OsteoarthritisPhase 1NCT00454298
Study Evaluating AGG-523 in Subjects With Severe Osteoarthritis Requiring Total Knee Replacement
A Phase 1 study testing AGG-523 (Aggrecanase Inhibitor) in people with Osteoarthritis, run by Wyeth is now a wholly owned subsidiary of Pfizer at 5 sites in United States.
Trial summary
The main purpose of the study is to find out if, after 4 weeks of dosing, signs of the investigational drug AGG-523, or its effects, can be measured in urine, blood, or the knee joint. A secondary purpose is to evaluate the safety of taking the drug either once a day or twice a day for 4 weeks. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- AGG-523 (Aggrecanase Inhibitor)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 5 sitesUnited States
- Study dates
- May 2007to Mar 2008
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Generally healthy, men or women, at least 55 years old
- Osteoarthritis of the knee requiring total knee replacement surgery
Who cannot join
- Other types of arthritis, like rheumatoid arthritis
- Recent major surgery (in past 3 months)
- Recent knee injections (in past 6 months)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Study site
Boston, Massachusetts, 02120
Study site
Boston, Massachusetts, 02215
Study site
Newton, Massachusetts, 02462
Study site
Winchester, Massachusetts, 01801
Study site
Worcester, Massachusetts, 01655
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Regimen, Parallel-Group Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AGG-523 Administered Orally to Subjects With Severe Osteoarthritis
The main purpose of the study is to find out if, after 4 weeks of dosing, signs of the investigational drug AGG-523, or its effects, can be measured in urine, blood, or the knee joint. A secondary purpose is to evaluate the safety of taking the drug either once a day or twice a day for 4 weeks.
Read the detailed description
This is a multicenter study of 2 dosing regimens of AGG-523, an investigational aggrecanase inhibitor that is taken orally. Potential study subjects are those with severe Osteoarthritis (OA) of the knee who are scheduled to undergo total joint replacement surgery.
Study subjects will be randomly assigned to 1 of 2 dosing regimens (once-daily or twice-daily dosing) of either 1800 mg AGG-523 or placebo, which will be taken during the 4-week period before having the total knee replacement. The treatments will be assigned using a 4:1 ratio of active to placebo treatment, which means that more subjects will receive the active treatment than the placebo (see below).
- AGG-523 1800 mg once a day (32 subjects)
- AGG-523 900 mg twice a day (32 subjects)
- Placebo once a day (8 subjects)
- Placebo twice a day (8 subjects)
Study subjects will have weekly evaluations as outpatients during the 4-week dosing period. The purpose of these evaluations is to monitor for potential complications, ensure compliance with taking the study drug, ask about the use of other medications, and, when necessary, replenish the supply of study drug. These assessments may be conducted by telephone, as a home visit, or by having the subject travel to the clinic for an outpatient office visit. A final (in person) visit will happen 2 weeks after having total knee replacement surgery.
- Conditions
- Osteoarthritis
- Being tested
- AGG-523 (Aggrecanase Inhibitor)
- Keywords
- Severe Osteoarthritis, Arthritis
- Medical subject headings
- Osteoarthritis, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGG-523 (Aggrecanase Inhibitor)Drug
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | AGG-523 1800 mg QD PO (12 capsules) for 28 days Receives: Drug: AGG-523 (Aggrecanase Inhibitor) |
| B | Active comparator | AGG-523 900 mg BID PO (12 capsules) for 28 days Receives: Drug: AGG-523 (Aggrecanase Inhibitor) |
| C | Placebo comparator | Placebo QD PO (12 capsules) for 28 days Receives: Drug: AGG-523 (Aggrecanase Inhibitor) |
| D | Placebo comparator | Placebo BID PO (12 capsules) for 28 days Receives: Drug: AGG-523 (Aggrecanase Inhibitor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Using parts of the knee joint and the surrounding fluid that is taken out at the time of knee replacement, measure 1) the activity of aggrecansase (an enzyme that breaks down cartilage) and 2) the amount of study drug using lab tests.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2007 (estimated)
- Study startMay 2007
- Primary completionMar 2008
- Study completionMar 2008
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Montior, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00454298
- Sponsor's protocol ID
- 3189A1-106
- Status last verified
- Jul 2009
- First submitted
- 29 Mar 2007
- Last updated
- 29 Jul 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Regimen, Parallel-Group Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AGG-523 Administered Orally to Subjects With Severe Osteoarthritis
- ClinicalTrials.gov ID
- NCT00454298
- Acronym / sponsor ID
- 3189A1-106
- Conditions
- Osteoarthritis
- Keywords
- Severe Osteoarthritis, Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 30 Mar 2007 (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 main purpose of the study is to find out if, after 4 weeks of dosing, signs of the investigational drug AGG-523, or its effects, can be measured in urine, blood, or the knee joint. A secondary purpose is to evaluate the safety of taking the drug either once a day or twice a day for 4 weeks.
Detailed description
This is a multicenter study of 2 dosing regimens of AGG-523, an investigational aggrecanase inhibitor that is taken orally. Potential study subjects are those with severe Osteoarthritis (OA) of the knee who are scheduled to undergo total joint replacement surgery.
Study subjects will be randomly assigned to 1 of 2 dosing regimens (once-daily or twice-daily dosing) of either 1800 mg AGG-523 or placebo, which will be taken during the 4-week period before having the total knee replacement. The treatments will be assigned using a 4:1 ratio of active to placebo treatment, which means that more subjects will receive the active treatment than the placebo (see below).
- AGG-523 1800 mg once a day (32 subjects)
- AGG-523 900 mg twice a day (32 subjects)
- Placebo once a day (8 subjects)
- Placebo twice a day (8 subjects)
Study subjects will have weekly evaluations as outpatients during the 4-week dosing period. The purpose of these evaluations is to monitor for potential complications, ensure compliance with taking the study drug, ask about the use of other medications, and, when necessary, replenish the supply of study drug. These assessments may be conducted by telephone, as a home visit, or by having the subject travel to the clinic for an outpatient office visit. A final (in person) visit will happen 2 weeks after having total knee replacement surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: AGG-523 (Aggrecanase Inhibitor)AGG-523 1800 mg QD PO (12 capsules) for 28 days |
| B | Active comparator | Drug: AGG-523 (Aggrecanase Inhibitor)AGG-523 900 mg BID PO (12 capsules) for 28 days |
| C | Placebo comparator | Drug: AGG-523 (Aggrecanase Inhibitor)Placebo QD PO (12 capsules) for 28 days |
| D | Placebo comparator | Drug: AGG-523 (Aggrecanase Inhibitor)Placebo BID PO (12 capsules) for 28 days |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Generally healthy, men or women, at least 55 years old
- Osteoarthritis of the knee requiring total knee replacement surgery
Key exclusion criteria (3 listed)
- Other types of arthritis, like rheumatoid arthritis
- Recent major surgery (in past 3 months)
- Recent knee injections (in past 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 |
|---|---|---|
| AGG-523 (Aggrecanase Inhibitor) | Drug | A, B, C, D |
Primary outcome
Using parts of the knee joint and the surrounding fluid that is taken out at the time of knee replacement, measure 1) the activity of aggrecansase (an enzyme that breaks down cartilage) and 2) the amount of study drug using lab tests.
Time frame: 4 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 29 Jul 2009.
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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.
Medical Montior study director
Wyeth is now a wholly owned subsidiary of Pfizer
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AGG-523 (Aggrecanase Inhibitor) in people with Osteoarthritis, run by Wyeth is now a wholly owned subsidiary of Pfizer at 5 sites 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 2 inclusion and 3 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 29 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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. 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 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?
Using parts of the knee joint and the surrounding fluid that is taken out at the time of knee replacement, measure 1) the activity of aggrecansase (an enzyme that breaks down cartilage) and 2) the amount of study drug using lab tests. (time frame: 4 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 29 Jul 2009.