Patient Walking Rehabilitation Program with osteoarthritis of the hip or knee helped by a one-off anti-inflammatory treatment (pilot cohort study with short walking objectives) - PERIPATEI

Overview

Sponsor-declared trial summary

Key facts

Sponsor

University Hospital Of Clermont-Ferrand

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]

Trial duration

7 Nov 2023 → ongoing

Decision date (initial)

2023-01-18

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

Study the efficacy and tolerance of the reasoned and punctual intake of a non-steroidal anti-inflammatory drug (NSAID), as part of a walking rehabilitation program for patients suffering from osteoarthritis of the hip or knee.

Secondary objectives 4

1. Study compliance with the program and its possible determinants.
2. Identify the therapeutic programs (1 program = 1 NSAID molecule in a particular field) most suspected of adverse effects.
3. ­ Identifier les déterminants de la réussite du programme thérapeutique, parmi un ensemble de critères démographiques ou psychométriques mesurés en début d’étude.
4. study the influence of central sensitization (explored by temporal summation) on the efficacy of NSAID treatment during the walking test and during the program.

Conditions and MedDRA coding

Idiopathic osteoarthritis of the hip or knee

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Patient, man or woman aged 50 to 70, suffering from uni- or bilateral idiopathic osteoarthritis of the hip or knee, whose diagnosis is confirmed by compliance with the radio-clinical criteria of the American College of Rheumatology (Altman et al., 1986): Joint pain felt for at least half the time during the last 3 months prior to inclusion /Morning stiffness lasting less than 30 minutes or joint crackling / Kellgren and Lawrence stage ≥ 2 attested by an available x-ray
2. Walking pain rated at least 4 on a scale of 0 (no pain) to 10 (worst imaginable pain), associated with consequent limitation of walking ability (declarative)
3. Weekly number of significant trips (walking of at least 20 minutes or 1000 meters) < 3
4. Ability to comply with protocol requirements and provide informed consent to participate in research
5. Comprehension and fluent writing of the French language
6. Coverage by a Social Security scheme

Exclusion criteria 41

1. ­Pregnant or breastfeeding woman
2. Person under guardianship, curatorship or safeguard of justice, or deprived of freedoms
3. ­Weight < 40 kg or body mass index (BMI) < 19 kg.m–2
4. ­Weight > 130 kg or body mass index (BMI) > 35 kg.m–2
5. ­Ambulation not possible
6. ­Use of walking aids other than: cane, crutch, orthosis, knee brace
7. ­Introduction during the month preceding the inclusion of a new analgesic treatment, pharmacological or not
8. ­Concomitant topical NSAID treatment (can be suspended for the duration of the study)
9. ­ Provision during the period of the initiation study of a pharmacological analgesic treatment different from that proposed by the protocol, including systemic corticosteroid
10. ­Forecast during the period of the initiation study of a non-pharmacological analgesic treatment different from that proposed by the protocol, such as physiotherapy, behavioral therapy (self-management of pain, hypnosis, sophrology, meditation, mindfulness)
11. ­ Use of a unicompartmental unloading hinged orthosis (indicated for pain predominant in a femoro-tibial compartment of the knee) initiated during the 2 months preceding inclusion, or scheduled during the study period (continuation of older use is possible)
12. ­Intra-articular injection of glucocorticoid into the affected joint(s), during the 2 months preceding inclusion, or scheduled during the study period.
13. ­Visco-supplementation in one or more joints concerned, during the 2 months preceding inclusion, or scheduled during the study period
14. ­Intramuscular injection of glucocorticoid during the month preceding inclusion
15. ­Interventional surgery on one or more joints concerned, in the 6 months preceding the scheduled inclusion during the study period
16. ­Arthroscopy of one or more joints concerned, within 3 months prior to inclusion or scheduled during the study period
17. Other major surgery scheduled during the study period
18. ­Possible progressive hematological or cancerous pathology (with the exception of a basal cell carcinoma for which total excision was recently performed)
19. ­Immunodepression
20. ­Causal pathology of the suspected or proven arthropathy, such as: inflammatory rheumatism, septic arthritis, recent osteonecrosis, hemochromatosis, Wilson's disease, gout, acromegaly
21. ­Other general osteo-articular pathology such as Paget's or Reiter's disease
22. ­Chronic pain (especially neuropathic) concomitant with joint pain, considered severe enough to be an obstacle to walking
23. ­Hypersensitivity to one of the excipients of a treatment provided for in the protocol, which cannot be replaced by an equivalent formulation
24. ­ History of hypersensitivity reactions such as: angioedema, asthma, bronchospasm, nasal polyps, rhinitis, urticaria, or other allergic reactions triggered by taking NSAIDs or acetylsalicylic acid
25. ­History of haemorrhage or gastrointestinal perforation during previous treatment with NSAIDs
26. Active peptic ulcer, history of peptic ulcer or recurrent bleeding (2 or more distinct episodes of documented bleeding or ulceration).
27. Severe hepatocellular insufficiency, or liver transplantation, or plasma levels of hepatic transaminases exceeding two and a half times the upper limit of normal according to laboratory standards
28. Renal impairment defined by an estimated creatinine clearance < 60 mL/min (MDRD) or renal transplantation, or serum creatinine exceeding one and a half times the upper limit of the normal according to laboratory standards
29. Uncontrolled high blood pressure
30. Congestive heart failure (EF < 40%)
31. Insulin-requiring diabetes
32. Known bleeding disorder
33. Alcohol dependence or known drug use (e.g. non-prescription opioids, amphetamines, cannabis, cocaine, phencyclidine, etc.).
34. Regular intake of strong or substitute opioids (occasional intake of a strong opioid, or regular intake of tramadol or a weak opioid and paracetamol combination is possible).
35. Hypersensitivity to paracetamol
36. Hypersensitivity to proton pump inhibitors, if protocol-specified clinical conditions indicate such treatment
37. According to the NSAID indicated by the clinical conditions provided for in the protocol: ibuprofen: evolving haemorrhage / diclofenac: ischemic heart disease, peripheral arterial disease and/or history of cerebrovascular accident (including transient ischemic attack)
38. Regular concomitant treatment with NSAIDs (taking an anti-aggregating dose of aspirin is possible and will influence the patient's risk classification)
39. Concomitant treatment that cannot be suspended during the trial: any agent known to be nephrotoxic / acetylsalicylic acid at anti-inflammatory doses (≥ 1g/dose and/or ≥ 3g/d), and at analgesic or antipyretic doses (≥ 500mg/dose and/or < 3g/d) / anticoagulant (AVK or AOD) / lithium / methotrexate, pemetrexed / ciclosporin, tacrolimus / tenofovir, disoproxil / glucocorticoid / deferasirox / pentoxifylline / potassium-sparing diuretics, potassium / According to the NSAID indicated by the clinical conditions provided for in the protocol : ketoprofen: cardiac glycosides, nicorandil ; diclofenac: digoxin, cytochrome CYP2C9 inhibitors, phenytoin, quinolones
40. Participation in another clinical trial, or in a period of exclusion from another clinical trial
41. Presence of any medical condition deemed incompatible with the study by the investigator

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. For a given individual, the main criterion is the success of the therapeutic program, defined by an increase of at least 30% in the monthly number of target movements compared to the month of basal observation, in the absence of treatment discontinuation. NSAIDs for intolerance

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 6

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

University Hospital Of Clermont-Ferrand

Sponsor organisation

University Hospital Of Clermont-Ferrand

Address

58 Rue Montalembert

City

Clermont Ferrand Cedex 1

Postcode

63003

Country

France

Scientific contact point

Organisation

University Hospital Of Clermont-Ferrand

Contact name

Lise Laclautre

Public contact point

Organisation

University Hospital Of Clermont-Ferrand

Contact name

Lise Laclautre

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 50 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications