The Phosphodiesterase 3 Inhibitor Cilostazol as an Adjunct to Conventional Therapy in Patients With Osteoarthritis

NCT04789837 | Withdrawn Phase 1 DMC

• 1 other identifier: 15/2021RHU
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Visual Analogue scale assessment of pain

  the change of Visual Analogue Scale (VAS) pain score from baseline to posttreatment. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."

  week 12

Secondary Outcomes (8)

• WOMAC change

  week 12

• the change of Short Form 36 Questionnaire (SF-36) score from baseline to posttreatment

  week 12

• Adverse drug reaction

  12 weeks

• Interleukin 1 beta

  12 weeks

• Serum level Tumor necrosis factor- alpha (TNF-α)

  12 weeks

Study Arms (2)

Cilostazol

EXPERIMENTAL

Cilostazol 50 mg twice daily plus Celecoxib 200mg capsule

Drug: Cilostazol 50 MG

Placebo

PLACEBO COMPARATOR

Placebo tablet twice daily plus Celecoxib 200mg capsule

Drug: Placebo

Interventions

Cilostazol 50 MG DRUG

Cilostazol 50 mg twice daily plus Celecoxib 200mg capsule

Cilostazol

Placebo DRUG

Placebo tablet twice daily plus Celecoxib 200mg capsule

Placebo

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sadat City University: lead

Study Sites (1)

Faculty of Pharmacy

Shibīn al Kawm, Menoufia, 13829, Egypt

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Cilostazol

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: March 6, 2021
• First Posted: March 10, 2021
• Study Start: March 1, 2021
• Primary Completion: December 30, 2024
• Study Completion: December 31, 2024
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

EG (1)