OsteoarthritisPhase 1/2NCT04789837
The Phosphodiesterase 3 Inhibitor Cilostazol as an Adjunct to Conventional Therapy in Patients With Osteoarthritis
A Phase 1/2 study testing Cilostazol 50 MG in people with Osteoarthritis, run by Sadat City University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Cilostazol 50 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2021to 31 Dec 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Cilostazol 50 MG, Placebo
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cilostazol 50 MGDrug
Cilostazol 50 mg twice daily plus Celecoxib 200mg capsule
PlaceboDrug
Placebo tablet twice daily plus Celecoxib 200mg capsule
| Study group | Role | What they receive |
|---|---|---|
| Cilostazol | Experimental | Cilostazol 50 mg twice daily plus Celecoxib 200mg capsule Receives: Drug: Cilostazol 50 MG |
| Placebo | Placebo comparator | Placebo tablet twice daily plus Celecoxib 200mg capsule Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: week 12
Secondary outcomes (8)
WOMAC change
the change of WOMAC Osteoarthritis Index from baseline to posttreatment
Measured: week 12
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.
Measured: week 12
Adverse drug reaction
Clinical side effects
Measured: 12 weeks
Interleukin 1 beta
Interleukin 1 beta serum level
Measured: 12 weeks
Serum level Tumor necrosis factor- alpha (TNF-α)
Serum level Tumor necrosis factor- alpha (TNF-α)
Measured: 12 weeks
Serum levels of IL-17
Serum levels of IL-17
Measured: 12 weeks
Serum levels of BDNF
Serum levels of BDNF
Measured: 12 weeks
Serum levels of IL-10
Serum levels of IL-10
Measured: 12 WEEKS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start1 Mar 2021
- Primary completion30 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Why it stopped: Institutional and funding constrains
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sadat City University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Samy Abdallah, Sadat City University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04789837
- Sponsor's protocol ID
- 15/2021RHU
- Status last verified
- Jul 2025
- First submitted
- 6 Mar 2021
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04789837
- Acronym / sponsor ID
- 15/2021RHU
- Conditions
- Osteoarthritis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Institutional and funding constrains
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sadat City UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cilostazol | Experimental | Drug: Cilostazol 50 MGCilostazol 50 mg twice daily plus Celecoxib 200mg capsule |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablet twice daily plus Celecoxib 200mg capsule |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (8 listed)
- Those patients were excluded from the present study who:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cilostazol 50 MGCilostazol 50 mg twice daily plus Celecoxib 200mg capsule | Drug | Cilostazol |
| PlaceboPlacebo tablet twice daily plus Celecoxib 200mg capsule | Drug | Placebo |
Primary outcome
Visual Analogue scale assessment of pain
Time frame: week 12
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."
8 secondary outcomes
WOMAC change
Time frame: week 12
the change of Short Form 36 Questionnaire (SF-36) score from baseline to posttreatment
Time frame: week 12
Adverse drug reaction
Time frame: 12 weeks
Interleukin 1 beta
Time frame: 12 weeks
Serum level Tumor necrosis factor- alpha (TNF-α)
Time frame: 12 weeks
Serum levels of IL-17
Time frame: 12 weeks
Serum levels of BDNF
Time frame: 12 weeks
Serum levels of IL-10
Time frame: 12 WEEKS
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cilostazol 50 MG in people with Osteoarthritis, run by Sadat City University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue scale assessment of pain (time frame: week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.