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NCT05756595
A Clinical Study of Freshly Manufactured 35kDa Hyaluronan Fragment in the Treatment of Pain
NA trial testing HA35(L20200708MP07707, Ministry of Health, Mongolia) was freshly manufactured by mixing hyaluronidase PH20 injectable solution (H31022111) and high-molecular-weight HA injectable solution (H20174089) in Shoulder Pain in 36 participants. Completed in 8 February 2023.
29 December 2022
Quick facts
| Lead sponsor | Dove Medical Press Ltd |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 36 |
| Start date | 6 July 2020 |
| Primary completion | 29 December 2022 |
| Estimated completion | 8 February 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- HA35(L20200708MP07707, Ministry of Health, Mongolia) was freshly manufactured by mixing hyaluronidase PH20 injectable solution (H31022111) and high-molecular-weight HA injectable solution (H20174089)
Conditions studied
- Shoulder Pain — all drugs for Shoulder Pain →
- Neck Pain — all drugs for Neck Pain →
- Back Pain — all drugs for Back Pain →
- Temporal Pain — all drugs for Temporal Pain →
Sponsor
Dove Medical Press Ltd — full company profile →
Who can join
Adults 39 to 63, any sex, with Shoulder Pain or Neck Pain. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Local used high molecular weight Hyaluronan (HA) with high viscosity has a variety of receptors in the human body, including CD44, LYVE-1, RHAMM, HARE, Siglec-9, TLR2, CEMIP and TMEM2. Intra-articular local injection of HA has a certain degree of analgesic effect. Local injection of HA into the nerve trunk directed by ultrasound was used for the treatment of neuropathic pain. It was reported that the analgesic effect of HA is regulated by TRPV1 ion channels. This study hypothesizes that hyaluronidase cleaves HA to generate low molecular weight HA fragments HA35 with good tissue permeability, which may bind to a variety of HA receptors on the cell surface within the tissues and produce a broad-spectrum analgesic effect. In this study, 35kDa Hyaluronan fragment HA35 was prepared by mixing hyaluronidase PH20 injection and high molecular weight Hyaluronan (HA) injection at room temperature for 20 minutes. In this study, hyaluronidase injection and Hyaluronan injection were off-label used to conduct an investigator-initiated study (IIT or IIS) for the treatment of herpes zoster and shoulder, neck, back and temporal pain.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Characterization, Bioactivity, and Biodistribution of 35 kDa Hyaluronan Fragment.
Gantumur MA, Jia X, Hui JH, Barber C, et al · · 2024 · cited 9× · PMID 38255712 · DOI 10.3390/life14010097
Verify or expand the search:
- PubMed search for NCT05756595
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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Related trials
Other trials of HA35(L20200708MP07707, Ministry of Health, Mongolia) was freshly manufactured by mixing hyaluronidase PH20 injectable solution (H31022111) and high-molecular-weight HA injectable solution (H20174089)
Trials testing the same drug.
- NCT05765513 — HA35 Treatment the Gingival Discomfort as Well as Gingival Redness and Bleeding of Patients With Periodontitis · NA · completed
Other recruiting trials for Shoulder Pain
Currently open trials in the same condition.
- NCT07493226 — Efficacy of Chemically Distinct Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) and Pain Phenotypes in Adhesive Capsulitis · NA · recruiting
- NCT07493213 — USG-Guided Shoulder Injections in Frozen Shoulder · NA · recruiting
- NCT07424638 — Interscalene Block Versus Anterior Suprascapular Block for Post-Thoracotomy Shoulder Pain · NA · recruiting
- NCT07394673 — Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block for Analgesia in Arthroscopic Shoulder Surgery · NA · recruiting
- NCT07334171 — Inspiratory Muscle Strength and Diaphragm Thickness in People With Shoulder Pain in Tennis Players · active not recruiting
Other Dove Medical Press Ltd trials
Trials by the same sponsor.
- NCT05809700 — Injection Therapy for Neuropathic Pain · NA · completed
- NCT05812300 — Local Injection of Periodontal Pocket Method for the Treatment of Gingivitis · NA · completed
- NCT05765513 — HA35 Treatment the Gingival Discomfort as Well as Gingival Redness and Bleeding of Patients With Periodontitis · NA · completed
- NCT05766930 — The Novel Electrolyzed Water Spray Treatment the Genital Itching · NA · completed
- NCT05770258 — The Novel Electrolyzed Water Spray Treatment Mild Periodontitis · NA · completed
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 NCT05756595 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Dove Medical Press Ltd
- Last refreshed: 6 March 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/NCT05756595.
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