Osteoarthritis of the KneePhase 2NCT00667654
Safety and Tolerability of 4975 in the Treatment of Moderate to Severe Knee Pain Due to Osteoarthritis (OA)
A Phase 2 study testing CNTX-4975 in people with Osteoarthritis of the Knee, run by Centrexion Therapeutics at 1 site in United States.
Trial summary
This study will evaluate dosing regimens of 4975 in terms of safety and tolerability when delivered as an intra-articular injection in the knee. Secondary objectives will be to explore the efficacy of 4975 in terms of onset, extent and duration of pain relief. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- CNTX-4975
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Aug 2016
- Phase
- Phase 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged 40 years or over.
- Body mass index (BMI) of 35 or less.
- History of OA of the knee for at least 1 year and has experienced pain in the target area for at least six months.
- X-Ray of the target knee.
- Willing and able to complete the study procedures.
Who cannot join
- Female patients who are pregnant or lactating or who plan to get pregnant.
- Clinically significant form of joint disease other than OA.
- Medical condition that could adversely impact the patient's participation, safety or affect the conduct of the study.
- Prior major trauma in the target knee or major surgeries such as partial or total knee arthroplasty.
- Arthroscopic surgery on the target knee within 6 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Phamacology Study Group
Worcester, Massachusetts, 01610
About this study
Official title: A Phase 2, Open-label Study to Evaluate Safety and Tolerability, and to Explore the Efficacy, of Dosing Regimens of Intraarticular 4975 in Patients With Chronic Moderate to Severe Pain of the Knee Associated With Osteoarthritis
This study will evaluate dosing regimens of 4975 in terms of safety and tolerability when delivered as an intra-articular injection in the knee. Secondary objectives will be to explore the efficacy of 4975 in terms of onset, extent and duration of pain relief.
Read the detailed description
This is a single site study. The study drug, 4975, will be administered in various dosing regimens by intra-articular injection followed by an observation period of up to 12 weeks. Pain in the treated knee will be assessed before, during and after administration of the study drug.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- CNTX-4975
- Keywords
- Osteoarthritis, Knee
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CNTX-4975Drug
Testing a range of dosing configurations to optimize patient tolerability
| Study group | Role | What they receive |
|---|---|---|
| 100-200 µg CNTX-4975 | Experimental | single dose Receives: Drug: CNTX-4975 |
| 300-425 µg CNTX-4975 | Experimental | Total dose delivered as two separate lower doses Receives: Drug: CNTX-4975 |
| 600-700 µg CNTX-4975 | Experimental | Total dose delivered as two separate lower doses Receives: Drug: CNTX-4975 |
| 800 µg CNTX-4975 | Experimental | Total dose delivered as two separate lower doses Receives: Drug: CNTX-4975 |
| 900-1000 µg CNTX-4975 | Experimental | Total dose delivered as two separate lower doses Receives: Drug: CNTX-4975 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of IA CNTX-4975 as measured by related AEs occurring on day of dosing measures of pain at prescribed times
Measured: 12 Weeks
Secondary outcomes (2)
Evaluate analgesic efficacy, as measured by the PGIC, following IA injection of CNTX-4975
Measured: 12 Weeks
Change from baseline to Week 12 in WOMAC subscale score
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2008 (estimated)
- Study startAug 2007
- Primary completionJun 2008
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centrexion Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William C Houghton, MD, Study director, Anesiva, Inc.Shaun Comfort, MD, MBA, Study director, Anesiva, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00667654
- Sponsor's protocol ID
- 114-02P
- Status last verified
- Dec 2016
- First submitted
- 23 Apr 2008
- Last updated
- 6 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-label Study to Evaluate Safety and Tolerability, and to Explore the Efficacy, of Dosing Regimens of Intraarticular 4975 in Patients With Chronic Moderate to Severe Pain of the Knee Associated With Osteoarthritis
- ClinicalTrials.gov ID
- NCT00667654
- Acronym / sponsor ID
- 114-02P
- Conditions
- Osteoarthritis of the Knee
- Keywords
- Osteoarthritis, Knee
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Centrexion TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 28 Apr 2008 (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.
This study will evaluate dosing regimens of 4975 in terms of safety and tolerability when delivered as an intra-articular injection in the knee. Secondary objectives will be to explore the efficacy of 4975 in terms of onset, extent and duration of pain relief.
Detailed description
This is a single site study. The study drug, 4975, will be administered in various dosing regimens by intra-articular injection followed by an observation period of up to 12 weeks. Pain in the treated knee will be assessed before, during and after administration of the study drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 100-200 µg CNTX-4975 | Experimental | Drug: CNTX-4975single dose |
| 300-425 µg CNTX-4975 | Experimental | Drug: CNTX-4975Total dose delivered as two separate lower doses |
| 600-700 µg CNTX-4975 | Experimental | Drug: CNTX-4975Total dose delivered as two separate lower doses |
| 800 µg CNTX-4975 | Experimental | Drug: CNTX-4975Total dose delivered as two separate lower doses |
| 900-1000 µg CNTX-4975 | Experimental | Drug: CNTX-4975Total dose delivered as two separate lower doses |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patients aged 40 years or over.
- Body mass index (BMI) of 35 or less.
- History of OA of the knee for at least 1 year and has experienced pain in the target area for at least six months.
- X-Ray of the target knee.
- Willing and able to complete the study procedures.
Key exclusion criteria (5 listed)
- Female patients who are pregnant or lactating or who plan to get pregnant.
- Clinically significant form of joint disease other than OA.
- Medical condition that could adversely impact the patient's participation, safety or affect the conduct of the study.
- Prior major trauma in the target knee or major surgeries such as partial or total knee arthroplasty.
- Arthroscopic surgery on the target knee within 6 months.
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 |
|---|---|---|
| CNTX-4975Testing a range of dosing configurations to optimize patient tolerability | Drug | 100-200 µg CNTX-4975, 300-425 µg CNTX-4975, 600-700 µg CNTX-4975, 800 µg CNTX-4975, 900-1000 µg CNTX-4975 |
Primary outcome
To evaluate the safety of IA CNTX-4975 as measured by related AEs occurring on day of dosing measures of pain at prescribed times
Time frame: 12 Weeks
2 secondary outcomes
Evaluate analgesic efficacy, as measured by the PGIC, following IA injection of CNTX-4975
Time frame: 12 Weeks
Change from baseline to Week 12 in WOMAC subscale score
Time frame: Baseline to 12 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 6 Dec 2016.
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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.
William C Houghton, MD study director
Anesiva, Inc.
Shaun Comfort, MD, MBA study director
Anesiva, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CNTX-4975 in people with Osteoarthritis of the Knee, run by Centrexion Therapeutics 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 5 inclusion and 5 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 6 Dec 2016. 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 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 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?
To evaluate the safety of IA CNTX-4975 as measured by related AEs occurring on day of dosing measures of pain at prescribed times (time frame: 12 Weeks). 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 6 Dec 2016.