daily Sleep Interference score (ADSIS) between HSK16149 and placebo at week 13.
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. The weekly ADSIS is based on participants daily sleep interference scores.
Measured: Baseline and week 13
Compare the change from baseline in EuroQol-5-Domain-5-Level health questionnaire (EQ-5D-5L) between HSK16149 and placebo at week 13.
The change from baseline in total EuroQol-5-Domain-5-Level health questionnaire.
Measured: Baseline and week 13
AE, laboratory tests, physical and neurological examination, vital signs and 12-lead ECG to evaluate the safety of HSK16149 during the trial.
Number and severity of AEs, clinical laboratory abnormalities, physical examinations, 12-lead electrocardiograms (ECGs), and vital signs.
Measured: From week 1 to week 14
Pharmacokinetic (PK) characteristics of HSK16149 capsules in Chinese patients with diabetic peripheral neuropathic pain.
Pharmacokinetics will be determined by measuring serum concentration of HSK16149.
Measured: Week 1,week 5,week 11,week 13

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Dec 202016 Nov 2022

First posted1 Dec 2020
Study start2 Dec 2020 (estimated)
Primary completion9 Nov 2022 (estimated)
Study completion16 Nov 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Diabetic Peripheral Neuropathic PainStudies 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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 687 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04647773
Sponsor's protocol ID: HSK16149-201/301
Status last verified: Nov 2020
First submitted: 16 Nov 2020
Last updated: 1 Dec 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Pan T, Ma J, Li Y, Wang K, Jiang C, Zhang Y, Liu J, Du R, Zhang W, Bian F, Zhang F, Wang L, Pang S, Ning T, Wang B, Li Y, Wu X, Zhang K, Tang X, Hu H, Sun X, Li P, Cheng Z, Sun J, Yang J, Wang Y, Gao J, Mao H, Li F, Huang Q, Li Y, Peng Z, Guo X. Rapid Onset of Pain Relief with Crisugabalin in Patients with Diabetic Peripheral Neuropathic Pain: Findings from a Multicenter, Randomized, Double-Blind, Controlled Study. Pain Ther. 2025 Aug;14(4):1311-1329. doi: 10.1007/s40122-025-00745-3. Epub 2025 May 16.
PubMed 40377855
Guo X, Zhang T, Yuan G, Zeng W, Hu Q, Ma J, Li Y, Li H, Zhang Y, Liu J, Bian F, Zhang W, Zhang F, Pang S, Li Y, Wu X, Tang X, Zhang K, Pan T, Hu H, Cheng Z, Wang Y, Gao J, Sun J. GABA Analogue HSK16149 in Chinese Patients With Diabetic Peripheral Neuropathic Pain: A Phase 3 Randomized Clinical Trial. JAMA Netw Open. 2024 Aug 1;7(8):e2425614. doi: 10.1001/jamanetworkopen.2024.25614.
PubMed 39158916

Want to know more?

Fangqiong Li

+8602867258840

lifangq@haisco.com

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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A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Diabetic Peripheral Neuropathic Pain
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Comparative Effects of tDCS and tACS on Pain, Dexterity, and Strength in Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)
Active, not recruitingPhase 3
Evaluation of the Long-term Safety and Effectiveness of Suzetrigine (SUZ) in Participants With Painful Diabetic Peripheral Neuropathy (DPN)
Diabetic Peripheral Neuropathic Pain
Not yet recruitingPhase 2
Perineural Botulinum Toxin Injection Versus Oral Duloxetine in Relief of Foot Pain in Painful Peripheral Diabetic Neuropathy
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All Diabetic Peripheral Neuropathic Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo- and Pregabalin Capsule-Controlled, 13-Week, Adaptive-design Phase 2/3 Study to Evaluate the Efficacy and Safety of HSK16149 Capsules in Chinese Patients With Diabetic Peripheral Neuropathic Pain
ClinicalTrials.gov ID: NCT04647773
Acronym / sponsor ID: HSK16149-201/301
Conditions: Diabetic Peripheral Neuropathic Pain
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 687 participants (estimated)
Lead sponsor: Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
Study start: 2 Dec 2020 (estimated)
Primary completion: 9 Nov 2022 (estimated)
Study completion: 16 Nov 2022 (estimated)
First posted: 1 Dec 2020 (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 diabetic peripheral neuropathic pain (DPNP) following 13 weeks treatment in comparison to placebo.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
HSK16149 20mg BID	Experimental	Drug: HSK16149 20mg BID
HSK16149 40mg BID	Experimental	Drug: HSK16149 40mg BID
HSK16149 60mg BID	Experimental	Drug: HSK16149 60mg BID
HSK16149 80mg BID	Experimental	Drug: HSK16149 80mg BID
Pregabalin 150mg BID	Active comparator	Drug: Pregabalin 150mg BID
Placebo BID	Placebo comparator	Drug: Placebo BID

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Signed informed consent;
Males or females aged 18-75 years of age inclusive;
Diagnosis of diabetic peripheral neuropathic pain (DPNP) and diabetic peripheral neuropathy (DPN) pain ≥ 6 months;
HbA1c ≤ 9.0% at screening and on a stable antidiabetic medication regimen for at least 30 days prior to screening;
At Screening, pain scale (VAS) of ≥40 mm and <90 mm.

Key exclusion criteria (20 listed)

Peripheral neuropathy or pain unrelated to DPN that may confuse the assessment of DPNP.
Skin conditions in the area affected by neurupathy that could alter sensation.
Chronic systemic diseases that may affect subjects' participation in the study.
Severe hematologic, hepatic or renal dysfunction, the subject will be excluded if:
History of substance abuse or alcohol abuse.

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; 13-weeks fixed dose.	Drug	HSK16149 20mg BID
HSK16149 40mg BIDHSK16149 40mg, orally twice a day, treatment period; 13-weeks fixed dose.	Drug	HSK16149 40mg BID
HSK16149 60mg BIDHSK16149 60mg, orally twice a day, treatment period; 1-week titration and 12-weeks fixed dose.	Drug	HSK16149 60mg BID
HSK16149 80mg BIDHSK16149 80mg, orally twice a day, treatment period; 1-week titration and 12-weeks fixed dose.	Drug	HSK16149 80mg BID
Pregabalin 150mg BIDPregabalin 150mg, orally twice a day, treatment period; 1-week titration and 12-weeks fixed dose.	Drug	Pregabalin 150mg BID
Placebo BIDPlacebo, orally twice a day, treatment period; 13-weeks fixed dose.	Drug	Placebo BID

Primary outcome

Compare the change from baseline in Average Daily Pain Score（ADPS） between HSK16149 and placebo at week 5.
Time frame: Baseline and week 5
The mean change in average daily pain score (ADPS) was measured using a 11-point numeric rating scale (NRS; 0 [no pain] to 10 [worst possible pain]. The rating averaged over a 7-day period and was based on entries in patients' daily pain diaries.
Compare the change from baseline in Average Daily Pain Score （ADPS） between HSK16149 and placebo at week 13.
Time frame: Baseline and week 13
The mean change in average daily pain score (ADPS) was measured using a 11-point numeric rating scale (NRS; 0 [no pain] to 10 [worst possible pain]. The rating averaged over a 7-day period and was based on entries in patients' daily pain diaries.

11 secondary outcomes

Compare the response rate between HSK16149 and placebo at week 5 (Proportion of subjects whose ADPS decreased by ≥30% and ≥50% from baseline ).
Time frame: Baseline and week 5
AE, laboratory tests, physical and neurological examination, vital signs and 12-lead ECG to evaluate the safety of HSK16149 in 5 weeks post treatment.
Time frame: From week 1 to week 5
Compare the response rate between HSK16149 and placebo at week 13 (Proportion of subjects whose ADPS decreased by ≥30% and ≥50% from baseline ).
Time frame: Baseline and week 13
Compare the change from baseline in ADPS between HSK16149 and placebo at week 1 to 13.
Time frame: From week 1 to week 13
Compare the change from baseline in Visual Analog Scale （VAS） between HSK16149 and placebo at week 13.
Time frame: Baseline and week 13
Compare the change from baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) between HSK16149 and placebo at week 13.
Time frame: Baseline and week 13
Compare the Patient Global Impression of Change（PGIC） between HSK16149 and placebo at week 13.
Time frame: Week 13
Compare the change from baseline in Average Daily Sleep Interference score (ADSIS) between HSK16149 and placebo at week 13.
Time frame: Baseline and week 13
Compare the change from baseline in EuroQol-5-Domain-5-Level health questionnaire (EQ-5D-5L) between HSK16149 and placebo at week 13.
Time frame: Baseline and week 13
AE, laboratory tests, physical and neurological examination, vital signs and 12-lead ECG to evaluate the safety of HSK16149 during the trial.
Time frame: From week 1 to week 14
Pharmacokinetic (PK) characteristics of HSK16149 capsules in Chinese patients with diabetic peripheral neuropathic pain.
Time frame: Week 1,week 5,week 11,week 13

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2020.
Derived from this study: PubMed 40377855Pan T, Ma J, Li Y, Wang K, Jiang C, Zhang Y, Liu J, Du R, Zhang W, Bian F, Zhang F, Wang L, Pang S, Ning T, Wang B, Li Y, Wu X, Zhang K, Tang X, Hu H, Sun X, Li P, Cheng Z, Sun J, Yang J, Wang Y, Gao J, Mao H, Li F, Huang Q, Li Y, Peng Z, Guo X. Rapid Onset of Pain Relief with Crisugabalin in Patients with Diabetic Peripheral Neuropathic Pain: Findings from a Multicenter, Randomized, Double-Blind, Controlled Study. Pain Ther. 2025 Aug;14(4):1311-1329. doi: 10.1007/s40122-025-00745-3. Epub 2025 May 16.
Derived from this study: PubMed 39158916Guo X, Zhang T, Yuan G, Zeng W, Hu Q, Ma J, Li Y, Li H, Zhang Y, Liu J, Bian F, Zhang W, Zhang F, Pang S, Li Y, Wu X, Tang X, Zhang K, Pan T, Hu H, Cheng Z, Wang Y, Gao J, Sun J. GABA Analogue HSK16149 in Chinese Patients With Diabetic Peripheral Neuropathic Pain: A Phase 3 Randomized Clinical Trial. JAMA Netw Open. 2024 Aug 1;7(8):e2425614. doi: 10.1001/jamanetworkopen.2024.25614.
Individual participant dataSharing planned: No

Related trials for Diabetic Peripheral Neuropathic Pain

Recruiting
Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy
Diabetic Neuropathies, Diabetes Mellitus (Type 2)
RecruitingPhase 2
A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Diabetic Peripheral Neuropathic Pain
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Active, not recruiting
Comparative Effects of tDCS and tACS on Pain, Dexterity, and Strength in Diabetic Peripheral Neuropathy
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Active, not recruitingPhase 3
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Not yet recruitingPhase 2
Perineural Botulinum Toxin Injection Versus Oral Duloxetine in Relief of Foot Pain in Painful Peripheral Diabetic Neuropathy
Diabetic Peripheral Neuropathy, Painful Diabetic Neuropathy

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 contact

+8602867258840

lifangq@haisco.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 20 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: status not confirmed, as of the sponsor's last update on 1 Dec 2020. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Fangqiong Li (+8602867258840, lifangq@haisco.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compare the change from baseline in Average Daily Pain Score（ADPS） between HSK16149 and placebo at week 5. (time frame: Baseline and week 5). The study lists 2 primary outcomes in all. 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 NCT04647773, which also lists 2 linked publications.

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 1 Dec 2020.