Clinical Trial Results:
An exploratory, randomized, double blind, placebo controlled, parallel groups Phase II clinical trial to evaluate the efficacy and safety of E-52862 (400 mg) by oral route, in patients with post-herpetic neuralgia (PHN).
Summary
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EudraCT number |
2012-000399-41 |
Trial protocol |
ES |
Global end of trial date |
27 Nov 2013
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Results information
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Results version number |
v1(current) |
This version publication date |
29 Jul 2016
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First version publication date |
29 Jul 2016
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
ESTEVE-SIGM-203
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
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WHO universal trial number (UTN) |
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Sponsors
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Sponsor organisation name |
Laboratorios Dr. Esteve. S.A. (ESTEVE)
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Sponsor organisation address |
Avda. Mare de Déu de Montserrat, 221, Barcelona, Spain, 08041
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Public contact |
Jesús Cebrecos. Study Medical Monitor, Laboratorios Dr. Esteve. S.A., +34 934466000, jcebrecos@esteve.es
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Scientific contact |
Jesús Cebrecos. Study Medical Monitor, Laboratorios Dr. Esteve. S.A. , +34 934466000, jcebrecos@esteve.es
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
20 Oct 2014
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
27 Nov 2013
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Global end of trial reached? |
Yes
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Global end of trial date |
27 Nov 2013
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
The primary objective of this study is to assess the analgesic efficacy of E-52862 in subjects with moderate to severe postherpetic neuralgia
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Protection of trial subjects |
The study has been conducted in compliance with the protocol, regulatory requirements, good
clinical practice (GCP) and the ethical principles of the latest revision of the Declaration of
Helsinki as adopted by the World Medical Association.
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Background therapy |
Subjects were treated with stable doses of gabapentin or pregabalin for at least one month prior to the screening visit, and continued taking the same doses for the duration of the study at the investigator’s criteria. | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
29 Nov 2012
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Spain: 13
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Worldwide total number of subjects |
13
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EEA total number of subjects |
13
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
2
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From 65 to 84 years |
11
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85 years and over |
0
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Recruitment
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Recruitment details |
The study was conducted in Spain, during 29-Nov-2012 ( FSFV) and 30-Oct-2013 (LSLV) | |||||||||
Pre-assignment
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Screening details |
Male and female adults with a diagnosis of moderate to severe pain of PHN for more than 3 months since the resolution of rash but no more than 5 years, treated with stable doses of gabapentin or pregabalin for at least 1 month prior to the screening, who were able to continue taking the same doses for the duration of the study at the IPs criteria | |||||||||
Period 1
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Period 1 title |
Overall Trial (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator, Monitor, Data analyst | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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E-52862 | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
E-52862
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
400 mg once a day
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Arm title
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Control | |||||||||
Arm description |
- | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
1 capsule of placebo once a day
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Baseline characteristics reporting groups
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Reporting group title |
E-52862
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Control
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Safety analysis set
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Subject analysis set type |
Safety analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
All randomised subjects who receive at least 1 dose of the study drug. Safety analysis will be performed
on the safety set.
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Subject analysis set title |
Full analysis set
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Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The Full Analysis Set (FAS) was defined as all randomized patients who took study medication and provided at least one valid baseline and one on-treatment observation for efficacy variables.
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End points reporting groups
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Reporting group title |
E-52862
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Reporting group description |
- | ||
Reporting group title |
Control
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Reporting group description |
- | ||
Subject analysis set title |
Safety analysis set
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
All randomised subjects who receive at least 1 dose of the study drug. Safety analysis will be performed
on the safety set.
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Subject analysis set title |
Full analysis set
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
The Full Analysis Set (FAS) was defined as all randomized patients who took study medication and provided at least one valid baseline and one on-treatment observation for efficacy variables.
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End point title |
NPRS – Average pain – change from baseline to day 28 [1] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Time specific change from baseline to day 28 in mean pain intensity in the previous 7 days interval measured by a Numerical Pain Rating Scale (NPRS), included in a patient diary (average 24 hour pain)
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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: Considering the final number of patients randomized, the content of the Statistical Analysis Plan (SAP) was updated taking into account this important issue and no statistical comparisons were performed. Strictly Confidential Information and Data. Property of ESTEVE. |
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No statistical analyses for this end point |
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End point title |
NPRS – Worst pain – change from baseline to day 28 | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Time specific change from baseline to day 28 in mean pain intensity in the previous 7 days interval measured by a Numerical Pain Rating Scale (NPRS), included in a patient diary (worst 24 hour pain)
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No statistical analyses for this end point |
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End point title |
NPRS – Average pain – change from baseline to day 7, 14 and 21 | |||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Time specific change from baseline to day 7, 14, and 21, in mean pain intensity in the previous 7 days interval measured by a Numerical Pain Rating Scale (NPRS), included in a patient diary (average 24 hour pain)
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No statistical analyses for this end point |
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End point title |
NPRS – Worst pain – change from baseline to day 7, 14 and 21 | |||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Time specific change from baseline to day 7, 14, and 21, in mean pain intensity in the previous 7 days
interval measured by a Numerical Pain Rating Scale (NPRS), included in a patient diary (worst 24 hour
pain)
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No statistical analyses for this end point |
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End point title |
Consumption of pain rescue medication | |||||||||||||||
End point description |
Number of patients that required pain rescue medication during the 28 days treatment period.
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End point type |
Secondary
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End point timeframe |
28 days treatment period
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
From the first IMP intake up to two weeks after the last IMP administration
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Adverse event reporting additional description |
Treatment Emergent Adverse Event are displayed. The AEs that occurred after the first IMP intake are going to be considered as treatment emergent AEs (TEAEs) either serious or not.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
16.1
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Reporting groups
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Reporting group title |
E-52862
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Reporting group description |
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Reporting group title |
Placebo
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Reporting group description |
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
Provided study patients could not be recruited at a reasonable rate, the sponsor prematurely terminated the study after a period of 12 months recruitment, with 13 patients randomized. Strictly Confidential Information and Data. Property of ESTEVE |