NCT00977444

Brief Summary

Abstract Kondrium, is a pharmaceutical composition for the treatment of osteoarthritis (OA). This study was designed to evaluate the efficacy and safety of kondrium in the treatment of OA of knee. A 3 month, randomized, double-blind, active-controlled, parallel-group study will be carried out. 117 patients with OA of the knee will be randomized to receive 1 intra-articular monthly injection of 5 mL of one of the following: 75 mg/mL of Kondrium, 82.5 mg/mL of Kondriumf or 8 mg/mL of methylprednisolone once a month during 3 months. The primary efficacy variable will be the change from baseline to final assessment in the Western Ontario and McMaster University OA index (WOMAC subscale score for pain), and Lequesne´s functional index.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
114

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2007

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 15, 2009

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

January 20, 2010

Status Verified

January 1, 2010

Enrollment Period

1.3 years

First QC Date

September 11, 2009

Last Update Submit

January 19, 2010

Conditions

Osteoarthritis

Keywords

kneeosteoarthritis

Outcome Measures

Primary Outcomes (1)

  • The primary efficacy variable is the change from baseline to final assessment in the Western Ontario and McMastern University OA index (WOMAC), and Lequesne´s functional index.

    4 months

Study Arms (3)

kondrium

EXPERIMENTAL

intraarticular injections once month

Drug: kondrium

kondrium f

EXPERIMENTAL
Drug: kondrium f

corticosteroid

ACTIVE COMPARATOR

intraarticular injections once month

Drug: methyl prednisolone (corticosteroid)

Interventions

kondriumDRUG

intraarticular injections once month

kondrium
kondrium fDRUG

intraarticular injections once month

kondrium f
methyl prednisolone (corticosteroid)DRUG

intraarticular injections once month

Also known as: corticosteroid
corticosteroid

Eligibility Criteria

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

You may qualify if:

  • age \> 40 years
  • symptomatic evidence of OA in the knee for at least 1 year
  • radiographic evidence of Kellgren and Lawrence grade II to IV OA of the knee
  • no intra-articular injection of corticosteroids within the last 3 months

You may not qualify if:

  • any history of adverse reaction to the study drugs
  • current pregnancy status
  • uncontrolled hypertension
  • active infection
  • undergone surgery/arthroscopy within three months
  • diagnosis of radiographic OA of Kellgren and Lawrence grade I

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital San Jose

Querétaro City, Querétaro, Mexico

Location

Related Publications (2)

  • Caamano MDC, Garcia-Padilla S, Duarte-Vazquez MA, Gonzalez-Romero KE, Rosado JL. A Double-Blind, Active-Controlled Clinical Trial of Sodium Bicarbonate and Calcium Gluconate in the Treatment of Bilateral Osteoarthritis of the Knee. Clin Med Insights Arthritis Musculoskelet Disord. 2017 Feb 16;10:1179544116688899. doi: 10.1177/1179544116688899. eCollection 2017.

    PMID: 28469486DERIVED

  • Garcia-Padilla S, Duarte-Vazquez MA, Gonzalez-Romero KE, Caamano Mdel C, Rosado JL. Effectiveness of intra-articular injections of sodium bicarbonate and calcium gluconate in the treatment of osteoarthritis of the knee: a randomized double-blind clinical trial. BMC Musculoskelet Disord. 2015 May 13;16:114. doi: 10.1186/s12891-015-0568-4.

    PMID: 25963758DERIVED

MeSH Terms

Conditions

Osteoarthritis

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

HormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Ricardo Amador, PhD

    Hospital San Jose

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 11, 2009

First Posted

September 15, 2009

Study Start

November 1, 2007

Primary Completion

February 1, 2009

Study Completion

October 1, 2009

Last Updated

January 20, 2010

Record last verified: 2010-01

Locations

ME(1)