Trial · NCT02184156

A Study to Evaluate Safety of Three Intra-articular Injections of Ampion in the Knee of Adults With Osteoarthritis Pain

NCT02184156, Phase 1, Phase 2, Completed, Ampio Pharmaceuticals. Inc.; results first posted 2022-09-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Evaluate Safety of Three Intra-articular Injections of Ampion in the Knee of Adults With Osteoarthritis Pain. Trials, record NCT02184156. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02184156

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study to Evaluate Safety of Three Intra-articular Injections of Ampion in the Knee of Adults With Osteoarthritis Pain
NCT number: NCT02184156
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 47 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: 2014-07-09
Last updated: 2022-09-30
Results first posted: 2022-09-30
Limitations and caveats: The Phase 2 study was underpowered to detect a statistically significant change in function.

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Incidence and Severity of Adverse Events and Serious Adverse Events (Phase 1)	24 Weeks	Incidence and severity of adverse events and serious adverse events evaluated at 24 weeks
Primary	Change in Knee Pain (Phase 2)	Scored at Baseline and 20 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 (Phase 2)	Scored at Baseline and 20 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	Incidence and Severity of Adverse Events and Serious Adverse Events (Phase 1)	24 Weeks	Safety Population	events	NUMBER
PRIMARY	Change in Knee Pain (Phase 2)	Scored at Baseline and 20 Weeks	Intent to Treat (ITT)	score on a scale	MEAN
SECONDARY	Change in Knee Function (Phase 2)	Scored at Baseline and 20 Weeks	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
Incidence and Severity of Adverse Events and Serious Adverse Events (Phase 1)	Phase 1 - Ampion 4 mL Injection	Serious Adverse Event	0		events
Incidence and Severity of Adverse Events and Serious Adverse Events (Phase 1)	Phase 1 - Ampion 4 mL Injection	Any Adverse Event	15		events
Change in Knee Pain (Phase 2)	Ampion 4 mL Injection		-1.41	Standard Deviation 0.81	score on a scale
Change in Knee Pain (Phase 2)	Placebo 4 mL Injection		-0.85	Standard Deviation 0.64	score on a scale
Change in Knee Function (Phase 2)	Ampion < 5 kDa Ultrafiltrate of 5% HSA		-1.27	Standard Deviation 0.81	score on a scale
Change in Knee Function (Phase 2)	Placebo Solution		-0.98	Standard Deviation 0.69	score on a scale

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Phase 1 Safety	STARTED	Ampion 4mL	7
Phase 1 Safety	STARTED	Placebo 4 mL	0
Phase 1 Safety	COMPLETED	Ampion 4mL	7
Phase 1 Safety	COMPLETED	Placebo 4 mL	0
Phase 1 Safety	NOT COMPLETED	Ampion 4mL	0
Phase 1 Safety	NOT COMPLETED	Placebo 4 mL	0
Phase 2 20 Week Efficacy	STARTED	Ampion 4mL	20
Phase 2 20 Week Efficacy	STARTED	Placebo 4 mL	20
Phase 2 20 Week Efficacy	COMPLETED	Ampion 4mL	19
Phase 2 20 Week Efficacy	COMPLETED	Placebo 4 mL	19

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events138

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
other	Vision Blurred	Eye disorders	Ampion 4 mL (Phase 1)	0	7
other	Vision Blurred	Eye disorders	Ampion 4 mL (Phase 2)	1	20
other	Vision Blurred	Eye disorders	Placebo 4 mL (Phase 2)	0	20
other	Colitis	Gastrointestinal disorders	Ampion 4 mL (Phase 1)	0	7
other	Colitis	Gastrointestinal disorders	Ampion 4 mL (Phase 2)	0	20
other	Colitis	Gastrointestinal disorders	Placebo 4 mL (Phase 2)	1	20
other	Gastrooesophageal Reflux Disease	Gastrointestinal disorders	Ampion 4 mL (Phase 1)	1	7
other	Gastrooesophageal Reflux Disease	Gastrointestinal disorders	Ampion 4 mL (Phase 2)	1	20
other	Gastrooesophageal Reflux Disease	Gastrointestinal disorders	Placebo 4 mL (Phase 2)	0	20
other	Nausea	Gastrointestinal disorders	Ampion 4 mL (Phase 1)	0	7

1 to 10 of 138Source ClinicalTrials.gov

See all 138 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ampion 4 mL (Phase 1)	0	7
Total, all-cause mortality	Ampion 4 mL (Phase 2)	0	20
Total, all-cause mortality	Placebo 4 mL (Phase 2)	0	20
Total, other adverse events	Ampion 4 mL (Phase 1)	6	7
Total, other adverse events	Ampion 4 mL (Phase 2)	19	20
Total, other adverse events	Placebo 4 mL (Phase 2)	16	20
Total, serious adverse events	Ampion 4 mL (Phase 1)	0	7
Total, serious adverse events	Ampion 4 mL (Phase 2)	3	20
Total, serious adverse events	Placebo 4 mL (Phase 2)	0	20

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
27684085	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 comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT02184156

GET https://conductscience.org/api/trials/v1/NCT02184156/events?page=2

API reference For AI assistants