Trial · NCT04647773
To Evaluate the Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Diabetic Peripheral Neuropathic Pain
NCT04647773, Phase 2, Phase 3, Unknown, Haisco Pharmaceutical Group Co., Ltd.
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. To Evaluate the Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Diabetic Peripheral Neuropathic Pain. Trials, record NCT04647773. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04647773
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- To Evaluate the Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Diabetic Peripheral Neuropathic Pain
- NCT number
- NCT04647773
- Status
- Unknown
- Phases
- Phase 2, Phase 3
- Enrollment
- 687 participants, estimated
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Conditions
- Diabetic Peripheral Neuropathic Pain
- Interventions
- HSK16149 20mg BID, HSK16149 40mg BID, HSK16149 60mg BID, HSK16149 80mg BID, Pregabalin 150mg BID, Placebo BID
- First posted
- 2020-12-01
- Last updated
- 2020-12-01
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Compare the change from baseline in Average Daily Pain Score（ADPS） between HSK16149 and placebo at week 5. | 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. |
| Primary | Compare the change from baseline in Average Daily Pain Score （ADPS） between HSK16149 and placebo at week 13. | 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. |
| Secondary | Compare the response rate between HSK16149 and placebo at week 5 (Proportion of subjects whose ADPS decreased by ≥30% and ≥50% from baseline ). | Baseline and week 5 | 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. |
| Secondary | AE, laboratory tests, physical and neurological examination, vital signs and 12-lead ECG to evaluate the safety of HSK16149 in 5 weeks post treatment. | From week 1 to week 5 | Number and severity of AEs, clinical laboratory abnormalities, physical examinations, 12-lead electrocardiograms (ECGs), and vital signs. |
| Secondary | Compare the response rate between HSK16149 and placebo at week 13 (Proportion of subjects whose ADPS decreased by ≥30% and ≥50% from baseline ). | Baseline and week 13 | 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. |
| Secondary | Compare the change from baseline in ADPS between HSK16149 and placebo at week 1 to 13. | From week 1 to 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. |
| Secondary | Compare the change from baseline in Visual Analog Scale （VAS） between HSK16149 and placebo at week 13. | Baseline and 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. |
| Secondary | Compare the change from baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) between HSK16149 and placebo at week 13. | Baseline and 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) |
| Secondary | Compare the Patient Global Impression of Change（PGIC） between HSK16149 and placebo at week 13. | Week 13 | Patient global impression of change (PGIC) on a 7-point categorical scale, where 1 = very much improved and 7 = very much worse. |
| Secondary | Compare the change from baseline in Average Daily Sleep Interference score (ADSIS) between HSK16149 and placebo at week 13. | Baseline and 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. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04647773
GET https://conductscience.org/api/trials/v1/NCT04647773/registered