Clinical trial NCT04789837: The Phosphodiesterase 3 Inhibitor Cilostazol as an Adjunct to Conventional Therapy in Patients With Osteoarthritis
Official title: The Phosphodiesterase 3 Inhibitor Cilostazol as an Adjunct to Conventional Therapy in Patients With Osteoarthritis: A Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Osteoarthritis
Lead sponsor: Sadat City University
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 120
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cilostazol is able to suppress the degradation of type II collagen in human chondrocytes induced by IL-1b. Cilostazol add-on for celecoxib therapy has synergistic anti-arthritic potential by inhibiting proinflammatory cytokine production in synovial fibroblasts through the IL-10/SOCS3 pathways, consequently leading to the inhibition of synovial cell proliferation and overcoming the perpetuation of synovial inflammation.


Eligibility criteria: Inclusion Criteria:

* Primary osteoarthritis Patients recruited were between 30 to 60 years of age, with X-ray confirmed Kellgren-Lawrence grade13 II or III severity primary tibiofemoral OA, according to the American College of Rheumatology criteria.

Exclusion Criteria:

* Those patients were excluded from the present study who:

  * were of age less than 30 years or more than 60 years
  * presented with active concomitant gastroduodenal disorders, hepatic and renal impairment within last 30 days prior to receiving the study drug
  * were diagnosed to have any inflammatory arthritis, gout or acute trauma of the knee, hip or spine; accompanying OA of the hip of sufficient severity to interfere with the functional assessment of the knee
  * had previous or ongoing treatment with oral SYSDOA (e.g., glucosamine sulphate, chondroitin sulphate, diacerein, piascledine), anti-depressants, tranquillisers, antacids or antibiotics; were having active cardiac lesion or hypertension, were pregnant females and those who were planning their pregnancy during the study
  * were having a known hypersensitivity to the used medications
  * have persistent diarrhoea or laxative use; severe gastrointestinal disorders, severe obesity, severe parenchymal organ disease, or anaemia (haemoglobin\< 10.0 g/ dl or haematocrit \< 30%).
  * Patients who received oral, intramuscular, intraarticular or soft tissue injections of corticosteroids within last eight weeks before receiving the first dose of the study medication, or had undergone joint lavage and arthroscopic procedures in the previous 6 months, were also excluded.

Primary outcomes:
measure: Visual Analogue scale assessment of pain
timeFrame: week 12
Secondary outcomes:
measure: WOMAC change
timeFrame: week 12
measure: the change of Short Form 36 Questionnaire (SF-36) score from baseline to posttreatment
timeFrame: week 12
measure: Adverse drug reaction
timeFrame: 12 weeks
measure: Interleukin 1 beta
timeFrame: 12 weeks
measure: Serum level Tumor necrosis factor- alpha (TNF-α)
timeFrame: 12 weeks
measure: Serum levels of IL-17
timeFrame: 12 weeks
measure: Serum levels of BDNF
timeFrame: 12 weeks
measure: Serum levels of IL-10
timeFrame: 12 WEEKS
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: Faculty of Pharmacy
state: Menoufia
Study officials:
References: