NCT01288001

Brief Summary

A pilot, open, randomised, controlled, add-on study evaluating the duration of efficacy of one intra articular injection of sodium hyaluronate 2.0% in patients with painful osteoarthritis of the knee

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 2, 2011

Completed
27 days until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

November 21, 2012

Status Verified

November 1, 2012

Enrollment Period

9 months

First QC Date

January 31, 2011

Last Update Submit

November 20, 2012

Conditions

Osteoarthritis Patient

Outcome Measures

Primary Outcomes (1)

  • to evaluate the duration of efficacy of one intra articular injection of Ostenil® Plus in patients with painful osteoarthritis of the knee.

    WOMAC score

    6 months

Secondary Outcomes (1)

  • to evaluate the effects of the study treatment on pain, joint stiffness, joint function and need for analgesic consumption.

    6 months

Study Arms (1)

Ostenil plus

EXPERIMENTAL

Patient will get Ostenil plus injection and standard treatment of Osteoarthritis

Drug: Ostenil plus

Interventions

Ostenil plusDRUG

2% Sodium Hyaluronate plus Mannitol injection

Ostenil plus

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients of both genders between 40 and 70 years of age;
  • Primary tibiofemoral osteoarthritis of the knee according to American College of Rheumatology criteria;
  • Pain ≥ 4 on a 10 point scale for at least two out of five subscores of the WOMAC Section A at baseline;
  • Radiologically ascertained grade II or III severity knee osteoarthritis on the Kellgren-Lawrence scale;
  • Having given signed informed consent.

You may not qualify if:

  • Secondary knee osteoarthritis, including:
  • septic arthritis;
  • inflammatory joint disease;
  • gout;
  • recurrent episodes of pseudogout;
  • Paget's disease of bone;
  • articular fracture;
  • ochronosis;
  • acromegaly;
  • haemochromatosis;
  • Wilson's disease;
  • primary osteochondromatosis.
  • Clinical signs of acute flare (pain, warm, erythema, effusion of signal knee) at baseline;
  • Axial deviation \> 15 degrees in valgus or varus on a standing X-ray;
  • Clinically significant medio-lateral or antero-posterior instability;
  • +33 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siriraj Hospital

Bangkoknoi, Bangkok, 10700, Thailand

Location

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2011

First Posted

February 2, 2011

Study Start

March 1, 2011

Primary Completion

December 1, 2011

Study Completion

July 1, 2012

Last Updated

November 21, 2012

Record last verified: 2012-11

Locations

TH(1)