Clinical Trials Register

Summary
EudraCT Number:	2009-016766-86
Sponsor's Protocol Code Number:	A0081224
National Competent Authority:	Slovakia - SIDC (Slovak)
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2011-04-28
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Slovakia - SIDC (Slovak)

A.2

EudraCT number

2009-016766-86

A.3

Full title of the trial

A PHASE 3 DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, SAFETY AND EFFICACY STUDY OF ONCE DAILY CONTROLLED RELEASE PREGABALIN IN THE TREATMENT OF PATIENTS WITH POSTHERPETIC NEURALGIA (PROTOCOL A0081224)

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A Phase 3 double-blind, randomized, placebo-controlled, safety and efficacy study of once daily controlled release pregabalin in the treatment of patients with postherpetic neuralgia

A.3.2

Name or abbreviated title of the trial where available

Controlled Release Lyrica vs. Placebo for patients with PHN

A.4.1

Sponsor's protocol code number

A0081224

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT01270828

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Pfizer Inc, 235 East 42nd Street, New York, NY 10017
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Pfizer Inc
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Pfizer Inc
B.5.2	Functional name of contact point	Clinical Trials.gov Call Center
B.5.3	Address:
B.5.3.1	Street Address	235 East 42nd Street
B.5.3.2	Town/ city	New York
B.5.3.3	Post code	NY 10017
B.5.3.4	Country	United States
B.5.4	Telephone number	0018007181021
B.5.5	Fax number	001303739 1119
B.5.6	E-mail	ClinicalTrials.gov_inquiries@pfizer.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.2	Product code	PD-144,723
D.3.4	Pharmaceutical form	Prolonged-release tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Pregabalin
D.3.9.1	CAS number	148553-50-8
D.3.9.3	Other descriptive name	N/A
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	82.5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.2	Product code	PD-144,723
D.3.4	Pharmaceutical form	Prolonged-release tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Pregabalin
D.3.9.1	CAS number	148553-50-8
D.3.9.3	Other descriptive name	N/A
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	165
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.2	Product code	PD-144,723
D.3.4	Pharmaceutical form	Prolonged-release tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Pregabalin
D.3.9.1	CAS number	148553-50-8
D.3.9.3	Other descriptive name	N/A
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	330
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

postherpetic neuralgia

E.1.1.1

Medical condition in easily understood language

Post Herpetic Neuralgia

E.1.1.2

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	PT
E.1.2	Classification code	10036376
E.1.2	Term	Post herpetic neuralgia
E.1.2	System Organ Class	10029205 - Nervous system disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

• To evaluate the efficacy of pregabalin CR compared with placebo in the durability of effect for the treatment of pain associated with PHN among patients who initially respond to single-blind pregabalin.

E.2.2

Secondary objectives of the trial

• To evaluate the efficacy of pregabalin CR compared with placebo to relieve pain and to improve global assessment, functional status, and sleep.
• To assess treatment satisfaction with pregabalin CR compared with placebo.
•To assess the safety and tolerability of the pregabalin CR formulation.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
2. Male or female of any race, at least 18 years of age, and using appropriate methods of contraception. Women of childbearing potential must have a confirmed negative serum pregnancy test prior to enrollment.
3. Patients must have pain present for more than 3 months after the healing of the herpes zoster skin rash.
4. At screening (V1) and enrollment (V2), patients must have a score of ≥4 on the Pain Numeric Rating Scale (1-week recall period).
5. At enrollment (V2), at least 4 pain diaries must be completed satisfactorily within the last 7 days and the average pain score must be ≥4.
6. Subjects who are willing and able to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures

E.4

Principal exclusion criteria

1. Patients having other severe pain that may confound assessment or self-evaluation of the pain due to PHN.
2. Neurolytic or neurosurgical therapy for PHN.
3. Skin conditions in the affected dermatome that could alter sensation.
4. Creatinine clearance ≤30 mL/min (estimated from serum creatinine).
5. Have failed pregabalin treatment due to lack of efficacy, have hypersensitivity or
intolerance to pregabalin or other α2δ ligands (eg, gabapentin), or participated in a
pregabalin clinical trial. Patients previously taking pregabalin IR may be eligible if
they do not meet these exclusions.
6. Pregabalin use in the last 30 days. Subjects taking pregabalin in the last 30 days
should be washed out of pregabalin for at least 30 days prior to screening visit.
7. Use of prohibited medications in the absence of appropriate washout periods.
8. Participation in any clinical trial within the 30 days prior to screening and/or during
study participation.
9. Subjects with any clinically unstable cardiovascular, hematological, autoimmune,
endocrine, renal, hepatic, retinal or gastrointestinal disease.
10. Any subject considered at risk of suicide or self harm based on investigator
judgment and/or the results of a risk assessment.
11. Screening electrocardiogram (ECG) with any clinically significant abnormality.
12. Subjects with a history of life-threatening neoplasms within 5 years prior to study
entry, other than carcinoma in situ of the cervix or basal cell carcinoma of the skin.
13. Subjects with active gastrointestinal (GI) disease including any GI surgery that in
the opinion of the investigator would interfere with the absorption of study
medication. Conditions such as irritable bowel syndrome (IBS) are not excluded.
14. Subjects with difficulties swallowing tablets or unable to tolerate oral medication.
15. Platelet count <100x10 to the power of 9/L; white blood cell (WBC) count
<2.5x10to the power of 9/L; neutrophil count <1.5x10to the power of 9/L.
16. Clinically significant liver disease which may prevent the patient from completing
the study, or an elevation in aspartate aminotransferase (AST) or alanine
aminotransferase (ALT) of greater than 3 times the maximum value of the laboratory
assay normal range, or an elevation in total bilirubin of greater than 2 times the
maximum value of the laboratory assay normal range. Laboratory assays may be
repeated once, prior to enrollment, to confirm the unacceptability of any patient.
17. Alcohol or substance abuse or dependence within the previous year.
18. Are pregnant, nursing, or intend to become pregnant during the course of the
study.
19. Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration or may interfere with the interpretation of
study results and, in the judgment of the investigator, would make the subject
inappropriate for entry into this study.

E.5 End points

E.5.1

Primary end point(s)

• The sample size has been chosen in order to achieve 90% power to detect a difference in the primary endpoint, time to loss of therapeutic response (LTR), defined as 1) <30% pain response relative to the single blind baseline phase or 2) patient discontinuation due to lack of efficacy or adverse events during the double-blind phase of the study.

E.5.1.1

Timepoint(s) of evaluation of this end point

LTR during 13 weeks-double blind period

E.5.2

Secondary end point(s)

 A secondary LTR endpoint will be defined as the 5 day rolling average during DB, compared to the 5 day randomization baseline pain score. The endpoint will be defined as: 1. at least a 30% increase in the 5 days mean pain score during DB relative to the 5-day randomization baseline pain score ; and 2. a 5 days mean pain score ≥4. Subjects who discontinue due to lack of efficacy or adverse events in the double blind phase of the study will also be counted as an LTR. Time to LTR will be defined as the number of days from randomization to the date of the 5 Days LTR, or the date of discontinuation due to lack of efficacy or adverse events, whichever comes first.
 Pain numeric rating scale (NRS); 1 week recall period.
 Medical Outcomes Study (MOS)-Sleep Scale total score and each sub-domain.
 Patient Global Impression of Change (PGIC).
 Short Form 36 Health Survey (SF-36).
 Daily sleep interference diary.
 Hospital Anxiety and Depression Scale (HADS).
 Brief Pain Inventory (BPI-sf).
 Benefit, Satisfaction, Willingness to Continue Measure (BSW).

E.5.2.1

Timepoint(s) of evaluation of this end point

Efficacy: Pain NRS (Visit 1,2,7, &10), MOS (Visit 2,7,&10), PGIC (Visit 7 &10), SF-36( Visit 2,7,& 10), Daily Sleep Interference Diary (Visit 1,2,3,4,5,6,7,8,9, &10), HADS (Visit 2, 7, &10), BPI-sf (Visit 2,7, &10), BSW (Visit 7 &10) Safety: Adverse Events (Visit 1,2,3,4,5,6,7.8.9.10,&11), Physical & neurological examinations, weight and edema assessments and vital signs (Visit 1,7, &10), Suicidality assessments (Visit 1,2,3,4,5,6,7,8,9,10,&11)

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Tolerability

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Randomised withdrawal design

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Serbia

Bulgaria

Colombia

Croatia

Czech Republic

Denmark

Germany

Hong Kong

Hungary

India

Sweden

Poland

Russian Federation

Singapore

Slovakia

South Africa

Taiwan

Ukraine

United States

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

End of Trial in a Member State of the European Union is defined as the time at which it is deemed that sufficient subjects have been recruited and completed the study as stated in the
regulatory application and ethics application in the Member State. Poor recruitment by a Member State is not a reason for premature termination but is considered a normal conclusion to the study in that Member State.

End of Trial in all participating countries is defined as the last subject's last visit.

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

560

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

240

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

265

F.4.2.2

In the whole clinical trial

800

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

We expect that investigators will make a decision about the patients PHN treatment after the study. The protocol does not include any treatment beyond the subject’s participation in the study.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2011-05-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-04-28

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-09-03

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