NCT00726245

Brief Summary

the improvement of symptoms and disease progress by the treatment of OA of the knee with PRGF

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2008

Typical duration 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

Study Start

First participant enrolled

January 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 31, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

July 12, 2011

Status Verified

July 1, 2011

Enrollment Period

1.1 years

First QC Date

July 29, 2008

Last Update Submit

July 10, 2011

Conditions

Muscle Tear

Outcome Measures

Primary Outcomes (1)

  • improvement of symptoms / disease progress

    1 year

Study Arms (2)

1

EXPERIMENTAL

PRGF

Biological: PRGF

2

PLACEBO COMPARATOR

physiological saline

Biological: Placebo

Interventions

PRGFBIOLOGICAL

3-6mg IM (to area of muscle tear)

1
PlaceboBIOLOGICAL

3cc IM of physiological saline

2

Eligibility Criteria

Age15 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • US diagnosed muscle tear
  • age 15-40 years old

You may not qualify if:

  • pregnancy
  • mental or physical disabilities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medicak Center

Kfar Saba, Israel

Location

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 29, 2008

First Posted

July 31, 2008

Study Start

January 1, 2008

Primary Completion

February 1, 2009

Study Completion

March 1, 2011

Last Updated

July 12, 2011

Record last verified: 2011-07

Locations

IL(1)