Osteoarthritis, KneePhase 1NCT00941746
Safety and Tolerability of PG110 in Patients With Knee Osteoarthritis Pain
A Phase 1 study testing PG110 in people with Osteoarthritis, Knee, run by Abbott at 1 site in Netherlands.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of a single intravenous dose of PG110, a monoclonal antibody that inhibits the effects of the naturally occurring substance, nerve growth factor (NGF). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- PG110
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2009to Jan 2011
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate to severe pain attributed to knee osteoarthritis
Who cannot join
- Significant comorbidity
- Significant pain states other than osteoarthritis
- Concomitant medications that might affect assessments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Single Ascending Dose, Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PG110 (Anti-NGF Monoclonal Antibody) in Patients With Pain Attributed to Osteoarthritis of the Knee
The purpose of this study is to evaluate the safety and tolerability of a single intravenous dose of PG110, a monoclonal antibody that inhibits the effects of the naturally occurring substance, nerve growth factor (NGF).
- Conditions
- Osteoarthritis, Knee
- Being tested
- PG110, Placebo
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PG110Biological
Single, slow intravenous infusion
PG110Biological
Single, slow intravenous infusion
PG110Biological
Single, slow intravenous infusion
PG110Biological
Single, slow intravenous infusion
PG110Biological
Single, slow intravenous infusion
PG110Biological
Single, slow intravenous infusion
PG110Biological
Single, slow intravenous infusion
PG110Biological
Single, slow intravenous infusion
PlaceboBiological
Single, slow intravenous infusion that matches PG110 in appearance
| Study group | Role | What they receive |
|---|---|---|
| Lowest dose of PG110 | Experimental | single, slow intravenous infusion Receives: Biological: PG110 |
| Second dose of PG110 | Experimental | single, slow intravenous infusion Receives: Biological: PG110 |
| Third dose of PG110 | Experimental | single, slow intravenous infusion Receives: Biological: PG110 |
| Fourth dose of PG110 | Experimental | single, slow intravenous infusion Receives: Biological: PG110 |
| Fifth dose of PG110 | Experimental | single, slow intravenous infusion Receives: Biological: PG110 |
| Top dose of PG110 | Experimental | single, slow intravenous infusion Receives: Biological: PG110 |
| Placebo | Experimental | single, slow intravenous infusion that matches PG110 in appearance Receives: Biological: Placebo |
| Seventh Dose of PG110 | Experimental | single, slow intravenous infusion Receives: Biological: PG110 |
| Eight Dose of PG110 | Experimental | single, slow intravenous infusion Receives: Biological: PG110 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number and severity of adverse events
Measured: Three months
Secondary outcomes (4)
Terminal elimination half-life
Measured: Three months
Dose proportionality of the area under the serum concentration-time curve
Measured: Three months
Pain in the index knee
Measured: Three months
Western Ontario and McMaster Universities questionnaire
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2009 (estimated)
- Study startAug 2009
- Primary completionJan 2011
- Study completionJan 2011
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
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jerry Hall, MD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00941746
- Sponsor's protocol ID
- PG110-01
- Other IDs
- 2008-006219-19, 2008
- Status last verified
- May 2011
- First submitted
- 14 Jul 2009
- Last updated
- 7 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, Single Ascending Dose, Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PG110 (Anti-NGF Monoclonal Antibody) in Patients With Pain Attributed to Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT00941746
- Acronym / sponsor ID
- PG110-01
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 20 Jul 2009 (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 evaluate the safety and tolerability of a single intravenous dose of PG110, a monoclonal antibody that inhibits the effects of the naturally occurring substance, nerve growth factor (NGF).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Lowest dose of PG110 | Experimental | Biological: PG110single, slow intravenous infusion |
| Second dose of PG110 | Experimental | Biological: PG110single, slow intravenous infusion |
| Third dose of PG110 | Experimental | Biological: PG110single, slow intravenous infusion |
| Fourth dose of PG110 | Experimental | Biological: PG110single, slow intravenous infusion |
| Fifth dose of PG110 | Experimental | Biological: PG110single, slow intravenous infusion |
| Top dose of PG110 | Experimental | Biological: PG110single, slow intravenous infusion |
| Placebo | Experimental | Biological: Placebosingle, slow intravenous infusion that matches PG110 in appearance |
| Seventh Dose of PG110 | Experimental | Biological: PG110single, slow intravenous infusion |
| Eight Dose of PG110 | Experimental | Biological: PG110single, slow intravenous infusion |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Moderate to severe pain attributed to knee osteoarthritis
Key exclusion criteria (3 listed)
- Significant comorbidity
- Significant pain states other than osteoarthritis
- Concomitant medications that might affect assessments
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 |
|---|---|---|
| PG110Single, slow intravenous infusion | Biological | Lowest dose of PG110 |
| PG110Single, slow intravenous infusion | Biological | Second dose of PG110 |
| PG110Single, slow intravenous infusion | Biological | Third dose of PG110 |
| PG110Single, slow intravenous infusion | Biological | Fourth dose of PG110 |
| PG110Single, slow intravenous infusion | Biological | Fifth dose of PG110 |
| PG110Single, slow intravenous infusion | Biological | Top dose of PG110 |
| PG110Single, slow intravenous infusion | Biological | Seventh Dose of PG110 |
| PG110Single, slow intravenous infusion | Biological | Eight Dose of PG110 |
| PlaceboSingle, slow intravenous infusion that matches PG110 in appearance | Biological | Placebo |
Primary outcome
The number and severity of adverse events
Time frame: Three months
4 secondary outcomes
Terminal elimination half-life
Time frame: Three months
Dose proportionality of the area under the serum concentration-time curve
Time frame: Three months
Pain in the index knee
Time frame: Three months
Western Ontario and McMaster Universities questionnaire
Time frame: Three months
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 7 Jun 2011.
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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.
Jerry Hall, MD study director
Abbott
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 PG110 in people with Osteoarthritis, Knee, run by Abbott at 1 site in Netherlands.
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 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 7 Jun 2011. 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 Netherlands. 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?
The number and severity of adverse events (time frame: Three months). 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 7 Jun 2011.