Clinical Trial Results:
Pain management in osteoarthritis using the centrally acting analgesics duloxetine and pregabalin
|
Summary
|
|
EudraCT number |
2011-003803-39 |
Trial protocol |
GB |
Global end of trial date |
27 Oct 2016
|
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
20 Nov 2019
|
First version publication date |
20 Nov 2019
|
Other versions |
|
Summary report(s) |
Journal of Pain Research Article |
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 |
11.0126
|
||
|
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
|
Sponsors
|
|||
Sponsor organisation name |
St Georges University of London
|
||
Sponsor organisation address |
Cranmer Terrace, London, United Kingdom, SW17 0RE
|
||
Public contact |
Joint Research and Enterprise Service, St George's University of London, 44 02087254986, sponsor@sgul.ac.uk
|
||
Scientific contact |
Prof Nidhi Sofat, St George's University of London, 44 02087250042, nsofat@sgul.ac.uk
|
||
|
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 |
10 Nov 2016
|
||
Is this the analysis of the primary completion data? |
Yes
|
||
Primary completion date |
27 Oct 2016
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
27 Oct 2016
|
||
Was the trial ended prematurely? |
No
|
||
|
General information about the trial
|
|||
Main objective of the trial |
The proposed study is based on the hypothesis that pain in hand osteoarthritis is due to local changes in the joint and the switching on of pain pathways in the brain that mediate chronic pain. The overall aim of this study is to determine whether drugs which influence central brain pain processing pathways can improve pain management in hand osteoarthritis. The primary objective of this study is to determine the effects of centrally acting drugs duloxetine and pregabalin versus placebo on pain perception in hand osteoarthritis using clinical pain scores.
|
||
Protection of trial subjects |
Interim analysis will not be completed due to the small size of the study.
Although duloxetine and pregabalin are already known to be safe, there is also the possibility of drug intolerance
and/or side effects. Participants will be provided with a helpline phone number to discuss any concerns or queries
regarding the study. They will also be given diary cards to record their experiences during the trial.
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Aug 2012
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
|
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
United Kingdom: 65
|
||
Worldwide total number of subjects |
65
|
||
EEA total number of subjects |
65
|
||
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) |
35
|
||
From 65 to 84 years |
30
|
||
85 years and over |
0
|
||
|
|||||||||||
|
Recruitment
|
|||||||||||
Recruitment details |
- | ||||||||||
|
Pre-assignment
|
|||||||||||
Screening details |
- | ||||||||||
|
Pre-assignment period milestones
|
|||||||||||
Number of subjects started |
65 | ||||||||||
Number of subjects completed |
65 | ||||||||||
|
Period 1
|
|||||||||||
Period 1 title |
Overall trial (overall period)
|
||||||||||
Is this the baseline period? |
Yes | ||||||||||
Allocation method |
Randomised - controlled
|
||||||||||
Blinding used |
Double blind | ||||||||||
Roles blinded |
Subject, Investigator | ||||||||||
|
Arms
|
|||||||||||
|
Arm title
|
Trial treatment | ||||||||||
Arm description |
- | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
Pregabalin
|
||||||||||
Investigational medicinal product code |
|||||||||||
Other name |
|||||||||||
Pharmaceutical forms |
Tablet
|
||||||||||
Routes of administration |
Oral use
|
||||||||||
Dosage and administration details |
150mg od week 1, increased to 150mg bd weeks 2-11, reduced to 150mg od week 12
|
||||||||||
Investigational medicinal product name |
Duloxetine
|
||||||||||
Investigational medicinal product code |
|||||||||||
Other name |
|||||||||||
Pharmaceutical forms |
Tablet
|
||||||||||
Routes of administration |
Oral use
|
||||||||||
Dosage and administration details |
30mg od week 1, increased to 30 mg bd weeks 2-11, reduced to 30mg od week 12
|
||||||||||
Investigational medicinal product name |
Placebo
|
||||||||||
Investigational medicinal product code |
|||||||||||
Other name |
|||||||||||
Pharmaceutical forms |
Tablet
|
||||||||||
Routes of administration |
Oral use
|
||||||||||
Dosage and administration details |
1 capsule per day week 1, increased to 1 capsule bd weeks 2-11 reduced to 1 capsule daily week 12
|
||||||||||
|
|||||||||||
|
|||
|
|||
|
End points reporting groups
|
|||
Reporting group title |
Trial treatment
|
||
Reporting group description |
- | ||
|
|||||||||
End point title |
Change in Visual Analogue Score (VAS) for pain [1] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Completion of the study, the change in VAS from baseline to 13 weeks will be used as the primary clinical endpoint for each participant.
|
||||||||
| 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: These are provided in the trial publication. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||
|
Adverse events information [1]
|
|||
Timeframe for reporting adverse events |
Collection, recording and reporting of AEs (including serious and non-serious events and reactions) to the Sponsor will be done according to the Sponsor within 24hrs of PI becoming aware
|
||
Assessment type |
Systematic | ||
|
Dictionary used for adverse event reporting
|
|||
Dictionary name |
MedDRA | ||
Dictionary version |
0
|
||
| 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: Adverse Event data can be found in the publication article. |
|||
|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
08 Jun 2012 |
Substantial amendment 01; 08 June 2012
Sponsor representative changed
Both handedness included. Clarification of inclusion #5.
Removal of dominant left hand and clarification of exclusion #10 as eGFR <60ml/min.
Clarification of recent surgery and implants timeframe.
Clarification of concomitant medication.
Addition of hepatic impairment exclusion criteria in exclusion criteria #11.
Clarification of maximum units of alcohol for females and males in exclusion criteria #14
Clarification of dose escalation from week 2 to week 11 and dose reduction on week 12.
Also clarified in section 11.4 of protocol in the similar manner.
Clarification of text to state that all SAEs will be reported.
|
||
06 Dec 2012 |
Substantial Amendment 02; dated 06th December 2012
Clarification of exclusion critieria 12 and 13 to state uncontrolled ischaemic heart disease and diabetes mellitus
Addition of sub study into secondary objective to include MRI scanning pre and post treatment at baseline and Week 13 for up to 18 participants
Addition of baseline assessments to include MRI scanning
Addition of subsequent assessments to include MRI scanning
Clarification to state hand x rays are part of routine clinical care
Addition to declaration of end of trial
Addition of MRI to secondary endpoints.
Schedule of study assessments updated with MRI scans
Addition of MRI scan to PIS
|
||
07 Jun 2013 |
Substantial amendment 3 dated 7 June 2013
Additional documents to increase study publicity.
- GP practice mail out letters to potential participants
- Patient mail-out letters
- Posters
|
||
06 Aug 2013 |
Substantial Amendment 4-
Amendment date: 06 August 2013
In order for patients to maximize the benefits of partaking in the study, as well as being able to measure a significant change in the patient's pain perception; we aim to recruit participants with a VAS score equal to 5/10 or above |
||
07 Nov 2014 |
Amendment number:
5
Amendment date:
07 November 2014
Following patient drop outs and expiration of 1st IMP batch- 2nd batch manufactured to allow replacement and where IMP stock allow increased patient recruitment (increase study power) Also it has been suggested that MRI control scans of healthy volunteers without OA should be collected for comparison
Correction in definition in line with new recruitment intentions
Updated to reflect intention to extend recruitment to facilitate replacement of drop-outs and also to add rationale for inclusion of healthy non-OA MRI brain controls
To reflect updated study participants
Brand new document for MRI healthy volunteer non-OA brain controls
|
||
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 | |||
