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Gel-One Treatment in Knee Osteoarthritis

S

Seikagaku

Status

Completed

Conditions

Osteoarthritis Knee

Treatments

Device: PBS
Device: Gel-One

Study type

Interventional

Funder types

Industry

Identifiers

NCT01934218
Gel/1133

Details and patient eligibility

About

The purpose of this study is to determine whether Gel-One demonstrates a superior effectiveness in osteoarthritis (OA) knee pain compared with phosphate buffered saline (PBS) injections.

Enrollment

814 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Have a knee pain
  • Grade 1 to 3 on the Kellgren-Lawrence grading scale

Exclusion criteria

  • BMI greater than 35 kg/m2
  • Received an intra-articular hyaluronic acid injection for the treatment of OA of the knee within 6 months prior to screening
  • Had a joint replacement of the target knee

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

814 participants in 2 patient groups, including a placebo group

Gel-One
Active Comparator group
Description:
3 mL, a single intra-articular injection of Gel-One
Treatment:
Device: Gel-One
Phosphate Buffered Saline (PBS)
Placebo Comparator group
Description:
3 mL, a single intra-articular injection of PBS
Treatment:
Device: PBS

Trial contacts and locations

41

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Data sourced from clinicaltrials.gov

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