A Study to Validate a New Treatment in Patients with Chronic Pain Associated to Osteoarthritis.

Phase 1

• Conditions: Osteoarthritic pain of knee or hip.; MedDRA version: 20.0Level: LLTClassification code 10023476Term: Knee osteoarthritisSystem Organ Class: 100000004859; MedDRA version: 20.0Level: LLTClassification code 10020108Term: Hips osteoarthritisSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2017-001028-23-BE
• Lead Sponsor: Tools4Patient

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-06
• Last Update Posted: 24 September 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

• Men or women of at least 18 years of age.
• OA of knee or hip diagnosed since at least 6 months.
• Pain scores reported during the baseline period preceding randomization
with a mean APS on the last 14 reported values before Visit 2 between 3.6 and 8.4 inclusive and to have completed at least 2/3 of each pain score in their diary between Visit 1 and Visit 2.
• Patient with a unilateral or bilateral OA of the knee or hip diagnosed according to the American College of Rheumatology (ACR) criteria based on clinical and radiographic evidence (Altman et al., 1986) (in case of bilateral OA or OA of both knee and hip, the joint to consider should be the most affected one). The clinical diagnosis of OA will be confirmed by the ACR clinical criteria and medical imaging criteria for classification of OA of the knee or hip based upon the following criteria:
a. Knee or hip pain as an average at least half of the time for the last 3 months before screening visit.
b. OA of the knee, at least 1 of the following 3 conditions:
i. age > 50,
ii. morning stiffness <30 minutes,
iii. crepitus on active motion and osteophytes.
OA of the hip, at least 2 of the following 3 conditions:
i. erythrocyte sedimentation rate (ESR) < 20mm/hour,
ii. femoral and/or acetabular osteophytes,
iii. joint space narrowing (superior, axial, and/or medial).
c. Kellgren and Lawrence grade > 1 as assessed by a recent medical imaging of the referred joint to confirm the diagnosis. If no imaging available, a new anterior- posterior view will be obtained and reviewed by Investigator or his/her delegate(s) to verify that the patient meets the disease diagnostic criteria.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 38
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

• Change in the « regular analgesic therapy » or introduction of a « regular analgesic therapy » (if none beforehand) for OA in the last 4 weeks prior to Visit 1 or during the study.
• Invariable pain scores reported between Visit 1 and Visit 2.
• Pregnant, breastfeeding, or willing to be pregnant during the study.
• Patients with a current or recent history, as determined by the Investigator,
a. of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease;
b. any known hypersensitivity to corn and/or corn-derived products;
which would interfere with the patient's participation in the study.
• Any other relevant medical disorder/acute disease state/pain condition like fibromyalgia, lombalgia, generalized OA judged by the Investigator as likely to interfere with the trial or represent a risk for the patient.
• Having completed or withdrawn from this study or any study investigating T4P1001.
• Have planned total knee or hip replacement intervention of the referred joint.
• Reduced mobility due to OA (use of lower extremity assistive devices other than a cane or a knee sleeve such as crutches or walker or a knee brace or a shoe lift” in relation to OA is not allowed).
• Use or plan to use systemic corticosteroids 4 weeks prior to Visit 1 or during the study; Intra-muscular corticosteroid injections or Intra-articular injection of steroids into the referred knee/hip within 3 months before Visit 1 or during the study; Intra-articular injection of corticosteroids into any other sites than the referred knee/hip within 4 weeks prior to Visit 1 or during the study (corticosteroids in topical use are allowed).
• Have used viscosupplementation or intra articular injection of hyaluronic acid in the referred joint within 3 months prior to Visit 1 or plan to use during the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified