Trial Outcomes & Findings for A Randomized, Controlled Study to Evaluate Efficacy and Safety of Intra-articular Ampion for Osteoarthritis Pain in Knee (NCT NCT02024529)

NCT ID: NCT02024529

Last Updated: 2022-08-09

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

538 participants

Primary outcome timeframe

Scored at Baseline and 12 weeks

Results posted on

2022-08-09

Participant Flow

Recruitment of subjects occurred in medical clinics during the months of January and February 2014.

No pharmacological or non-pharmacological treatment targeting osteoarthritis (OA) started or changed during the 4 weeks prior to randomization or likely to be changed during the duration of the study.

Participant milestones

Participant milestones
Measure	Ampion 4 mL Injection 4 mL Intra-articular injection of Ampion	Placebo 4 mL Injection 4 mL placebo intra-articular injection Placebo: Saline
Overall Study STARTED	269	269
Overall Study COMPLETED	256	244
Overall Study NOT COMPLETED	13	25

Reasons for withdrawal

Reasons for withdrawal
Measure	Ampion 4 mL Injection 4 mL Intra-articular injection of Ampion	Placebo 4 mL Injection 4 mL placebo intra-articular injection Placebo: Saline
Overall Study Withdrawal by Subject	11	21
Overall Study Lost to Follow-up	2	4

Baseline Characteristics

A Randomized, Controlled Study to Evaluate Efficacy and Safety of Intra-articular Ampion for Osteoarthritis Pain in Knee

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ampion 4 mL Injection n=269 Participants 4 mL Intra-articular injection of Ampion	Placebo 4 mL Injection n=269 Participants 4 mL placebo intra-articular injection	Total n=538 Participants Total of all reporting groups
Age, Continuous	60.1 years STANDARD_DEVIATION 9.5 • n=99 Participants	61.2 years STANDARD_DEVIATION 9.6 • n=107 Participants	60.6 years STANDARD_DEVIATION 9.2 • n=206 Participants
Sex: Female, Male Female	151 Participants n=99 Participants	159 Participants n=107 Participants	310 Participants n=206 Participants
Sex: Female, Male Male	118 Participants n=99 Participants	110 Participants n=107 Participants	228 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	16 Participants n=99 Participants	18 Participants n=107 Participants	34 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	253 Participants n=99 Participants	251 Participants n=107 Participants	504 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=99 Participants	0 Participants n=107 Participants	3 Participants n=206 Participants
Race (NIH/OMB) Asian	4 Participants n=99 Participants	7 Participants n=107 Participants	11 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	48 Participants n=99 Participants	35 Participants n=107 Participants	83 Participants n=206 Participants
Race (NIH/OMB) White	214 Participants n=99 Participants	219 Participants n=107 Participants	433 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	5 Participants n=107 Participants	5 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	3 Participants n=107 Participants	3 Participants n=206 Participants
Region of Enrollment United States	269 participants n=99 Participants	269 participants n=107 Participants	538 participants n=206 Participants
Weight (kg)	96.1 kg STANDARD_DEVIATION 24.0 • n=99 Participants	95.1 kg STANDARD_DEVIATION 21.9 • n=107 Participants	95.6 kg STANDARD_DEVIATION 23.0 • n=206 Participants
BMI (kg/m^2)	34.2 kg/m^2 STANDARD_DEVIATION 8.1 • n=99 Participants	34.2 kg/m^2 STANDARD_DEVIATION 7.6 • n=107 Participants	34.2 kg/m^2 STANDARD_DEVIATION 7.9 • n=206 Participants
Kellgren-Lawrence (KL) Grade Kellgren-Lawrence Grade II	67 Participants n=99 Participants	66 Participants n=107 Participants	133 Participants n=206 Participants
Kellgren-Lawrence (KL) Grade Kellgren-Lawrence Grade III	105 Participants n=99 Participants	90 Participants n=107 Participants	195 Participants n=206 Participants
Kellgren-Lawrence (KL) Grade Kellgren-Lawrence Grade IV	97 Participants n=99 Participants	113 Participants n=107 Participants	210 Participants n=206 Participants
WOMAC Pain	2.38 score on a scale STANDARD_DEVIATION 0.56 • n=99 Participants	2.38 score on a scale STANDARD_DEVIATION 0.58 • n=107 Participants	2.38 score on a scale STANDARD_DEVIATION 0.57 • n=206 Participants
WOMAC Function	2.45 score on a scale STANDARD_DEVIATION 0.60 • n=99 Participants	2.41 score on a scale STANDARD_DEVIATION 0.63 • n=107 Participants	2.43 score on a scale STANDARD_DEVIATION 0.61 • n=206 Participants

PRIMARY outcome

Timeframe: Scored at Baseline and 12 weeks

Population: Intent to Treat (ITT)

Outcome measures

Outcome measures
Measure	Ampion 4 mL Injection n=269 Participants 4 mL Intra-articular injection of Ampion Ampion: \<5 kiloDalton (kDa) ultrafiltrate of 5% human serum albumin	Placebo 4 mL Injection n=269 Participants 4 mL placebo intra-articular injection Placebo: Saline
Change in WOMAC A Pain	-0.81 score on a scale Interval -0.91 to -0.71	-0.81 score on a scale Interval -0.91 to -0.7

SECONDARY outcome

Timeframe: Scored at Baseline and 12 weeks.

Population: Intent to Treat (ITT)

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.

Outcome measures

Outcome measures
Measure	Ampion 4 mL Injection n=269 Participants 4 mL Intra-articular injection of Ampion Ampion: \<5 kiloDalton (kDa) ultrafiltrate of 5% human serum albumin	Placebo 4 mL Injection n=269 Participants 4 mL placebo intra-articular injection Placebo: Saline
Change in WOMAC C Function	-0.76 score on a scale Interval -0.87 to -0.66	-0.77 score on a scale Interval -0.88 to -0.67

POST_HOC outcome

Timeframe: Scored at Baseline and 12 weeks

Population: Intent to Treat (ITT)

Outcome measures

Outcome measures
Measure	Ampion 4 mL Injection n=97 Participants 4 mL Intra-articular injection of Ampion Ampion: \<5 kiloDalton (kDa) ultrafiltrate of 5% human serum albumin	Placebo 4 mL Injection n=113 Participants 4 mL placebo intra-articular injection Placebo: Saline
Change in WOMAC A Pain of KL Grade IV Subset	-0.82 score on a scale Interval -0.99 to -0.66	-0.65 score on a scale Interval -0.81 to -0.49

POST_HOC outcome

Timeframe: Scored at Baseline and 12 Weeks

Population: Intent to Treat (ITT)

Outcome measures

Outcome measures
Measure	Ampion 4 mL Injection n=97 Participants 4 mL Intra-articular injection of Ampion Ampion: \<5 kiloDalton (kDa) ultrafiltrate of 5% human serum albumin	Placebo 4 mL Injection n=113 Participants 4 mL placebo intra-articular injection Placebo: Saline
Change in WOMAC C Function of KL Grade IV Subset	-0.73 score on a scale Interval -0.91 to -0.56	-0.69 score on a scale Interval -0.85 to -0.52

Adverse Events

Ampion 4 mL Injection

Serious events: 6 serious events

Other events: 65 other events

Deaths: 0 deaths

Placebo 4 mL Injection

Serious events: 4 serious events

Other events: 71 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ampion 4 mL Injection n=269 participants at risk 4 mL Intra-articular injection of Ampion Ampion: kDa ultrafiltrate of 5% human serum albumin	Placebo 4 mL Injection n=269 participants at risk 4 mL placebo intra-articular injection Placebo: Saline
Cardiac disorders Atrial Fibrillation	0.37% 1/269 • Number of events 1 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.	0.00% 0/269 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.
Infections and infestations Cellulitis	0.37% 1/269 • Number of events 1 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.	0.00% 0/269 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.
Infections and infestations Pneumonia	1.1% 3/269 • Number of events 3 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.	0.00% 0/269 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.
Injury, poisoning and procedural complications Hip Fracture	0.37% 1/269 • Number of events 1 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.	0.00% 0/269 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of Colon	0.00% 0/269 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.	0.37% 1/269 • Number of events 1 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's Lymphoma	0.00% 0/269 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.	0.37% 1/269 • Number of events 1 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.
Nervous system disorders Presyncope	0.00% 0/269 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.	0.37% 1/269 • Number of events 1 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.
Renal and urinary disorders Nephrolithiasis	0.37% 1/269 • Number of events 1 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.	0.00% 0/269 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.
Reproductive system and breast disorders Ovarian Cyst	0.00% 0/269 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.	0.37% 1/269 • Number of events 1 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.

Other adverse events

Other adverse events
Measure	Ampion 4 mL Injection n=269 participants at risk 4 mL Intra-articular injection of Ampion Ampion: kDa ultrafiltrate of 5% human serum albumin	Placebo 4 mL Injection n=269 participants at risk 4 mL placebo intra-articular injection Placebo: Saline
Musculoskeletal and connective tissue disorders Arthralgia	13.0% 35/269 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.	11.2% 30/269 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.
Infections and infestations Upper Respiratory Tract Infection	2.6% 7/269 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.	4.1% 11/269 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.
Musculoskeletal and connective tissue disorders Pain in Extremity	2.2% 6/269 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.	1.5% 4/269 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.
Infections and infestations Sinusitis	1.5% 4/269 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.	2.2% 6/269 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.
Injury, poisoning and procedural complications Fall	1.9% 5/269 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.	1.5% 4/269 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.
General disorders Injection Site Pain	1.5% 4/269 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.	1.9% 5/269 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.
Infections and infestations Bronchitis	1.1% 3/269 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.	1.9% 5/269 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.
Injury, poisoning and procedural complications Contusion	0.37% 1/269 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.	2.2% 6/269 • 12 Weeks Patients will be followed for the occurrence of Adverse Events until 12 weeks after the first dose of study medication.

Additional Information

Dr. Howard Levy / Chief Medical Officer

Ampio Pharmaceuticals

Phone: 7204376500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place