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

Primary Purpose

Osteoarthritis

Status
Recruiting
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Cilostazol 50 MG
Placebo
Sponsored by
Sadat City University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of PharmacyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cilostazol

Placebo

Arm Description

Cilostazol 50 mg twice daily plus Celecoxib 200mg capsule

Placebo tablet twice daily plus Celecoxib 200mg capsule

Outcomes

Primary Outcome Measures

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."

Secondary Outcome Measures

WOMAC change
the change of WOMAC Osteoarthritis Index from baseline to posttreatment
the change of Short Form 36 Questionnaire (SF-36) score from baseline to posttreatment
The SF-36 is a generic instrument to assess health-related quality of life. It consists of 36 questions and assesses 8 dimensions: physical functioning, role physical, pain index, general health, vitality, social functioning, role emotional, and mental health index. It also provides 2 summary measures of physical and mental components. The SF-36 score ranges from 0 to 100, with higher scores indicating better health status.
Adverse drug reaction
Clinical side effects
Interleukin 1 beta
Interleukin 1 beta serum level
Serum level Tumor necrosis factor- alpha (TNF-α)
Serum level Tumor necrosis factor- alpha (TNF-α)
Serum levels of IL-17
Serum levels of IL-17
Serum levels of BDNF
Serum levels of BDNF
Serum levels of IL-10
Serum levels of IL-10

Full Information

First Posted
March 6, 2021
Last Updated
July 28, 2022
Sponsor
Sadat City University
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1. Study Identification

Unique Protocol Identification Number
NCT04789837
Brief Title
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sadat City University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cilostazol
Arm Type
Experimental
Arm Description
Cilostazol 50 mg twice daily plus Celecoxib 200mg capsule
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablet twice daily plus Celecoxib 200mg capsule
Intervention Type
Drug
Intervention Name(s)
Cilostazol 50 MG
Intervention Description
Cilostazol 50 mg twice daily plus Celecoxib 200mg capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet twice daily plus Celecoxib 200mg capsule
Primary Outcome Measure Information:
Title
Visual Analogue scale assessment of pain
Description
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."
Time Frame
week 12
Secondary Outcome Measure Information:
Title
WOMAC change
Description
the change of WOMAC Osteoarthritis Index from baseline to posttreatment
Time Frame
week 12
Title
the change of Short Form 36 Questionnaire (SF-36) score from baseline to posttreatment
Description
The SF-36 is a generic instrument to assess health-related quality of life. It consists of 36 questions and assesses 8 dimensions: physical functioning, role physical, pain index, general health, vitality, social functioning, role emotional, and mental health index. It also provides 2 summary measures of physical and mental components. The SF-36 score ranges from 0 to 100, with higher scores indicating better health status.
Time Frame
week 12
Title
Adverse drug reaction
Description
Clinical side effects
Time Frame
12 weeks
Title
Interleukin 1 beta
Description
Interleukin 1 beta serum level
Time Frame
12 weeks
Title
Serum level Tumor necrosis factor- alpha (TNF-α)
Description
Serum level Tumor necrosis factor- alpha (TNF-α)
Time Frame
12 weeks
Title
Serum levels of IL-17
Description
Serum levels of IL-17
Time Frame
12 weeks
Title
Serum levels of BDNF
Description
Serum levels of BDNF
Time Frame
12 weeks
Title
Serum levels of IL-10
Description
Serum levels of IL-10
Time Frame
12 WEEKS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Faculty of Pharmacy
City
Shibīn Al Kawm
State/Province
Menoufia
ZIP/Postal Code
13829
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahmoud S Abdallah, PhD
Phone
01063340887
Email
Mahmoud.samy@fop.usc.edu.eg
Phone
+201063340887
Email
Mahmoud.samy@fop.usc.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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