postherpetic neuralgia MedDRA version: 15.1 Level: PT Classification code 10036376 Term: Post herpetic neuralgia System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Code: PD-144,723
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Pregabalin
CAS Number: 148553-50-8
Other descriptive name: N/A
Concentration unit: mg milligram(s)
Concentra
Sponsors
Pfizer Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: 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
Exclusion criteria
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 a2d 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • 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.;Secondary Objective: • 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.;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. ;Timepoint(s) of evaluation of this end point: LTR during 13 weeks-double blind period | — |
Secondary
| Measure | Time frame |
|---|---|
| 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).;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) | — |
Countries
Bulgaria, Colombia, Croatia, Czech Republic, Denmark, Germany, Hong Kong, Hungary, India, Poland, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Sweden, Taiwan, Ukraine, United States
Contacts
Public ContactClinical Trials.gov Call Center
Pfizer Inc
Outcome results
None listed