Osteoarthritis of the KneePhase 2NCT01839331

An Efficacy and Safety Study of Two Doses of Intra-Articular Ampion Injection for Pain of Osteoarthritis of the Knee

A Phase 2 study testing 4 mL injection of Ampion and 10 mL Injection of Ampion in people with Osteoarthritis of the Knee, run by Ampio Pharmaceuticals. Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will evaluate the efficacy of two doses of Intra-Articular Injection of Ampion™ in Adults with pain due to osteoarthritis of the knee. Read more about this study

Who is it for?: Ages 40 to 85 years
Conditions the study is for: Osteoarthritis of the Knee
What is being tested?: 4 mL injection of Ampion and 10 mL Injection of Ampion
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 329 participants
Where: No sites listed yet
Study dates: 29 Mar 2013to Oct 2013
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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)
Must be ambulatory
Index knee must be symptomatic for greater than 6 months with a clinical diagnosis of osteoarthritis (OA) and supported by radiological evidence Kellgren Lawrence Grade II to IV) that is not older than 6 months prior to the date of screening
Moderate to moderately-severe OA pain in the index knee (rating of at least 1.5 on the WOMAC Index 3.1 5-point Likert Pain Subscale) assessed at screening

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Moderate to moderately-severe OA pain in the index knee (even if chronic doses of nonsteroidal anti-inflammatory drug (NSAID), which have not changed in the 4 weeks prior to screening, have been/are being used)
No analgesia (including acetaminophen [paracetamol]) taken 12 hours prior to an efficacy measure
No known clinically significant liver abnormality e.g. cirrhosis, transplant, etc.)

Who cannot join

As a result of medical review and screening investigation, the Principal Investigator considers the patient unfit for the study
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)
Presence of tense effusions
Inflammatory or crystal arthropathies, acute fractures, history of aseptic necrosis or joint replacement in the affected knee, as assessed locally by the Principal Investigator
Isolated patella femoral syndrome, also known as chondromalacia

Show all 20Show fewer

Any other disease or condition interfering with the free use and evaluation of the index knee for the duration of the trial e.g. cancer, congenital defects, spine OA)
Major injury to the index knee within the 12 months prior to screening
Severe hip OA ipsilateral to the index knee
Any pain that could interfere with the assessment of index knee pain (e.g. pain in any other part of the lower extremities, pain radiating to the knee)
Any pharmacological or non-pharmacological treatment targeting OA started or changed during the 4 weeks prior to randomization or likely to be changed during the duration of the study
Use of the following medications:
No IA injected pain medications in the study knee during the study
No analgesics containing opioids. NSAIDs may be continued at levels preceding the study and acetaminophen is available as a rescue medication during the study from the provided supply
No topical treatment on osteoarthritis index knee during the study
No significant anticoagulant therapy (e.g. Heparin or Lovenox) during the study (treatment such as Aspirin and Plavix are allowed)
No systemic treatments that may interfere with safety or efficacy assessments during the study
No immunosuppressants
No use of corticosteroids > 10 mg prednisolone equivalent per day (if ≤ 10 mg prednisolone, the dose must be stable)
Any human albumin treatment in the 3 months before randomization

About this study

Official title: A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of Two Doses of Intra-Articular Injection of Ampion™ in Adults With Pain Due to Osteoarthritis of the Knee

This study will evaluate the efficacy of two doses of Intra-Articular Injection of Ampion™ in Adults with pain due to osteoarthritis of the knee.

Read the detailed description

A Randomized, Placebo-controlled, Double-Blind Study to Evaluate the Efficacy and Safety of two Doses of Intra-Articular Injection of Ampion™ in Adults with pain due to osteoarthritis of the knee.

The primary trial objective is to evaluate whether there is greater efficacy of 10 mL Ampion™ versus 10 mL placebo than 4 mL Ampion™ versus 4 mL placebo intra-articular (IA) injection in improving knee pain, when applied to patients suffering from OA of the knee.

The secondary trial objective include: the evaluation of the safety of an intra-articular injection of Ampion™ when applied to patients suffering from OA of the knee, evaluation of the efficacy of intra-articular injection of Ampion™ and placebo on stiffness and function when applied to patients suffering from OA of the knee and evaluation of responder status defined by the Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) Criteria.

Conditions: Osteoarthritis of the Knee
Being tested: 4 mL injection of Ampion, 10 mL Injection of Ampion, 4 mL Injection of Placebo, 10 mL Injection of Placebo
Keywords: osteoarthritis, osteoarthritis of the knee
Medical subject headings: Osteoarthritis, Knee, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

4 mL injection of AmpionBiological
4 mL Injection of Ampion
10 mL Injection of AmpionBiological
10 mL Injection of Ampion
4 mL Injection of PlaceboDrug
Also called Saline
4 mL Injection of Placebo
10 mL Injection of PlaceboDrug
Also called Saline
10 mL Injection of Placebo

Study groups in NCT01839331
Study group	Role	What they receive
Ampion 4 mL Dose	Experimental	4 mL Injection of Ampion Receives: Biological: 4 mL injection of Ampion
Placebo 4 mL Dose	Placebo comparator	4 mL Injection of Placebo Receives: Drug: 4 mL Injection of Placebo
Ampion 10 mL Dose	Experimental	10 mL Injection of Ampion Receives: Biological: 10 mL Injection of Ampion
Placebo 10 mL Dose	Placebo comparator	10 mL Injection of Placebo Receives: Drug: 10 mL Injection of Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Knee Pain
Mean Change in WOMAC A Pain (Western Ontario and McMaster Universities Arthritis Index) score from Baseline to 12 weeks. 5-point Likert scale (0=none to 4=extreme). A negative difference constitutes a decrease in pain with a greater negative value indicating a greater reduction in pain.
Measured: Scored at Baseline and 12 weeks

Secondary outcomes (3)

Change in Knee Function
Mean change in WOMAC C function score (Western Ontario and McMaster Universities Arthritis Index) from Baseline to 12 weeks. 5-point Likert scale indicating limitation of function (0=none to 4=extreme). A greater negative value indicates a improvement in function.
Measured: Scored at Baseline and 12 weeks.
Change in Knee Stiffness.
Mean Change in WOMAC B stiffness score from Baseline to 12 weeks. 5-point Likert scale (0=none to 4=extreme). A negative difference constitutes a reduction in stiffness.
Measured: Scored at Baseline and 12 weeks.
Change in Patient's Global Assessment
Patients are asked the following question: "Considering all the ways in which your arthritis affects you, please indicate how you are doing." 5-point Likert scale (0 = very well, 1 = well, 2 = fair, 3 = poor, 4 = very poor). A negative value constitutes an improvement in patient's assessment of disease severity.
Measured: Scored at Baseline and 12 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Mar 2013Oct 2013

First posted24 Apr 2013 (estimated)
Study start29 Mar 2013
Primary completion19 Aug 2013
Study completionOct 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 329 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01839331
Sponsor's protocol ID: AP-003-A
Status last verified: Jun 2022
First submitted: 22 Apr 2013
Last updated: 30 Jun 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Bar-Or D, Salottolo KM, Loose H, Phillips MJ, McGrath B, Wei N, Borders JL, Ervin JE, Kivitz A, Hermann M, Shlotzhauer T, Churchill M, Slappey D, Clift V. A randomized clinical trial to evaluate two doses of an intra-articular injection of LMWF-5A in adults with pain due to osteoarthritis of the knee. PLoS One. 2014 Feb 3;9(2):e87910. doi: 10.1371/journal.pone.0087910. eCollection 2014.
PubMed 24498399

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Osteoarthritis of the Knee trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of Two Doses of Intra-Articular Injection of Ampion™ in Adults With Pain Due to Osteoarthritis of the Knee
ClinicalTrials.gov ID: NCT01839331
Acronym / sponsor ID: AP-003-A
Conditions: Osteoarthritis of the Knee
Keywords: osteoarthritis, osteoarthritis of the knee
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 329 participants (actual)
Lead sponsor: Ampio Pharmaceuticals. Inc.Industry (pharma, biotech, devices)
Study start: 29 Mar 2013 (actual)
Primary completion: 19 Aug 2013 (actual)
Study completion: Oct 2013 (actual)
First posted: 24 Apr 2013 (estimated)
Results: Posted 30 Jun 2022

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 efficacy of two doses of Intra-Articular Injection of Ampion™ in Adults with pain due to osteoarthritis of the knee.

Detailed description

A Randomized, Placebo-controlled, Double-Blind Study to Evaluate the Efficacy and Safety of two Doses of Intra-Articular Injection of Ampion™ in Adults with pain due to osteoarthritis of the knee.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Ampion 4 mL Dose	Experimental	Biological: 4 mL injection of Ampion4 mL Injection of Ampion
Placebo 4 mL Dose	Placebo comparator	Drug: 4 mL Injection of Placebo4 mL Injection of Placebo
Ampion 10 mL Dose	Experimental	Biological: 10 mL Injection of Ampion10 mL Injection of Ampion
Placebo 10 mL Dose	Placebo comparator	Drug: 10 mL Injection of Placebo10 mL Injection of Placebo

Who may qualify

Ages: 40 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 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)
Must be ambulatory
Index knee must be symptomatic for greater than 6 months with a clinical diagnosis of osteoarthritis (OA) and supported by radiological evidence Kellgren Lawrence Grade II to IV) that is not older than 6 months prior to the date of screening

Key exclusion criteria (20 listed)

As a result of medical review and screening investigation, the Principal Investigator considers the patient unfit for the study
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)
Presence of tense effusions
Inflammatory or crystal arthropathies, acute fractures, history of aseptic necrosis or joint replacement in the affected knee, as assessed locally by the Principal Investigator

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
4 mL injection of Ampion4 mL Injection of Ampion	Biological	Ampion 4 mL Dose
10 mL Injection of Ampion10 mL Injection of Ampion	Biological	Ampion 10 mL Dose
4 mL Injection of PlaceboAlso: Saline4 mL Injection of Placebo	Drug	Placebo 4 mL Dose
10 mL Injection of PlaceboAlso: Saline10 mL Injection of Placebo	Drug	Placebo 10 mL Dose

Primary outcome

Change in Knee Pain
Time frame: Scored at Baseline and 12 weeks
Mean Change in WOMAC A Pain (Western Ontario and McMaster Universities Arthritis Index) score from Baseline to 12 weeks. 5-point Likert scale (0=none to 4=extreme). A negative difference constitutes a decrease in pain with a greater negative value indicating a greater reduction in pain.

3 secondary outcomes

Change in Knee Function
Time frame: Scored at Baseline and 12 weeks.
Change in Knee Stiffness.
Time frame: Scored at Baseline and 12 weeks.
Change in Patient's Global Assessment
Time frame: Scored at Baseline and 12 weeks.

Results and safety

Results posted to the registry on 30 Jun 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ampion 4 mL Dose	83	79
Placebo 4 mL Dose	83	77
Ampion 10 mL Dose	82	77
Placebo 10 mL Dose	81	76

Primary outcome: Change in Knee Pain

Time frame: Scored at Baseline and 12 weeks. Mean (95% Confidence Interval). Unit: score on a scale

Measure	Ampion Combined (4 mL & 10 mL Dose) n = 165	Placebo Combined (4 mL and 10 mL Dose) n = 164	Ampion 4 mL Dose n = 83	Placebo 4 mL Dose n = 83	Ampion 10 mL Dose n = 82	Placebo 10 mL Dose n = 81
Value	-0.93 (-1.045 to -0.807)	-0.72 (-0.852 to -0.587)	-0.93 (-1.099 to -0.766)	-0.71 (-0.871 to -0.543)	-0.92 (-1.093 to -0.746)	-0.73 (-0.946 to -0.520)

Ampion Combined (4 mL & 10 mL Dose) vs Placebo Combined (4 mL and 10 mL Dose): p = 0.004, ANOVA
Ampion 4 mL Dose vs Placebo 4 mL Dose: p = 0.017, ANOVA
Ampion 10 mL Dose vs Placebo 10 mL Dose: p = 0.093, ANOVA

Population analysed: Intent to Treat (ITT)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 Weeks. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ampion 4 mL Dose	0 of 83 (0%)	23 of 83 (27.7%)	0 of 83
Placebo 4 mL Dose	2 of 83 (2.4%)	38 of 83 (45.8%)	0 of 83
Ampion 10 mL Dose	3 of 82 (3.7%)	17 of 82 (20.7%)	0 of 82
Placebo 10 mL Dose	2 of 81 (2.5%)	29 of 81 (35.8%)	0 of 81

Limitations and caveats (from the sponsor): The relatively small number of subjects in each arm may account for lack of statistical significance of improvement in Knee pain of 10 mL.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 24498399Bar-Or D, Salottolo KM, Loose H, Phillips MJ, McGrath B, Wei N, Borders JL, Ervin JE, Kivitz A, Hermann M, Shlotzhauer T, Churchill M, Slappey D, Clift V. A randomized clinical trial to evaluate two doses of an intra-articular injection of LMWF-5A in adults with pain due to osteoarthritis of the knee. PLoS One. 2014 Feb 3;9(2):e87910. doi: 10.1371/journal.pone.0087910. eCollection 2014.
Individual participant dataSharing planned: No

Related trials for Osteoarthritis of the Knee

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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.

Howard Levy, MD study director

Ampio Pharmaceuticals. Inc.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 4 mL injection of Ampion and 10 mL Injection of Ampion in people with Osteoarthritis of the Knee, run by Ampio Pharmaceuticals. Inc..

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 9 inclusion and 20 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 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

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 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?

Yes. Results are posted in the registry (first posted 30 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Knee Pain (time frame: Scored at Baseline and 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01839331, which also lists 1 linked publication.

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 30 Jun 2022.