Trial · NCT03988023
Study of Ampion for the Treatment of Pain and Function in Patients With Severe Osteoarthritis of the Knee.
NCT03988023, Phase 3, Terminated, Ampio Pharmaceuticals. Inc.; results first posted 2022-10-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Ampion for the Treatment of Pain and Function in Patients With Severe Osteoarthritis of the Knee. Trials, record NCT03988023. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03988023
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Ampion for the Treatment of Pain and Function in Patients With Severe Osteoarthritis of the Knee.
- NCT number
- NCT03988023
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 1,043 participants, actual
- Lead sponsor
- Ampio Pharmaceuticals. Inc.
- Conditions
- Severe Osteoarthritis of the Knee
- Interventions
- Ampion, Saline
- First posted
- 2019-06-17
- Last updated
- 2022-10-05
- Results first posted
- 2022-10-05
- Limitations and caveats
- The AP-013 study was prematurely terminated by the sponsor after Data Safety Monitoring Board (DSMB) guidance.
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 Week | 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. |
| Primary | 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
Outcomes2
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 Week | Intent to Treat (ITT) | Score on a scale | MEAN |
| PRIMARY | Change in Knee Function | Scored at Baseline and 12 weeks. | Intent to Treat (ITT) | Score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group4
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 | Ampion 4 mL Dose | -0.66 | 95% Confidence Interval -0.73 to -0.61 | Score on a scale | |
| Change in Knee Pain | Placebo 4 mL Dose | -0.71 | 95% Confidence Interval -0.76 to -0.64 | Score on a scale | |
| Change in Knee Function | Ampion 4 mL Dose | -0.68 | 95% Confidence Interval -0.75 to -0.62 | Score on a scale | |
| Change in Knee Function | Placebo 4 mL Dose | -0.73 | 95% Confidence Interval -0.79 to -0.67 | 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 | Ampion 4 mL Dose | 520 | |
| Overall Study | STARTED | Placebo 4 mL Dose | 523 | |
| Overall Study | COMPLETED | Ampion 4 mL Dose | 235 | |
| Overall Study | COMPLETED | Placebo 4 mL Dose | 235 | |
| Overall Study | NOT COMPLETED | Ampion 4 mL Dose | 285 | |
| Overall Study | NOT COMPLETED | Placebo 4 mL Dose | 288 |
Source ClinicalTrials.gov
Adverse events102
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 | Arthralgia | Musculoskeletal and connective tissue disorders | Ampion 4 mL Dose | 30 | 520 | 33 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Placebo 4 mL Dose | 35 | 523 | 41 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Ampion 4 mL Dose | 8 | 520 | 8 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Placebo 4 mL Dose | 6 | 523 | 6 |
| other | Joint stiffness | Musculoskeletal and connective tissue disorders | Ampion 4 mL Dose | 8 | 520 | 8 |
| other | Joint stiffness | Musculoskeletal and connective tissue disorders | Placebo 4 mL Dose | 7 | 523 | 8 |
| other | Joint swelling | Musculoskeletal and connective tissue disorders | Ampion 4 mL Dose | 4 | 520 | 4 |
| other | Joint swelling | Musculoskeletal and connective tissue disorders | Placebo 4 mL Dose | 5 | 523 | 5 |
| other | Osteoarthritis | Musculoskeletal and connective tissue disorders | Ampion 4 mL Dose | 5 | 520 | 5 |
| other | Osteoarthritis | Musculoskeletal and connective tissue disorders | Placebo 4 mL Dose | 5 | 523 | 5 |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ampion 4 mL Dose | 1 | 520 |
| Total, all-cause mortality | Placebo 4 mL Dose | 0 | 523 |
| Total, other adverse events | Ampion 4 mL Dose | 154 | 520 |
| Total, other adverse events | Placebo 4 mL Dose | 162 | 523 |
| Total, serious adverse events | Ampion 4 mL Dose | 16 | 520 |
| Total, serious adverse events | Placebo 4 mL Dose | 11 | 523 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|---|
| Ampion 4 mL Dose vs Placebo 4 mL Dose: deaths from any cause | Trial comparisons |
| Ampion 4 mL Dose vs Placebo 4 mL Dose: 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/NCT03988023
GET https://conductscience.org/api/trials/v1/NCT03988023/events?page=2