Osteoarthritis of the HandPhase 1NCT02762760
AP-011 Study to Evaluate the Safety of a Single Intra-articular Injection of Ampion™ for Arthritis of the Basal Thumb Joint
A Phase 1 study testing AMPION™ and Saline in people with Osteoarthritis of the Hand, run by Ampio Pharmaceuticals. Inc. at 1 site in United States.
Trial summary
This study will evaluate the safety of an intra-articular injection of AMPION™ in adults with pain due to osteoarthritis of the basal thumb joint. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Osteoarthritis of the Hand
- What is being tested?
- AMPION™ and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Nov 2016
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide written informed consent to participate in the study.
- Willing and able to comply with all study requirements and instructions of the site study staff.
- Male or female, 40 years to 85 years old (inclusive).
- Radiographic evidence of Basal joint arthritis (Eaton-Littler classification, stages 1 through 4).
- Pain associated with basal joint arthritis, defined as a score ≥ 4 as evaluated by the Australian-Canadian OA Index (AUSCAN)-numeric rating score (NRS, 0-10).
Who cannot join
- As a result of medical review and screening investigation, the Principal Investigator considers the subject unfit for the study.
- Previous Ampion™ injection.
- A history of allergic reactions to human albumin (reaction to non-human albumin such as egg albumin is not an exclusion criterion).
- A history of allergic reactions to excipients in 5% human albumin (N-acetyltryptophan, sodium caprylate).
- Women who are currently pregnant or who could become pregnant.
- Inflammatory or crystal arthropathies, acute fractures, history of aseptic necrosis, as assessed locally by the Principal Investigator.
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- Any other disease or condition interfering with the free use and evaluation of the index thumb for the duration of the trial (e.g., congenital defects, stricture).
- Major injury to the index thumb within the 12 months prior to screening.
- Any pharmacological or non-pharmacological treatment targeting OA started or changed during the 4 weeks prior to treatment or likely to be changed during the duration of the study.
- Use of the following medications are exclusionary:
- IA injected pain medications in the study thumb during the study;
- Analgesics containing opioids;
- NSAIDs (including but not limited to ibuprofen, aspirin, naproxen, diclofenac) acetaminophen is available as a rescue medication during the study from the provided supply;
- Topical prescription treatment on osteoarthritis index thumb during the study;
- Significant anticoagulant therapy (e.g., Heparin or Lovenox) during the study (treatment such as Aspirin in the cardio-protective dose (81mg) and Plavix are allowed);
- Systemic treatments that may interfere with safety or efficacy assessments during the study;
- Immunosuppressants;
- Use of corticosteroids > 10 mg prednisolone equivalent per day (if ≤ 10 mg prednisolone, the dose must be stable, defined as chronic use of the same dose for at least 1 month).
- Any human albumin treatment in the 3 months before randomization.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Phase I Study to Evaluate the Safety of a Single Intra-articular Injection of Ampion™ as a Treatment for Arthritis of the Basal Thumb Joint
This study will evaluate the safety of an intra-articular injection of AMPION™ in adults with pain due to osteoarthritis of the basal thumb joint.
Read the detailed description
A prospective phase I study to evaluate the safety of a single intra-articular injection of Ampion™ as a treatment for arthritis of the basal thumb joint.
Primary Objective is:
To evaluate the safety of Ampion™ (up to 3 mL) in comparison to saline placebo (up to 3 mL) when injected into the basal thumb joint.
- Conditions
- Osteoarthritis of the Hand
- Being tested
- AMPION™, Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMPION™Biological
AMPION™, up to 3 mL, single intra-articular injection. Ampion is the ultrafiltrate of 5% HSA.
SalineBiological
Saline placebo, up to 3 mL, single intra-articular injection. Saline used as the comparator is 0.9% Sodium Chloride
| Study group | Role | What they receive |
|---|---|---|
| AMPION™ | Experimental | AMPION™, up to 3 mL, single intra-articular injection. Ampion is the ultrafiltrate of 5% HSA. Receives: Biological: AMPION™ |
| Saline | Experimental | Saline placebo, up to 3 mL, single intra-articular injection. Saline used as the comparator is 0.9% Sodium Chloride Receives: Biological: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety will be evaluated from Baseline to Week 4. monitoring incidence of AEs, thumb exam, vitals, and concomitant medication use
The Clinical safety of treatment on base of the thumb will be assessed by recording AEs at all in-clinic visits and the 24-hour, post-injection telephone contact call, by the results of the physical examination of the thumb joint and vital signs (at all in-clinic visits), and by recording prior and concomitant medications including start/stop dates, indication, dose and frequency (at 24 hour post-injection telephone contact call and all in-clinic visits).
Measured: Baseline to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startMay 2016
- Primary completionNov 2016
- Study completionNov 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 HandStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ampio Pharmaceuticals. Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Bar-Or, MD, Study director, Ampio Pharmaceuticals. Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02762760
- Sponsor's protocol ID
- AP-011
- Status last verified
- Oct 2016
- First submitted
- 2 May 2016
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Phase I Study to Evaluate the Safety of a Single Intra-articular Injection of Ampion™ as a Treatment for Arthritis of the Basal Thumb Joint
- ClinicalTrials.gov ID
- NCT02762760
- Acronym / sponsor ID
- AP-011
- Conditions
- Osteoarthritis of the Hand
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Ampio Pharmaceuticals. Inc.Industry (pharma, biotech, devices)
- Study start
- May 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 5 May 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.
This study will evaluate the safety of an intra-articular injection of AMPION™ in adults with pain due to osteoarthritis of the basal thumb joint.
Detailed description
A prospective phase I study to evaluate the safety of a single intra-articular injection of Ampion™ as a treatment for arthritis of the basal thumb joint.
Primary Objective is:
To evaluate the safety of Ampion™ (up to 3 mL) in comparison to saline placebo (up to 3 mL) when injected into the basal thumb joint.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMPION™ | Experimental | Biological: AMPION™AMPION™, up to 3 mL, single intra-articular injection. Ampion is the ultrafiltrate of 5% HSA. |
| Saline | Experimental | Biological: SalineSaline placebo, up to 3 mL, single intra-articular injection. Saline used as the comparator is 0.9% Sodium Chloride |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able to provide written informed consent to participate in the study.
- Willing and able to comply with all study requirements and instructions of the site study staff.
- Male or female, 40 years to 85 years old (inclusive).
- Radiographic evidence of Basal joint arthritis (Eaton-Littler classification, stages 1 through 4).
- Pain associated with basal joint arthritis, defined as a score ≥ 4 as evaluated by the Australian-Canadian OA Index (AUSCAN)-numeric rating score (NRS, 0-10).
Key exclusion criteria (19 listed)
- As a result of medical review and screening investigation, the Principal Investigator considers the subject unfit for the study.
- Previous Ampion™ injection.
- A history of allergic reactions to human albumin (reaction to non-human albumin such as egg albumin is not an exclusion criterion).
- A history of allergic reactions to excipients in 5% human albumin (N-acetyltryptophan, sodium caprylate).
- Women who are currently pregnant or who could become pregnant.
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 |
|---|---|---|
| AMPION™AMPION™, up to 3 mL, single intra-articular injection. Ampion is the ultrafiltrate of 5% HSA. | Biological | AMPION™ |
| SalineSaline placebo, up to 3 mL, single intra-articular injection. Saline used as the comparator is 0.9% Sodium Chloride | Biological | Saline |
Primary outcome
Safety will be evaluated from Baseline to Week 4. monitoring incidence of AEs, thumb exam, vitals, and concomitant medication use
Time frame: Baseline to 4 weeks
The Clinical safety of treatment on base of the thumb will be assessed by recording AEs at all in-clinic visits and the 24-hour, post-injection telephone contact call, by the results of the physical examination of the thumb joint and vital signs (at all in-clinic visits), and by recording prior and concomitant medications including start/stop dates, indication, dose and frequency (at 24 hour post-injection telephone contact call and all in-clinic visits).
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 15 Nov 2016.
- Individual participant dataSharing planned: Undecided
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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.
David Bar-Or, MD study director
Ampio Pharmaceuticals. Inc.
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 AMPION™ and Saline in people with Osteoarthritis of the Hand, run by Ampio Pharmaceuticals. Inc. 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 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 15 Nov 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 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?
Safety will be evaluated from Baseline to Week 4. monitoring incidence of AEs, thumb exam, vitals, and concomitant medication use (time frame: Baseline to 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 15 Nov 2016.