NCT02830919

Brief Summary

This phase III clinical study will be conducted in Brazilian research sites. It will be included in the study 314 participants diagnosed with primary knee OA according to the classification criteria of the ACR. After a washout period, the participants will be randomized to receive the combination of glucosamine sulfate + chondroitin sulfate of bovine origin of Eurofarma Laboratorios S.A. (N= 157) or the combination of glucosamine sulfate + chondroitin sulfate of Zodiac Pharmaceuticals S.A. Condroflex ® (N = 157). The treatment period of the study will be of 24 weeks. Each participant will perform seven visits to the research site. The main evaluations will be the improve of pain in the target knee by questionnaire Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and quality of life by SF-12 questionnaire.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
627

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

4 active sites

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

July 7, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 13, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

December 5, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2019

Completed
Last Updated

October 9, 2019

Status Verified

October 1, 2019

Enrollment Period

2.4 years

First QC Date

July 7, 2016

Last Update Submit

October 8, 2019

Conditions

Osteoarthritis of Knee

Keywords

Osteoarthritis of kneeGlucosamine sulfateChondroitin sulfate

Outcome Measures

Primary Outcomes (1)

  • Absolute change of pain WOMAC subscale score 24 weeks after initiation of treatment.

    24 weeks

Secondary Outcomes (4)

  • Absolute change the overall assessment of the disease by the investigator along treatment as measured by Visual Analog Scale from 0 to 100mm.

    24 weeks

  • Absolute change score of physical and mental components of the questionnaire SF-12 24 weeks after initiation of treatment compared to baseline.

    24 weeks

  • Incidence and profile of adverse events coded as MedDRA by treatment group.

    24 weeks

  • Frequency of treatment discontinuation for adverse events and laboratory abnormalities.

    24 weeks

Study Arms (2)

Glucosamine and chondroitin sulfate combination (Eurofarma)

EXPERIMENTAL

Glucosamine sulfate 1500mg plus chondroitin sulfate 1200mg combination, manufactured by Eurofarma Laboratórios S.A., administered once a day for 24 weeks.

Drug: Glucosamine and chondroitin sulfate combination (Eurofarma)

Glucosamine and chondroitin sulfate combination (Zodiac)

ACTIVE COMPARATOR

Glucosamine sulfate 1500mg plus chondroitin sulfate 1200mg combination, manufactured by Zodiac Produtos Farmacêuticos S.A. (Condroflex®), administered once a day for 24 weeks.

Drug: Glucosamine and chondroitin sulfate combination (Zodic)

Interventions

Glucosamine and chondroitin sulfate combination (Eurofarma)DRUG
Glucosamine and chondroitin sulfate combination (Eurofarma)
Glucosamine and chondroitin sulfate combination (Zodic)DRUG
Glucosamine and chondroitin sulfate combination (Zodiac)

Eligibility Criteria

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

You may qualify if:

  • Male and female patients meeting all the following criteria will be enrolled in the study:
  • Aged ≥ 40 years.
  • Clinical and radiological diagnosis of primary (idiopathic) arthrosis of knee according to the criteria of the American College of Rheumatology (ACR).
  • Kellgren and Lawrence radiological classification of degree 2 or 3 in x-ray of knee-target obtained in 3 months prior to the screening visit of the study.
  • Presence of painful symptoms in the target knee in the last 3 months due to osteoarthritis.
  • Visual analogue scale for evaluation of the pain of osteoarthritis of knee by the research participant in the screening visit ≥ 40 mm
  • Average score ≥ 40 mm in the subscale of "pain" (from 0 to 100 mm) in the target knee of the questionnaire Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), in the randomization visit.
  • Functional class ACR from I to III.
  • Signing the Informed Consent Form (ICF) before the performance of any study procedure.

You may not qualify if:

  • Patients meeting at least one of the following criteria will be excluded from the study:
  • Diagnosis of septic arthritis, inflammatory arthritis (as rheumatoid arthritis), gout, pseudogout, Paget's disease, dysplasias or congenital joint abnormalities.
  • Presence of inflammatory signals (edema, erythema or joint effusion) in the target knee, considered to be clinically significant by investigator.
  • Serious target knee joint misalignment, defined by investigator.
  • Predominantly patellofemoral Osteoarthritis in the target knee.
  • Historical of severe trauma or surgery (including arthroscopy) in the target knee in the 6 months before the screening visit.
  • Planned Surgery to the target knee
  • Symptomatic Osteoarthritis of the ipsilateral hip.
  • Use of non-steroidal anti-inflammatory, dipyrone and opioid analgesics or narcotics from the screening visit, or a washout period for these medicines less than those defined by the Protocol, before the randomization visit .
  • Oral Glucocorticoids, intravenously or intramuscularly in the 30 days prior to the screening visit.
  • Intraarticular corticosteroid Injection and/or hyaluronic acid in the target knee in 6 months prior to the screening visit.
  • Use of the following drugs in the periods described below, before the screening visit:
  • Diacerein, chloroquine or soybean and avocado unsaponifiables extracts in the last 3 months.
  • Duloxetine hydrochloride in the last 30 days.
  • Glucosamine Sulphate and/or chondroitin sulfate in the last 6 months.
  • +18 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Goiânia, Goiás, Brazil

Location

Unknown Facility

Curitiba, Paraná, Brazil

Location

Unknown Facility

Maringá, Paraná, Brazil

Location

Unknown Facility

São Paulo, São Paulo, Brazil

Location

Related Publications (1)

  • Lomonte ABV, Gimenez E, da Silva AC, Radominski SC, Scheinberg MA, Ximenes AC, de Freitas Zerbini CA. Treatment of knee osteoarthritis with a new formulation of a fixed-dose combination of glucosamine sulfate and bovine chondroitin: a multicenter, randomized, single-blind, non-inferiority clinical trial. Adv Rheumatol. 2021 Jan 19;61(1):7. doi: 10.1186/s42358-021-00165-9.

    PMID: 33468249DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Glucosamine

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

HexosaminesAmino SugarsCarbohydrates

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2016

First Posted

July 13, 2016

Study Start

December 5, 2016

Primary Completion

May 10, 2019

Study Completion

May 10, 2019

Last Updated

October 9, 2019

Record last verified: 2019-10

Locations

BR(4)