Trial · NCT02556710
A Study to Evaluate the Efficacy & Safety of an Intra-Articular Ampion Injection for Pain of Osteoarthritis of the Knee
NCT02556710, Phase 3, Completed, Ampio Pharmaceuticals. Inc.; results first posted 2022-08-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate the Efficacy & Safety of an Intra-Articular Ampion Injection for Pain of Osteoarthritis of the Knee. Trials, record NCT02556710. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02556710
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy & Safety of an Intra-Articular Ampion Injection for Pain of Osteoarthritis of the Knee
- NCT number
- NCT02556710
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 480 participants, actual
- Lead sponsor
- Ampio Pharmaceuticals. Inc.
- Conditions
- Osteoarthritis of the Knee
- Interventions
- 4 mL injection of AMPION™, 4 mL injection of Placebo
- First posted
- 2015-09-22
- Last updated
- 2022-08-09
- Results first posted
- 2022-08-08
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Knee Pain | 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. |
| Secondary | Change in Knee Function | Scored at Baseline and 12 Weeks | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Knee Pain | Scored at Baseline and 12 weeks | Intent to Treat (ITT) | score on a scale | MEAN |
| SECONDARY | Change in Knee Function | Scored at Baseline and 12 Weeks | Per Protocol (PP) | score on a scale | MEAN |
| POST_HOC | Change in Knee Pain of Kellgren-Lawrence Grade IV Subset | Scored at Baseline and 12 weeks | KL Grade IV Subset of Intent to Treat (ITT) | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Knee Pain | 4 mL AMPION™ | -0.91 | 95% Confidence Interval -1.03 to -0.80 | score on a scale | |
| Change in Knee Pain | 4 mL Saline Placebo | -0.89 | 95% Confidence Interval -1.01 to -0.77 | score on a scale | |
| Change in Knee Function | 4 mL AMPION™ | -1.04 | 95% Confidence Interval -1.17 to -0.92 | score on a scale | |
| Change in Knee Function | 4 mL Saline Placebo | -0.97 | 95% Confidence Interval -1.10 to -0.85 | score on a scale | |
| Change in Knee Pain of Kellgren-Lawrence Grade IV Subset | AMPION™ 4 mL Dose | -0.81 | 95% Confidence Interval -1.02 to -0.61 | score on a scale | |
| Change in Knee Pain of Kellgren-Lawrence Grade IV Subset | Placebo 4 mL Dose | -0.62 | 95% Confidence Interval -0.85 to -0.40 | score on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 4 mL AMPION™ | 237 | |
| Overall Study | STARTED | 4 mL Saline Placebo | 243 | |
| Overall Study | COMPLETED | 4 mL AMPION™ | 226 | |
| Overall Study | COMPLETED | 4 mL Saline Placebo | 237 | |
| Overall Study | NOT COMPLETED | 4 mL AMPION™ | 11 | |
| Overall Study | NOT COMPLETED | 4 mL Saline Placebo | 6 |
Source ClinicalTrials.gov
Adverse events30
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | 4 mL AMPION™ | 10 | 236 | 10 |
| other | Nasopharyngitis | Infections and infestations | 4 mL Saline Placebo | 10 | 243 | 10 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | 4 mL AMPION™ | 11 | 236 | 11 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | 4 mL Saline Placebo | 8 | 243 | 8 |
| other | Upper Respiratory Tract Infection | Infections and infestations | 4 mL AMPION™ | 6 | 236 | 6 |
| other | Upper Respiratory Tract Infection | Infections and infestations | 4 mL Saline Placebo | 13 | 243 | 13 |
| other | Sinusitis | Infections and infestations | 4 mL AMPION™ | 6 | 236 | 6 |
| other | Sinusitis | Infections and infestations | 4 mL Saline Placebo | 4 | 243 | 4 |
| other | Headache | Nervous system disorders | 4 mL AMPION™ | 5 | 236 | 5 |
| other | Headache | Nervous system disorders | 4 mL Saline Placebo | 2 | 243 | 2 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 4 mL AMPION™ | 0 | 236 |
| Total, all-cause mortality | 4 mL Saline Placebo | 0 | 243 |
| Total, other adverse events | 4 mL AMPION™ | 47 | 236 |
| Total, other adverse events | 4 mL Saline Placebo | 44 | 243 |
| Total, serious adverse events | 4 mL AMPION™ | 2 | 236 |
| Total, serious adverse events | 4 mL Saline Placebo | 4 | 243 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29156068 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| 4 mL AMPION™ vs 4 mL Saline Placebo: deaths from any cause | Trial comparisons |
| 4 mL AMPION™ vs 4 mL Saline Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02556710
GET https://conductscience.org/api/trials/v1/NCT02556710/events?page=2