Management of Joint Pain Associated With Osteoarthritis o... | NCT02977936

Studies
Management of Joint Pain Associated With Osteoarthritis of the Knee With Association of Plant Extracts.

NCT02977936

Sponsor

PiLeJe

Status

Completed

Last Update Posted

Sep 29, 2020Actual

Enrollment

126Actual

Phase

Not provided

Conditions

Gonarthrosis

Interventions

Cartimotil Fort

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 12, 2017Actual

Primary Completion Date

May 14, 2019Actual

Completion Date

Sep 5, 2019Actual

First Submitted Date

Nov 25, 2016

First Submission Date that Met QC Criteria

Nov 25, 2016

First Posted Date

Nov 30, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 28, 2020

Last Update Posted Date

Sep 29, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of the study is to evaluate at 3 months the effect of a supplementation with extracts of Curcuma longa, Boswellia serrata and Porphyra umbilicalis on the acceptability of pain for patients suffering from gonarthritic pain.

Detailed Description

For this study, 126 patients are going to be included. They will have a supplementation of Cartimotil Fort®, from 1 to 4 capsules per day during 90 days.

on the one hand, during the two visits (inclusion and follow-up), the investigator completes the questionnaire about neuropathic pain (DN4).

on the other hand, patients complete the Osteoarthritis Symptom Inventory Scale (OASIS) 4 times : just after the inclusion visit, at day 30, at day 60 and just before the follow-up visit (day 90). He completes the Patient Global Impression of Improvement (PGII), the Minimal Clinically Important Improvement (MCII) and the Acceptable Symptomatic Statement (PASS) 6 times : just after the inclusion visit, at day 10, at day 20, at day 30, at day 60 and just before the follow-up visit (day 90).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

126Actual

Name	Type	Description	Arm Group Labels	Other Names
Cartimotil Fort	Dietary Supplement	1 to 4 capsules per day during 90 days

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of patients reaching the acceptability threshold of their state	Percentage of patients reaching the acceptability threshold of their state between D0 and D30 measured by the binary response of the PASS (yes = acceptable).	day 30

Secondary Outcomes

Measure	Description	Time Frame
OASIS Score		Day 30
OASIS Score		Day 60
OASIS Score

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

VAS of pain : minimum 5/10 on walking or 4/10 at rest
Patients with a negative PASS (patient considering that the symptomatic state is not acceptable)
Suffering from mono or bilateral femoro-tibial knee osteoarthrosis with painful seizures (confirmed by a radio of less than two years: stage 2 or 3 on the Kellgreen scale - clinical examination)
Having agreed to participate in the investigation after receiving information from the investigator

Exclusion Criteria:

Patients with rheumatological disorders other than osteoarthritis
Patients for whom knee surgery is planned within 3 months
Patients who started treatment with chondroitin sulphate (or all treatments of osteoarthritis other than anti-inflammatories and analgesics) for less than one month
Patients with a BMI greater than 35
Patients with chronic pain that can interfere with knee osteoarthritis pain
Patients with reduced mobility or bedridden
Patients with cognitive impairments not able to participate in the study
Patients with known allergies to any of the ingredients of Cartimotil Fort®
Pregnant or breastfeeding patients
Patients who do not wish to participate in the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients suffering from gonarthrosic pain

Sampling Method

Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36602324	Derived	Perrot S, Trouvin AP, Bouhassira D. Three dimensions of pain in osteoarthritis: development and validation of the Osteoarthritis Symptom Inventory Scale. Pain. 2023 Jul 1;164(7):1566-1577. doi: 10.1097/j.pain.0000000000002856. Epub 2023 Mar 22.

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases