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Trial registered on ANZCTR


Registration number
ACTRN12611000940976
Ethics application status
Approved
Date submitted
1/07/2011
Date registered
1/09/2011
Date last updated
2/09/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Randomized, Controlled, Double-Blind Study of a Single Intra-Articular Injection of the less than 5,000 MW Fraction of Human Albumin 5% (Ampion-Trademark) in Adults with Osteoarthritis of the Knee
Scientific title
A Randomized, Controlled, Double-Blind Study of a Single Intra-Articular Injection of the less than 5,000 MW Fraction of Human Albumin 5% (Ampion-Trademark) in Adults with Osteoarthritis of the Knee for the Reduction of Pain
Secondary ID [1] 262535 0
Nil
Universal Trial Number (UTN)
U1111-1122-5164
Trial acronym
AIK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis of the knee 268203 0
Condition category
Condition code
Musculoskeletal 268332 268332 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The eligible patient will be randomized to receive a single 10mL intra-articular injection into the study knee of one of the following treatment:

1. Ampion (Trademark) (4mL) combined with lignocaine (4mL)/betamethasone suspension (2mL) OR

2. Ampion(Trademark) (4mL), combined with betamethasone suspension (2mL) OR

3.Saline (4mL) placebo combined with lignocaine (4mL)/betamethasone (2mL) suspension

Treatment 1 has Ampion combined with both betamethsone and lignocaine, whereas Treatment 2 a combination of Ampion with betamethasone but without lignocaine. Treatment 3, the Ampion is replaced with saline.
Intervention code [1] 266882 0
Treatment: Drugs
Comparator / control treatment
Saline placebo combined with lignocaine/betamethasone suspension
Control group
Placebo

Outcomes
Primary outcome [1] 269103 0
Assess the reduction in pain in subjects with knee osteoarthritis of a single intra-articular knee injection of Ampion(TM) combined with lignocaine/betamethasone suspension with Ampion (TM) combined with betamethasone suspension combined or compared with a saline placebo combined with lignocaine/betamethsone suspension.


This outcome will be assessed by the Western Ontario McMaster University Osteoarthritis (WOMAC) Index.
Timepoint [1] 269103 0
Single injection to study knee on Day 1 with clinical follow up over 72 hours.
Folllow up visits on Day 2 and Day 4.
Secondary outcome [1] 276938 0
Assess joint function and pain subjects by WOMAC index following injection.
Timepoint [1] 276938 0
Single injection to study knee on Day 1 with clinical follow up over 72 hours.
Folllow up visits on Day 2 and Day 4.
Secondary outcome [2] 276939 0
Assess the requirement for rescue medications in subjects with knee osteoarthritis following injection.

This outcome will be assessed by providing each patient with a diary card to record their medications.
Timepoint [2] 276939 0
Single injection to study knee on Day 1 with clinical follow up over 72 hours.
Folllow up visits on Day 2 and Day 4.
Secondary outcome [3] 276940 0
Assess effect on the range of motion and limited range of motion in the study knee due to pain and inflammation following injection.

The investigator will assess the patient's study knee will for degrees of flexion and extension using an instrument called a goniometer.
Timepoint [3] 276940 0
Single injection to study knee on Day 1 with clinical follow up over 72 hours.
Folllow up visits on Day 2 and Day 4.
Secondary outcome [4] 276941 0
Compare safety and tolerability between treatments as assessed by reported adverse events.

This will be assessed by type of adverse events reported (if any) by patients following injection. The adverse events will be given a diagnosis by the investigator and a severity is deemed and a resolution is recorded. Each patient will also their blood taken for standard biochemistry and haematology pathology test on Days 2 and 4.

The investigator will assess the results of their patholoy tests and any adverse events reported for the duration of the study to assess safety and tolerability of treatments.
Timepoint [4] 276941 0
Single injection to study knee on Day 1 with clinical follow up over 72 hours.
Folllow up visits on Day 2 and Day 4.

Eligibility
Key inclusion criteria
1. Male or female, 40 years to 85 years old (inclusive), fully ambulatory, willing to sign informed consent.
2. Symptomatic index knee osteoarthritis greater/equal to 6 months prior to screening with Kellgren Lawrence Grade II or III.
3. Symptoms in the index knee for at least 6 months preceding screening.
4. Because of the unknown effects of AmpionTM, women should avoid becoming pregnant during the course of this study if you become pregnant you will have to withdraw from the trial and your medical progress will be carefully followed. These precautions are necessary because the information on the effects on the unborn or new born baby of drugs like AmpionTM, is still very limited. Your own doctor, as well as the study coordinator should be able to assist you if you have any questions about the need to avoid pregnancy.
Because of the unknown effects of AmpionTM, on sperm and possibly on foetus, men should avoid any possibility of fathering a child during the course of this trial. If your partner does become pregnant you should notify the study coordinator and their medical progress will be monitored. These precautions are necessary because the information on the effects on the unborn or new born baby of drugs like AmpionTM, is still limited. Your own doctor, as well as the study coordinator, should be able to assist you if you have any questions about the need to avoid emitting sperm that might result in pregnancy.
5. Is able to provide written informed consent to participate in the study in accordance with local regulations, and is not under any guardianship provision.
6. Is willing and able to comply with all study requirements and instructions of the site study staff.
Minimum age
40 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. As a result of medical review and screening investigation (including electrocardiogram (ECG) and laboratory tests), the Principal Investigator considers the patient unfit for the study.
2. A history of allergic reactions to albumin (reaction to non human albumin such as egg albumin is not an exclusion criteria).
3. A history of allergic reactions to excipients in 5% human albumin (N-acetyltryptophan, sodium caprylate).
4. Any intra-articular or local periarticular injection, injection or surgery to the index knee during the 6 months prior to screening.
5. Operative arthroscopy within 3 months of screening.
6. Surgical procedure to the index knee other than arthroscopy within 12 months of participation in the trial.
7. Any investigational knee products within 12 months of participation in the trial.
8. Kellgren Lawrence Grade I or IV (doubtful or severe) osteoarthritis of the knee.
9. Inflammatory or crystal arthropathies, acute fractures, severe loss of bone density, bone necrosis.
10. Isolated patella-femoral syndrome or chondromalacia.
11. 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).
12. Major injury to the index knee within the 12 months prior to screening.
13. Severe hip osteoarthritis ipsilateral to the index knee.
14. 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).
15. Any pharmacological or non-pharmacological treatment started or changed during the
4 weeks prior to randomization or likely to be changed during the duration of the study.
16. Use of the following medications:
a. Any topical treatment on osteoarthritis knees within 48 hours prior to randomization.
b. All analgesics and NSAIDs except paracetamol within 48 hours prior to randomization
c. Anticoagulant therapy for 48 hours prior to randomization
d. Any systemic steroid treatments within 14 days prior to randomization
e. All immunosuppressives within a period of 5 times the drug’s half life prior to randomization
17. Use of corticosteroids greater than 10 mg prednisolone equivalent per day during the 30 days prior to randomization.
18. Any albumin treatment in the 3 months before randomization.
19. Female subjects who are pregnant or lactating.
20. Female subjects of childbearing potential who have a positive pregnancy test on Day 1 prior to treatment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential subjects will be screened to assess their eligibility. Treatment to each subject will be allocated by randomization. Randomization schedule will be maintained under controlled access.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects will be allocated to a sequentially numbered treatment in accordance with the randomization schedule following confirmation of eligibility at pre-dose. The randomization number will be in the form of a four digit number, Rsrnn, where s is the site number, r is the replacement indicator, and nn is the subject randomization number within site e.g. R1006. If a subject is replaced, the second digit is incremented by one, and the same treatment is administered to the replacement subject as was allocated to the original subject e.g. R1006 is replaced by R1106, and receives the treatment originally allocated for R1006.
Each subject will be assigned to one of the three treatments, i.e. active Ampion(TM) (either combined with lidocaine/betamethasone or betamethasone suspension) or saline placebo combined with lidocaine/betamethasone. The allocation of treatment will be performed using a block randomization algorithm. Two sentinel subjects will be randomized to either of the treatment A (AmpionTrademark) with betamethasone/lidocaine) or the treatment C (saline with betamethasone/lidocaine).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
randomized, double-blin,placebo-controlled
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/06/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267356 0
Commercial sector/Industry
Name [1] 267356 0
Ampio Pharmaceuticals
Country [1] 267356 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Ampio Pharmaceuticals
Address
5445 DTC Parkway, Suite P4
Greenwood Village CO 80111
Country
United States of America
Secondary sponsor category [1] 266423 0
Commercial sector/Industry
Name [1] 266423 0
CPR Pharma Services
Address [1] 266423 0
Suite C 32 West Thebarton Rd
Thebarton SA 5031
Country [1] 266423 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269333 0
Calvary Health Care Adelaide Human Research & Ethics Committee (CHCA-HREC)
Ethics committee address [1] 269333 0
Ethics committee country [1] 269333 0
Australia
Date submitted for ethics approval [1] 269333 0
15/04/2011
Approval date [1] 269333 0
10/05/2011
Ethics approval number [1] 269333 0
Ethics committee name [2] 269334 0
Southern Adelaide Flinders Clinical Human Research Ethics Committee
Ethics committee address [2] 269334 0
Ethics committee country [2] 269334 0
Australia
Date submitted for ethics approval [2] 269334 0
20/06/2011
Approval date [2] 269334 0
Ethics approval number [2] 269334 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32816 0
Address 32816 0
Country 32816 0
Phone 32816 0
Fax 32816 0
Email 32816 0
Contact person for public queries
Name 16063 0
Vaughan Clift
Address 16063 0
Ampio Pharmaceuticals, Inc.
5445 DTC Parkway, Suite P4
Greenwood Village CO 80111
Country 16063 0
United States of America
Phone 16063 0
+1 303-418-1000
Fax 16063 0
+1 303-418-1001
Email 16063 0
vclift@ampiopharma.com
Contact person for scientific queries
Name 6991 0
Vaughan Clift
Address 6991 0
Ampio Pharmaceuticals, Inc.
5445 DTC Parkway, Suite P4
Greenwood Village CO 80111
Country 6991 0
United States of America
Phone 6991 0
+1 303-418-1000
Fax 6991 0
+1 303-418-1001
Email 6991 0
vclift@ampiopharma.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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