Osteoarthritis of the KneePhase 3NCT02556710

A Study to Evaluate the Efficacy & Safety of an Intra-Articular Ampion Injection for Pain of Osteoarthritis of the Knee

A Phase 3 study testing 4 mL injection of AMPION™ in people with Osteoarthritis of the Knee, run by Ampio Pharmaceuticals. Inc. at 1 site in United States.

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 and safety of an 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™
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 480 participants
Where: 1 siteUnited States
Study dates: Sep 2015to Jun 2016
Phase: Phase 3
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 OA and supported by radiological evidence (Kellgren Lawrence Grade II, III, or IV) read by a central reader;
WOMAC 5-point Likert pain subscale <1.5 in the contralateral knee;

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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);
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);
Ability to discontinue NSAID use at Screening visit and/or 72 hours prior to the Baseline visit and for the duration of the clinical study (low dose Aspirin is allowed during the study);
No analgesia (including acetaminophen [paracetamol]) taken 24 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

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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 osteoarthritis)
Major injury to the index knee within the 12 months prior to screening
Severe hip osteoarthritis 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
Pregnancy or planning to become pregnant during the study.
Use of the following medications:
No IA injected pain medications in the study knee during the study
No analgesics containing opioids.
NSAIDs are not permitted during the study; 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 low dose 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
No human albumin treatment in the 3 months before randomization or throughout the duration of the study

Trial locations and contacts

1 site in 1 country.

United States1 site

Ampio Pharmaceuticals
Englewood, Colorado, 80112

Other trials in United States

About this study

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

This study will evaluate the efficacy and safety of an 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 An Intra-Articular Injection Of AMPION™ In Adults With Pain Due to Osteoarthritis Of The Knee

The primary trial objective is to evaluate the efficacy of 4 mL of 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 is evaluation of the safety of an intra-articular injection of AMPION™.

Conditions: Osteoarthritis of the Knee
Being tested: 4 mL injection of AMPION™, 4 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 AMPION™Biological
4 mL Injection of Ampion
4 mL injection of PlaceboDrug
Also called Saline
4 mL Injection of Placebo

Study groups in NCT02556710
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

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 (1)

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

Timeline

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

Sep 2015Jun 2016

First posted22 Sep 2015 (estimated)
Study startSep 2015
Primary completionJun 2016
Study completionJun 2016

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 480 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02556710
Sponsor's protocol ID: AP-003-B
Status last verified: Aug 2022
First submitted: 18 Sep 2015
Last updated: 9 Aug 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Cole B, McGrath B, Salottolo K, Bar-Or D. LMWF-5A for the Treatment of Severe Osteoarthritis of the Knee: Integrated Analysis of Safety and Efficacy. Orthopedics. 2018 Jan 1;41(1):e77-e83. doi: 10.3928/01477447-20171114-05. Epub 2017 Nov 21.
PubMed 29156068

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?

See locations

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Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
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All Osteoarthritis of the Knee trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Placebo-Controlled, Double-Blind Study to Evaluated the Efficacy and Safety of an Intra-Articular Injection of AMPION™ in Adults With Pain Due to Osteoarthritis of the Knee
ClinicalTrials.gov ID: NCT02556710
Acronym / sponsor ID: AP-003-B
Conditions: Osteoarthritis of the Knee
Keywords: Osteoarthritis, Osteoarthritis of the Knee
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 480 participants (actual)
Lead sponsor: Ampio Pharmaceuticals. Inc.Industry (pharma, biotech, devices)
Study start: Sep 2015 (actual)
Primary completion: Jun 2016 (actual)
Study completion: Jun 2016 (actual)
First posted: 22 Sep 2015 (estimated)
Results: Posted 8 Aug 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 and safety of an 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 An Intra-Articular Injection Of AMPION™ In Adults With Pain Due to Osteoarthritis Of The Knee

The secondary trial objective is evaluation of the safety of an intra-articular injection of AMPION™.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
AMPION™ 4 mL dose	Experimental	Biological: 4 mL injection of AMPION™4 mL injection of Ampion
Placebo 4 mL dose	Placebo comparator	Drug: 4 mL injection of Placebo4 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 (11 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 OA and supported by radiological evidence (Kellgren Lawrence Grade II, III, or IV) read by a central reader;

Key exclusion criteria (22 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 AMPION™4 mL Injection of Ampion	Biological	AMPION™ 4 mL dose
4 mL injection of PlaceboAlso: Saline4 mL Injection of Placebo	Drug	Placebo 4 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.

1 secondary outcome

Change in Knee Function
Time frame: Scored at Baseline and 12 Weeks

Results and safety

Results posted to the registry on 8 Aug 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
4 mL AMPION™	237	226
4 mL Saline Placebo	243	237

Primary outcome: Change in Knee Pain

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

Measure	4 mL AMPION™ n = 237	4 mL Saline Placebo n = 243
Value	-0.91 (-1.03 to -0.80)	-0.89 (-1.01 to -0.77)

4 mL AMPION™ vs 4 mL Saline Placebo: p = 0.94, ANCOVA

Population analysed: Intent to Treat (ITT)

1 secondary outcome is 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
4 mL AMPION™	2 of 236 (0.8%)	47 of 236 (19.9%)	0 of 236
4 mL Saline Placebo	4 of 243 (1.6%)	44 of 243 (18.1%)	0 of 243

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 29156068Cole B, McGrath B, Salottolo K, Bar-Or D. LMWF-5A for the Treatment of Severe Osteoarthritis of the Knee: Integrated Analysis of Safety and Efficacy. Orthopedics. 2018 Jan 1;41(1):e77-e83. doi: 10.3928/01477447-20171114-05. Epub 2017 Nov 21.
Individual participant dataSharing planned: No

Related trials for Osteoarthritis of the Knee

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis

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.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 4 mL injection of AMPION™ in people with Osteoarthritis of the Knee, 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 11 inclusion and 22 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 9 Aug 2022. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 8 Aug 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 NCT02556710, 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 9 Aug 2022.