Phase 3 N=372 Randomized Double-blind Treatment

A 13-Week, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Postherpetic Neuralgia

Neuralgia, Postherpetic

Bottom Line

View on ClinicalTrials.gov: NCT00394901 ↗

Enrolled (actual)

372

Serious AEs

3.5%

Results posted

Feb 2009

Primary outcome: Primary: Mean Pain Scores at Endpoint — 5.12; 4.81; 4.26; 4.49 score on scale — p=0.262

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Placebo (Drug); Pregabalin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Primary completion: Nov 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Pain Scores at Endpoint	5.12; 4.81; 4.26; 4.49	0.262
PRIMARY Mean Pain Score at Endpoint by Groups of Subjects With Expected Similar Plasma Concentrations	4.99; 4.35; 4.34	0.016 sig
PRIMARY Number of Responders	15; 21; 32; 30	0.1160
PRIMARY Mean Pain Scores at Week 1	5.96; 5.45; 5.21; 5.23	0.038 sig
PRIMARY Mean Pain Scores at Week 2	5.75; 5.27; 4.76; 4.73	0.048 sig
PRIMARY Mean Pain Scores at Week 3	5.59; 5.18; 4.63; 4.60	0.096
PRIMARY Mean Pain Scores at Week 4	5.43; 5.14; 4.57; 4.50	0.227
PRIMARY Mean Pain Scores at Week 5	5.29; 5.15; 4.42; 4.55	0.577
PRIMARY Mean Pain Scores at Week 6	5.29; 5.02; 4.31; 4.54	0.275
PRIMARY Mean Pain Scores at Week 7	5.14; 4.90; 4.24; 4.48	0.334
PRIMARY Mean Pain Scores at Week 8	5.04; 4.89; 4.23; 4.47	0.530
PRIMARY Mean Pain Scores at Week 9	5.08; 4.87; 4.22; 4.50	0.392
PRIMARY Mean Pain Scores at Week 10	5.08; 4.86; 4.18; 4.56	0.364
PRIMARY Mean Pain Scores at Week 11	5.12; 4.88; 4.18; 4.47	0.326
PRIMARY Mean Pain Scores at Week 12	5.00; 4.71; 4.15; 4.37	0.241
PRIMARY Mean Pain Scores at Week 13	4.97; 4.70; 4.16; 4.36	0.281
SECONDARY Endpoint Sensory Scores of the Short-Form McGill Pain Questionnaire	8.97; 8.42; 7.11; 6.97	0.505
SECONDARY Endpoint Affective Scores of the Short-Form McGill Pain Questionnaire	2.43; 2.14; 1.72; 1.82	0.349
SECONDARY Endpoint Total Scores of the Short-Form McGill Pain Questionnaire	11.39; 10.56; 8.84; 8.78	0.441
SECONDARY Endpoint Visual Analogue Scale Scores of the Short-Form McGill Pain Questionnaire	50.02; 47.80; 41.99; 42.59	0.470
SECONDARY Endpoint Present Pain Intensity Scores of the Short-Form McGill Pain Questionnaire	2.21; 2.01; 1.78; 1.90	0.178
SECONDARY Mean Sleep Interference Scores at Endpoint	3.20; 2.44; 2.39; 2.26	0.001 sig
SECONDARY Endpoint Medical Outcomes Study Sleep Scale Scores:Sleep Disturbance	31.99; 23.09; 23.75; 20.65	0.001 sig
SECONDARY Endpoint Medical Outcomes Study Sleep Scale Scores:Snoring	22.28; 26.58; 25.24; 31.99	0.245
SECONDARY Endpoint Medical Outcomes Study Sleep Scale Scores:Awaken Short of Breath or With Headache	5.99; 6.70; 6.70; 4.95	0.760
SECONDARY Endpoint Medical Outcomes Study Sleep Scale Scores:Quantity of Sleep	6.58; 6.59; 6.85; 6.79	0.955
SECONDARY Endpoint Medical Outcomes Study Sleep Scale Scores:Sleep Adequacy	63.37; 67.38; 73.67; 69.37	0.296
SECONDARY Endpoint Medical Outcomes Study Sleep Scale Scores:Somnolence	30.23; 34.16; 41.45; 44.46	0.191
SECONDARY Endpoint Medical Outcomes Study Sleep Scale Scores:Overall Sleep Problem Index	29.22; 25.19; 26.03; 26.78	0.061
SECONDARY Endpoint Medical Outcomes Study Sleep Scale: Number of Participants With Optimal Sleep	37; 26; 48; 44	0.2842
SECONDARY Endpoint Patient Global Impression Change	3.6; 3.3; 2.9; 3.0	0.0466 sig
SECONDARY Endpoint Clinical Global Impression Change	3.3; 3.1; 2.7; 2.7	0.3440
SECONDARY Endpoint Short-Form 36-Item Health Survey Scores: Physical Functioning	76.16; 79.68; 76.93; 77.20	0.057
SECONDARY Endpoint Short-Form 36-Item Health Survey Scores: Role Limitations-Physical	67.96; 77.35; 74.63; 69.42	0.004 sig
SECONDARY Endpoint Short-Form 36-Item Health Survey Scores: Bodily Pain	47.47; 48.09; 54.54; 52.50	0.811
SECONDARY Endpoint Short-Form 36-Item Health Survey Scores: General Health Perception	52.36; 57.66; 56.19; 56.30	0.013 sig
SECONDARY Endpoint Short-Form 36-Item Health Survey Scores: Social Functioning	75.28; 77.71; 82.69; 77.11	0.443
SECONDARY Endpoint Short-Form 36-Item Health Survey Scores: Role Limitations-Emotional	69.99; 76.14; 75.41; 73.02	0.075
SECONDARY Endpoint Short-Form 36-Item Health Survey Scores: Vitality	54.16; 59.80; 61.58; 58.31	0.039 sig
SECONDARY Endpoint Short-Form 36-Item Health Survey Scores: Mental Health	61.91; 65.90; 68.90; 66.67	0.154
SECONDARY Number of Patients Not Reporting Allodynia	65; 52; 63; 66	0.6451
SECONDARY Number of Patients Not Reporting Hyperalgesia	66; 55; 66; 65	0.0732
SECONDARY Mean Sleep Interference Scores at Week 1	3.79; 3.00; 2.97; 2.81	—
SECONDARY Mean Sleep Interference Scores at Week 2	3.56; 2.89; 2.76; 2.49	—
SECONDARY Mean Sleep Interference Scores at Week 3	3.50; 2.81; 2.60; 2.43	—
SECONDARY Mean Sleep Interference Scores at Week 4	3.35; 2.79; 2.54; 2.36	—
SECONDARY Mean Sleep Interference Scores at Week 5	3.26; 2.74; 2.39; 2.41	—
SECONDARY Mean Sleep Interference Scores at Week 6	3.24; 2.63; 2.37; 2.33	—
SECONDARY Mean Sleep Interference Scores at Week 7	3.19; 2.55; 2.36; 2.21	—
SECONDARY Mean Sleep Interference Scores at Week 8	3.10; 2.49; 2.30; 2.14	—
SECONDARY Mean Sleep Interference Scores at Week 9	3.17; 2.44; 2.38; 2.22	—
SECONDARY Mean Sleep Interference Scores at Week 10	3.16; 2.46; 2.39; 2.28	—
SECONDARY Mean Sleep Interference Scores at Week 11	3.16; 2.43; 2.37; 2.27	—
SECONDARY Mean Sleep Interference Scores at Week 12	3.06; 2.36; 2.28; 2.21	—
SECONDARY Mean Sleep Interference Scores at Week 13	3.08; 2.33; 2.27; 2.19	—

Summary

The purpose of this study is to evaluate efficacy and safety of pregabalin in the treatment of postherpetic neuralgia in a dose-ranging manner.

Eligibility Criteria

Inclusion Criteria

Visual Analogue Scale (VAS) of pain is higher than 40 mm.
Pain is sustained for more than 3 months after healing of herpes zoster skin rash.

Exclusion Criteria

Malignancy within the past 2 years.
Patients who have undergone neurolytic or neurosurgical therapy for postherpetic neuralgia.
Creatinine clearance </= 30 mL/min (estimated from serum creatinine, body weight, age, and sex using the Cockcroft and Gault equation, by omitting any decimal fractions).
Patients having other severe pain which may impair the self assessment of the pain due to postherpetic neuralgia.
Skin conditions in the affected dermatome that could alter sensation.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00394901). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.