Clinical Trial Results:
A 6-MONTH, OPEN-LABEL, SAFETY TRIAL OF PREGABALIN IN ADOLESCENT PATIENTS WITH FIBROMYALGIA
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Summary
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EudraCT number |
2010-020300-29 |
Trial protocol |
CZ |
Global end of trial date |
01 Jun 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
24 Feb 2016
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First version publication date |
24 Feb 2016
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Other versions |
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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 |
A0081231
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01020526 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Pfizer, Inc.
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Sponsor organisation address |
235 East 42nd Street, New York, NY, United States, 10017
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Public contact |
Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., +1 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
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Scientific contact |
Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., +1 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
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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? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
24 Sep 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
01 Jun 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
01 Jun 2015
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To evaluate the safety of pregabalin at doses of 75-450 mg/day (taken in twice daily [BID] doses) in participants who participated in the double-blind fibromyalgia study A0081180 and who wished to receive open-label pregabalin therapy.
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Protection of trial subjects |
The study was conducted in accordance with the protocol, legal and regulatory requirements, as well as the general principles set forth in the International Ethical Guidelines for Biomedical Research Involving Human Subjects (Council for International Organizations of Medical Sciences 2002), Guidelines for Good Clinical Practice (GCP) (International Conference on Harmonization [ICH] 1996), and the Declaration of Helsinki (World Medical Association 1996 and 2008). In addition, the study was conducted in accordance with applicable local regulatory requirements and laws.
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Background therapy |
This study has no background medication therapy. | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Sep 2010
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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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 |
United States: 40
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Country: Number of subjects enrolled |
India: 20
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Country: Number of subjects enrolled |
Czech Republic: 3
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Worldwide total number of subjects |
63
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EEA total number of subjects |
3
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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) |
63
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
A total of 63 participants were screened and enrolled at 19 study centers in this open-label extension study to the parent double-blind randomized fibromyalgia study A0081180. | ||||||||||||||||||
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Pre-assignment
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Screening details |
Participants initiated dosing at 75 mg/day and their dose was optimized over a 3 week period, based on tolerability and response, to a dose of 75 mg/day, 150 mg/day, 300 mg/day or 450 mg/day. | ||||||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||||
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Arms
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Arm title
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Pregabalin | ||||||||||||||||||
Arm description |
Participants initiated dosing at 75 mg/day, and their dose was optimized over a 3 week period based on tolerability and response to a dose of 75 mg/day, 150 mg/day, 300 mg/day or 450 mg/day. These doses were administered during the subsequent flexible dosing phase for a period of 21 weeks. Pregabalin was administered orally as capsules. | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Lyrica
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule, hard
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Routes of administration |
Oral use
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Dosage and administration details |
75 mg/day to 450 mg/day
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Baseline characteristics reporting groups
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Reporting group title |
Pregabalin
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Reporting group description |
Participants initiated dosing at 75 mg/day, and their dose was optimized over a 3 week period based on tolerability and response to a dose of 75 mg/day, 150 mg/day, 300 mg/day or 450 mg/day. These doses were administered during the subsequent flexible dosing phase for a period of 21 weeks. Pregabalin was administered orally as capsules. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Pregabalin
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Reporting group description |
Participants initiated dosing at 75 mg/day, and their dose was optimized over a 3 week period based on tolerability and response to a dose of 75 mg/day, 150 mg/day, 300 mg/day or 450 mg/day. These doses were administered during the subsequent flexible dosing phase for a period of 21 weeks. Pregabalin was administered orally as capsules. | ||
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End point title |
Change from baseline in pain numeric rating scale by week [1] | ||||||||||||||||||||
End point description |
The weekly pain numeric rating scale (Weekly Pain NRS) consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate worse pain. Participants chose the number that best described the pain during the last week.
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End point type |
Primary
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End point timeframe |
Baseline, Weeks 3, 8, 16, 24 and Last Visit.
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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: No statistical analyses were planned for this primary endpoint |
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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 |
All adverse events were recorded from the time the participants had taken at least 1 dose of study drug through the last subject visit.
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Adverse event reporting additional description |
For summary purposes, adverse event investigator terms were converted to preferred terms using a standard system of classification (COSTART or MedDRA). Adverse events tabulations included summaries by body system or system organ class, by overall decreasing frequency and by maximum intensity.
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
18.0
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Reporting groups
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Reporting group title |
Pregabalin
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Reporting group description |
Participants initiated dosing at 75 mg/day and their dose was optimized over a 3 week period, based on tolerability and response, to a dose of 75 mg/day, 150 mg/day, 300 mg/day or 450 mg/day. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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31 Dec 2012 |
Updated Pfizer protocol template wording was implemented. Information regarding the importance of parent/guardian/caregiver involvement in overseeing subject participation, especially dosing, was added. |
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14 Mar 2014 |
The Columbia Suicide Severity Rating Scale (C-SSRS) was added as a required study assessment. |
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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. | |||
| None reported | |||
