Clinical Trial Results:
A Multicenter, Randomized, Double-blind, Placebo- and Active-Controlled Study Comparing the Safety and Analgesic Efficacy of ABT-110 to Placebo in Subjects with Chronic Low Back Pain
Summary
|
|
EudraCT number |
2011-002143-95 |
Trial protocol |
NO PL IT FI |
Global end of trial date |
19 Dec 2012
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
20 Apr 2016
|
First version publication date |
09 Jul 2015
|
Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
Trial identification
|
|||
Sponsor protocol code |
M12-141
|
||
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
|
|||
Sponsor organisation name |
AbbVie Deutschland GmbH & Co. KG
|
||
Sponsor organisation address |
Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, United Kingdom, SL6 4XE
|
||
Public contact |
Global Medical Information, AbbVie, 001 800-633-9110,
|
||
Scientific contact |
Jerry Hall, MD, AbbVie, jerry.hall@abbvie.com
|
||
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
19 Dec 2012
|
||
Is this the analysis of the primary completion data? |
No
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
19 Dec 2012
|
||
Was the trial ended prematurely? |
Yes
|
||
General information about the trial
|
|||
Main objective of the trial |
The primary objective for this study is to compare the safety, tolerability and the analgesic efficacy of ABT-110 administered subcutaneously (SC) once every 8 weeks (q8w) for a total of two doses to placebo in subjects with chronic low back pain (CLBP).
One subject was enrolled into the study prior to the study being prematurely discontinued by the Sponsor based on a strategic business decision. No statistical, pharmacokinetic or pharmacogenetic analyses were performed. Safety data are provided for the 1 subject who received placebo.
|
||
Protection of trial subjects |
Subject and/or legal guardian read and understood the information provided about the study and gave written permission.
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
13 Nov 2012
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
Yes
|
||
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
South Africa: 1
|
||
Worldwide total number of subjects |
1
|
||
EEA total number of subjects |
0
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
1
|
||
From 65 to 84 years |
0
|
||
85 years and over |
0
|
|
|||||||||||
Recruitment
|
|||||||||||
Recruitment details |
Approximately 330 subjects were planned to be enrolled. One subject was enrolled into the study prior to the study being prematurely discontinued by the Sponsor based on a strategic business decision. | ||||||||||
Pre-assignment
|
|||||||||||
Screening details |
One subject was enrolled and randomized to receive placebo. No subjects were randomized to ABT-110 (planned doses of 5, 10, 20, and 30 mg ABT-110) or naproxen (planned dose of 500 mg). | ||||||||||
Period 1
|
|||||||||||
Period 1 title |
Overall Study (overall period)
|
||||||||||
Is this the baseline period? |
Yes | ||||||||||
Allocation method |
Randomised - controlled
|
||||||||||
Blinding used |
Double blind | ||||||||||
Roles blinded |
Subject, Investigator, Monitor, Carer, Assessor | ||||||||||
Arms
|
|||||||||||
Arm title
|
Placebo | ||||||||||
Arm description |
Placebo for ABT-110 by subcutaneous (SC) injection every 8 weeks (q8w) for a total of 2 doses, and placebo for naproxen by capsule orally once daily (BID) for 16 weeks. | ||||||||||
Arm type |
Placebo | ||||||||||
Investigational medicinal product name |
Placebo for ABT-110
|
||||||||||
Investigational medicinal product code |
|||||||||||
Other name |
|||||||||||
Pharmaceutical forms |
Solution for injection
|
||||||||||
Routes of administration |
Subcutaneous use
|
||||||||||
Dosage and administration details |
Placebo for ABT-110 administered by subcutaneous injection
|
||||||||||
Investigational medicinal product name |
Placebo for naproxen
|
||||||||||
Investigational medicinal product code |
|||||||||||
Other name |
|||||||||||
Pharmaceutical forms |
Capsule, hard
|
||||||||||
Routes of administration |
Oral use
|
||||||||||
Dosage and administration details |
Placebo for naproxen administered orally as capsule
|
||||||||||
|
|
|
|||
End points reporting groups
|
|||
Reporting group title |
Placebo
|
||
Reporting group description |
Placebo for ABT-110 by subcutaneous (SC) injection every 8 weeks (q8w) for a total of 2 doses, and placebo for naproxen by capsule orally once daily (BID) for 16 weeks. |
|
|||||||||
End point title |
Change from Baseline to Week 16 in Subject's Assessment of Chronic Lower Back Pain (CLPB) Intensity by 100 mm Visual Analog Scale (VAS) [1] | ||||||||
End point description |
The change from the baseline visit to Week 16 in subject's assessment of pain intensity, assessed using the CLBP Intensity VAS (0 mm = No Pain and 100 mm = Worst Pain Imaginable).
|
||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Baseline Visit (prior to dosing on day of initial study drug administration) to Week 16
|
||||||||
Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Not analyzed due to study termination |
|||||||||
|
|||||||||
Notes [2] - not analyzed due to study termination |
|||||||||
No statistical analyses for this end point |
|
|||||||||||
Adverse events information [1]
|
|||||||||||
Timeframe for reporting adverse events |
Adverse events were collected from the time of study drug administration through follow up at Week 20 (20 weeks); serious adverse events were collected from the time that informed consent was obtained (24 weeks).
|
||||||||||
Adverse event reporting additional description |
All adverse events were collected whether solicited or spontaneously reported by the subject.
|
||||||||||
Assessment type |
Systematic | ||||||||||
Dictionary used for adverse event reporting
|
|||||||||||
Dictionary name |
MedDRA | ||||||||||
Dictionary version |
15.0
|
||||||||||
Reporting groups
|
|||||||||||
Reporting group title |
Placebo
|
||||||||||
Reporting group description |
Placebo for ABT-110 by subcutaneous (SC) injection every 8 weeks (q8w) for a total of 2 doses, and placebo for naproxen by capsule orally once daily (BID). | ||||||||||
|
|||||||||||
Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||
|
|||||||||||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: The study was terminated. No adverse events were reported for the 1 subject enrolled. |
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
27 Apr 2012 |
To change the low end of the tested dose range from 3 mg to 5 mg ABT-110 and to decrease the upper dose limit from 40 mg to 30 mg ABT-110; add additional post study drug administration monitoring; update safety and pharmacokinetic information because data was no longer preliminary; add description of study's anticipated benefits and risks; decrease the sample size from 390 (65 per arm) to 330 (55 per arm); revise inclusion and exclusion criteria to clarify criterion for duration of history of chronic low back pain and therapeutic dosing, add upper limit for BMI, increase threshold score for Mini-Mental Status Examination score, and exclude subjects with clinically significant allergy to medications used in study, history of rapidly progressive osteoarthritis, scoliosis surgery, osteoarthritis, or juvenile rheumatoid arthritis, or coronary artery bypass graft; provide additional detail regarding exclusionary treatment with corticosteroids, prohibited medications, or prior biologic therapy; clarify study procedures; clarify timing of efficacy measures; clarify role of the independent data monitoring committee; update adverse event definitions and management; and add interim efficacy and pharmacokinetic analyses. |
||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |