Trial · NCT04647773
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| 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. |
| Secondary | Compare the change from baseline in EuroQol-5-Domain-5-Level health questionnaire (EQ-5D-5L) between HSK16149 and placebo at week 13. | Baseline and week 13 | The change from baseline in total EuroQol-5-Domain-5-Level health questionnaire. |
| Secondary | AE, laboratory tests, physical and neurological examination, vital signs and 12-lead ECG to evaluate the safety of HSK16149 during the trial. | From week 1 to week 14 | Number and severity of AEs, clinical laboratory abnormalities, physical examinations, 12-lead electrocardiograms (ECGs), and vital signs. |
| Secondary | Pharmacokinetic (PK) characteristics of HSK16149 capsules in Chinese patients with diabetic peripheral neuropathic pain. | Week 1,week 5,week 11,week 13 | Pharmacokinetics will be determined by measuring serum concentration of HSK16149. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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.
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