Last reviewed · How we verify
NCT04470128
A Study Evaluating the Efficacy and Safety of HSK21542 Injection for Analgesia in Subjects Undergoing Colonoscopy
Phase 2 trial testing Stage I: HSK21542 0.5 μg/kg in Analgesia in 180 participants. Completed in 30 January 2021.
28 December 2020
Quick facts
| Lead sponsor | Haisco Pharmaceutical Group Co., Ltd. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 180 |
| Start date | 19 August 2020 |
| Primary completion | 28 December 2020 |
| Estimated completion | 30 January 2021 |
| Sites | 1 location across China |
Drugs / interventions tested
- Stage I: HSK21542 0.5 μg/kg — full drug profile →
- Stage I: HSK21542 1 μg/kg — full drug profile →
- HSK21542 0.5 μg/kg — full drug profile →
- HSK21542 1 μg/kg — full drug profile →
- HSK21542 2 μg/kg — full drug profile →
- Placebo
Conditions studied
- Analgesia — all drugs for Analgesia →
Sponsor
Haisco Pharmaceutical Group Co., Ltd. — full company profile →
Who can join
Adults 18 to 75, any sex, with Analgesia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a multi-center, randomized, two-stage, phase II clinical study .The main objective is to evaluate the safety and tolerability of HSK21542 injection for analgesia in patients undergoing colonoscopy, and, combining the pharmacodynamic (PD) and pharmacokinetic (PK) characteristics
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04470128
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Analgesia
Currently open trials in the same condition.
- NCT07249827 — A Randomized Comparison Between 0.67 mcg/kg, 1 mcg/kg, and 1.33 mcg/kg of Perineural Dexmedetomidine for Ultrasound-Guid · Phase 2 · recruiting
- NCT07250230 — Effect of Perioperative High-dose Transdermal Nicotine Patch on Pain Sensitivity Among Male Abstinent Tobacco Smokers Un · NA · recruiting
- NCT07337629 — Single Dose Preemptive Paracetamol or Ibuprofen Before Septrorhinoplasty on Intra- and Postoperative Opioid Consumption. · recruiting
- NCT07310953 — Clinical Utility of the Numerical Verbal Scale (NVS) and the Pain and Functional Activity Scale (PFAS) in the Management · NA · recruiting
- NCT06869967 — Evaluation of Postoperative Pain Control in Ear Surgery · NA · recruiting
Other Haisco Pharmaceutical Group Co., Ltd. trials
Trials by the same sponsor.
- NCT07533786 — A Clinical Trial Evaluating the Efficacy and Safety of HSK55718 in Patients for Postoperative Pain Treatment in Abdomina · Phase 2 · not yet recruiting
- NCT07519070 — A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of HSK44 · Phase 3 · not yet recruiting
- NCT07503587 — Evaluating the Efficacy and Safety of of HSK44459 in People With Progressive Pulmonary Fibrosis · Phase 3 · not yet recruiting
- NCT07521345 — A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and the Food Effect of HSK55879 Tablets in Healt · Phase 1 · recruiting
- NCT07335055 — A Study for HSK47388 in Participants With Ulcerative Colitis · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04470128 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Haisco Pharmaceutical Group Co., Ltd.
- Last refreshed: 21 February 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04470128.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing