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A Clinical Study of Freshly Manufactured 35kDa Hyaluronan Fragment in the Treatment of Pain

NCT05756595 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-03-06

No results posted yet for this study

Summary

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.

Conditions

  • Shoulder Pain
  • Neck Pain
  • Back Pain
  • Temporal Pain
  • Herpes Zoster Pain

Interventions

DRUG

HA35(L20200708MP07707, Ministry of Health, Mongolia) was freshly manufactured by mixing hyaluronidase PH20 injectable solution (H31022111) and high-molecular-weight HA injectable solution (H20174089)

This group will inject once a week. Evaluation of pain score after 30 seconds and 3 hours.

Sponsors & Collaborators

  • The Affiliated Hospital of Qingdao University

    collaborator OTHER

  • Nakhia Impex LLC

    collaborator INDUSTRY

  • Dove Medical Press Ltd

    lead NETWORK

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
39 Years
Max Age
63 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-06
Primary Completion
2022-12-29
Completion
2023-02-08

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05756595 on ClinicalTrials.gov