Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000456550
Ethics application status
Approved
Date submitted
30/10/2006
Date registered
31/10/2006
Date last updated
26/10/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacodynamics and pharmacokinetics of subcutaneous doses of ACV1 in patients with neuropathic sciatic pain
Scientific title
A randomised, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacodynamics and pharmacokinetics of subcutaneous doses of ACV1 in patients with neuropathic sciatic pain
Secondary ID [1] 313 0
Metabolic Pharmaceuticals Ltd.: METACV102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neuropathic sciatic pain 1431 0
Condition category
Condition code
Neurological 1527 1527 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subcutaneous injections of 0.4mg/kg ACV1 once daily for 7 days, followed by a 7 day washout then crossover treatment
Intervention code [1] 1362 0
Treatment: Drugs
Comparator / control treatment
Subcutaneous injections of placebo once daily for 7 days, followed by a 7 day washout then crossover treatment
Control group
Placebo

Outcomes
Primary outcome [1] 2109 0
Safety and tolerability of ACV1
Timepoint [1] 2109 0
Pre dose laboratory testing days 1, 7, 15 and 21, and at exit evaluation day 30. Electrocardiogram (ECG) testing predose and 1 and 4 hours post dose on days 1, 7, 15 and 21, and at the exit evaluation on day 30
Primary outcome [2] 2110 0
Pharmacodynamic effects of ACV1 following single and multiple subcutaneous doses.
Timepoint [2] 2110 0
Touch sensitivity testing on days 1, 7, 15 and 21 predose and at 0.5, 1, 2, 4 and 8 hours post dose.
Primary outcome [3] 2111 0
Single and multiple dose subcutaneous pharmacokinetics of ACV1
Timepoint [3] 2111 0
Days 1, 7, 15 and 21 predose then 10, 15, 20, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 4, 6 and 8 hours post dose
Secondary outcome [1] 3650 0
N/A
Timepoint [1] 3650 0
Nil

Eligibility
Key inclusion criteria
1.Ability to provide written informed consent.2. Non child-bearing potential (surgically sterilised, hysterectomised or post-menopausal, determined as = 45 years of age and amenorrhea for > 12 months). 3.Neuropathic sciatic pain as evidenced by presence of moderate to severe spontaneous neuropathic pain (based on Visual Analogue Scale (VAS) = 4cm) pain in one or both buttocks or legs for 3 months or greater for at least 5 days a week plus at least one of the following;a.Sharp & shooting pain below the kneeb.Pain evoked by Straight Leg Raising (SLR) to 60 degrees or lessc.Decreased or absent ankle reflexes.Weakness of muscles below the kneee.Sensory loss in L5/S1 distribution (assessed by pinprick, light touch, vibration and joint movement. 4.If on concurrent medications for sciatic pain, medications and doses must have been stable for 4 weeks prior to Day 1. 5. Weight < 120 kg. 6.Adequate venous access in arms to allow collection of a number of blood samples. 7.Ability to read and understand English in order to complete the assessment scales.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Any history of clinically significant cardiac arrhythmias or the presence of clinically significant abnormalities on ECG at screening.2.Any evidence or history of hypotension or hypertension. Hypotension is defined as three separate readings that persistently read under 90/60 mmHg. Hypertension is defined as three separate readings that persistently read over 140/90 mmHg.3.Tumours or fractures as the cause of pain.4.Diabetes as defined as fasting blood glucose levels = 7mM.5.A history or evidence of any other clinical neuropathy.6.Diagnosed Rheumatoid Arthritis.7.Pain anywhere else of an equal or greater intensity than the sciatica-related pain.8.Admission for Heart Failure, a Myocardial Infarction, Transient Ischaemic Attack or Cerebrovascular Accident within the 6 months prior to Day 1.9.Patients with a clinical condition that may, in the opinion of the Investigator, impact on the patient’s ability to participate in the study, or on the study results10.A calculated creatinine clearance of less than 75 mL/min.11.Documented or reported history of Hepatitis B, Hepatitis C, or HIV infection. NOTE – these will not be tested for.12.Any evidence of organ dysfunction, or any deviation in clinical laboratory values which is confirmed on re-examination to be clinically significant (i.e. in the opinion of the Investigator would jeopardise the safety of the patient or impact on the validity of the study results), including a liver function test (LFT) > 1.5 x upper limit of normal (ULN). Total bilirubin levels > 1.5 x ULN will be allowed if associated with Gilbert’s syndrome.13.History of, or current evidence of, abuse (in the investigator’s opinion) of alcohol or any licit or illicit drug substance.14.Known poor compliers or those unlikely to attend study visits.15.Receipt of any drug as part of a research study within 30 days of Day 1.16.Standard blood donation (usually 550 mL) within the 12-week period prior to Day 1.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
All site and sponsor staff and all subjects will be blinded to the study, with the exception of the trial pharmacist who will prepare the drug in a manner that maintains the blinding for all other staff.
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/09/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1665 0
Commercial sector/Industry
Name [1] 1665 0
Metabolic Pharmaceuticals
Country [1] 1665 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Metabolic Pharmaceuticals
Address
509 St Kilda Rd Melbourne
Country
Australia
Secondary sponsor category [1] 1469 0
None
Name [1] 1469 0
N/A
Address [1] 1469 0
Country [1] 1469 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3107 0
Royal Adelaide Hospital
Ethics committee address [1] 3107 0
Ethics committee country [1] 3107 0
Australia
Date submitted for ethics approval [1] 3107 0
Approval date [1] 3107 0
Ethics approval number [1] 3107 0
060817

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

Contacts
Principal investigator
Name 27589 0
Address 27589 0
Country 27589 0
Phone 27589 0
Fax 27589 0
Email 27589 0
Contact person for public queries
Name 10551 0
Nicole Kruger
Address 10551 0
Metabolic Pharmaceuticals
Level 3
509 St Kilda Rd
Melbourne VIC 3004
Country 10551 0
Australia
Phone 10551 0
+61 3 98605700
Fax 10551 0
Email 10551 0
[email protected]
Contact person for scientific queries
Name 1479 0
Professor Guy Ludbrook
Address 1479 0
Department of Anaesthesia
Eleanor Harrald Building
Royal Adelaide Hospital
North Tce
Adelaide SA 5000
Country 1479 0
Australia
Phone 1479 0
+61 8 82225422
Fax 1479 0
Email 1479 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.