Osteoarthritis, KneePhase 1NCT02873273
Study of a Steroid Delivery System for Pain Relief Treatment in Patients With Knee Osteoarthritis
A Phase 1 study testing Dexamethasone in people with Osteoarthritis, Knee, run by Mark Figgie at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a longer duration, controlled, sustained release dexamethasone delivery system would be more effective in helping patients with osteoarthritis reduce their pain, remain functional, and delay their need for knee replacement. Read more about this study
- Who is it for?
- Ages 40 to 99 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2016to 21 Sep 2017
- Phase
- Phase 1
- 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 40 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥ 40 years of age at time of consent
- Diagnosis of unilateral or bilateral knee osteoarthritis for at least 6 months prior to screening with confirmation of osteoarthritis according to the American College of Rheumatology Criteria for Classification of Idiopathic Osteoarthritis of the Knee (clinical and radiological) based on an X-ray performed within 6 months prior to screening or during the screening period
- Kellgren - Lawrence grade ≥2 on weight bearing anteroposterior femorotibial radiograph performed within 6 months prior to or during screening period
- Mean score of ≥ 5 and ≤ 10 on the 24 hour average pain score (0 - 10 Numeric Rating System) during the screening period
- Body mass index (BMI) ≤ 40 kg/m2
- Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
- Willingness to stop all pain medications except acetaminophen and paracetamol 14 days prior to implantation
Who cannot join
- Fibromyalgia, chronic pain syndrome, or other concurrent medical or arthritic conditions which could interfere with the evaluation of the index knee
- History of inflammatory arthritis including rheumatoid arthritis, juvenile inflammatory arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, reactive arthritis
- Hemophilia
- Achondroplasia
- History of infection in the index joint
- Intra-articular corticosteroid (investigational or marketed) in any joint within three months of screening
Show all 19Show fewer
- Intra-articular hyaluronic acid (investigational or marketed) in the index knee within three months of screening
- Oral, inhaled, and intranasal corticosteroids (investigational or marketed) within one month of screening
- Prior arthroscopic or open surgery of the index knee within 12 months of screening
- Planned / anticipated surgery of the index knee during the study period
- Active or history of malignancy within the last five years, with the exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ
- Insulin dependent diabetes
- History of or active Cushing's syndrome
- Skin breakdown at index knee where procedure would take place
- Women of child-bearing potential
- Case history related to motor vehicle accident or workers compensation
- Presence of hardware in the index knee (e.g. screws, plates)
- Immunocompromised patients (TB, HIV, etc.)
- Allergic reactions to acetaminophen and paracetamol
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: A Pilot Study of a Dexamethasone Implant System in Humans
The purpose of this study is to determine whether a longer duration, controlled, sustained release dexamethasone delivery system would be more effective in helping patients with osteoarthritis reduce their pain, remain functional, and delay their need for knee replacement.
Read the detailed description
The objectives of the study are to assess the dexamethasone delivery system for:
- Safety and tolerability
- Efficacy
Formal statistical analysis to compare treatment groups will not be performed due to the small number of participants in this pilot study. Summary statistics will be assessed using the short form of the knee injury and osteoarthritis outcome score (KOOS JR) surveys and questionnaires to assess pain intensity, pain medication consumption and wound assessment.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Dexamethasone
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Sustained delivery system containing 5.0 mg of dexamethasone programmed to release an estimated 10 μg per day
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone delivery system | Experimental | Not described Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent adverse events
Measured: Through 24 weeks
Change from baseline in weekly mean of the pain intensity score
Using a numeric rating scale for pain with a scale of 0 (no pain) to 10 (worst pain imaginable) at rest, during activity, and at night
Measured: Weeks 12, 24
Secondary outcomes (10)
Change from baseline in weekly mean of the pain intensity score
Using a numeric rating scale for pain with a scale of 0 (no pain) to 10 (worst pain imaginable) at rest, during activity, and at night
Measured: Weekly through 24 weeks
Time of onset of pain relief
Measured: Weekly through 24 weeks
Change from baseline in KOOS-JR score (stiffness)
Using a response scale of none, mild, moderate, severe, and extreme
Measured: Over 1, 2, 4, 8, 12, 24 weeks post treatment
Change from baseline in KOOS-JR score (pain)
Using a response scale of none, mild, moderate, severe, and extreme
Measured: Over 1, 2, 4, 8, 12, 24 weeks post treatment
Change from baseline in KOOS-JR score (function)
Using a response scale of none, mild, moderate, severe, and extreme
Measured: Over 1, 2, 4, 8, 12, 24 weeks post treatment
Change in patient's global impression of scores assessed via office visits
Using a numeric rating scale for pain with a scale of 0 (no pain) to 10 (worst pain imaginable)
Measured: Weeks 4, 12, 24
Change in clinical observer's global impression of scores assessed via office visits
Using a numeric rating scale for pain with a scale of 0 (no pain) to 10 (worst pain imaginable)
Measured: Weeks 4, 12, 24
Percent of responders (defined as patients with high improvement in pain or function) according to OMERACT-OARSI criteria
Measured: Weeks 1, 2, 4, 8, 12, 24
Average weekly consumption of rescue medications
Measured: Through 24 weeks
Average total consumption of rescue medications
Measured: Through 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study start14 Oct 2016
- Primary completion21 Sep 2017
- Study completion21 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mark Figgie
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital for Special Surgery, New York
- Responsible party
- Sponsor-investigator, Mark Figgie, Hospital for Special Surgery, New York
- Investigators
- Mark Figgie, MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02873273
- Sponsor's protocol ID
- 2015-523
- Status last verified
- Sep 2018
- First submitted
- 5 Aug 2016
- Last updated
- 1 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of a Dexamethasone Implant System in Humans
- ClinicalTrials.gov ID
- NCT02873273
- Acronym / sponsor ID
- 2015-523
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Mark FiggieUniversity, hospital or other
- Collaborators
- Hospital for Special Surgery, New York
- Study start
- 14 Oct 2016 (actual)
- Primary completion
- 21 Sep 2017 (actual)
- Study completion
- 21 Sep 2017 (actual)
- First posted
- 19 Aug 2016 (estimated)
- 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.
The purpose of this study is to determine whether a longer duration, controlled, sustained release dexamethasone delivery system would be more effective in helping patients with osteoarthritis reduce their pain, remain functional, and delay their need for knee replacement.
Detailed description
The objectives of the study are to assess the dexamethasone delivery system for:
- Safety and tolerability
- Efficacy
Formal statistical analysis to compare treatment groups will not be performed due to the small number of participants in this pilot study. Summary statistics will be assessed using the short form of the knee injury and osteoarthritis outcome score (KOOS JR) surveys and questionnaires to assess pain intensity, pain medication consumption and wound assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone delivery system | Experimental | Drug: Dexamethasone |
Who may qualify
- Ages
- 40 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female ≥ 40 years of age at time of consent
- Diagnosis of unilateral or bilateral knee osteoarthritis for at least 6 months prior to screening with confirmation of osteoarthritis according to the American College of Rheumatology Criteria for Classification of Idiopathic Osteoarthritis of the Knee (clinical and radiological) based on an X-ray performed within 6 months prior to screening or during the screening period
- Kellgren - Lawrence grade ≥2 on weight bearing anteroposterior femorotibial radiograph performed within 6 months prior to or during screening period
- Mean score of ≥ 5 and ≤ 10 on the 24 hour average pain score (0 - 10 Numeric Rating System) during the screening period
- Body mass index (BMI) ≤ 40 kg/m2
Key exclusion criteria (19 listed)
- Fibromyalgia, chronic pain syndrome, or other concurrent medical or arthritic conditions which could interfere with the evaluation of the index knee
- History of inflammatory arthritis including rheumatoid arthritis, juvenile inflammatory arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, reactive arthritis
- Hemophilia
- Achondroplasia
- History of infection in the index joint
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 |
|---|---|---|
| DexamethasoneSustained delivery system containing 5.0 mg of dexamethasone programmed to release an estimated 10 μg per day | Drug | Dexamethasone delivery system |
Primary outcome
Incidence of treatment emergent adverse events
Time frame: Through 24 weeks
Change from baseline in weekly mean of the pain intensity score
Time frame: Weeks 12, 24
Using a numeric rating scale for pain with a scale of 0 (no pain) to 10 (worst pain imaginable) at rest, during activity, and at night
10 secondary outcomes
Change from baseline in weekly mean of the pain intensity score
Time frame: Weekly through 24 weeks
Time of onset of pain relief
Time frame: Weekly through 24 weeks
Change from baseline in KOOS-JR score (stiffness)
Time frame: Over 1, 2, 4, 8, 12, 24 weeks post treatment
Change from baseline in KOOS-JR score (pain)
Time frame: Over 1, 2, 4, 8, 12, 24 weeks post treatment
Change from baseline in KOOS-JR score (function)
Time frame: Over 1, 2, 4, 8, 12, 24 weeks post treatment
Change in patient's global impression of scores assessed via office visits
Time frame: Weeks 4, 12, 24
Change in clinical observer's global impression of scores assessed via office visits
Time frame: Weeks 4, 12, 24
Percent of responders (defined as patients with high improvement in pain or function) according to OMERACT-OARSI criteria
Time frame: Weeks 1, 2, 4, 8, 12, 24
Average weekly consumption of rescue medications
Time frame: Through 24 weeks
Average total consumption of rescue medications
Time frame: Through 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2018.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis, Knee
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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.
Mark Figgie, MD principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dexamethasone in people with Osteoarthritis, Knee, run by Mark Figgie at 1 site in United States.
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 7 inclusion and 19 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: finished, as of the sponsor's last update on 1 Oct 2018. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of treatment emergent adverse events (time frame: Through 24 weeks). The study lists 2 primary outcomes in all. 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 1 Oct 2018.