Phase 4 N=222 Randomized Double-blind Treatment

Pregabalin for Treatment of Patients With Postherpetic Neuralgia (PHN)

Postherpetic Neuralgia ( PHN )

Bottom Line

View on ClinicalTrials.gov: NCT01455428 ↗

Enrolled (actual)

222

Serious AEs

0.9%

Results posted

May 2015

Primary outcome: Primary: Baseline Mean Pain Score — 5.93; 6.08 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Lyrica (pregabalin) (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Primary completion: Jan 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Baseline Mean Pain Score	5.93; 6.08	—
PRIMARY Change From Baseline in Mean Pain Score at Endpoint	-1.81; -1.09	0.0002 sig
SECONDARY Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 8	-0.62; -0.12; -1.00; -0.35; -1.23; -0.65	0.0010 sig
SECONDARY Baseline Mean Sleep Interference Score	3.81; 4.54	—
SECONDARY Change From Baseline in Mean Sleep Interference Score at Endpoint	-1.24; -0.70	0.0079 sig
SECONDARY Change From Baseline in Weekly Mean Sleep Interference Scores at Weeks 1 to 8	-0.52; 0.01; -0.82; -0.16; -0.92; -0.35	0.0024 sig
SECONDARY Percentage of 30 Percent (%) Responders at Endpoint	52.3; 30.6	0.0007 sig
SECONDARY Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 3, 5, and 8	8.24; 8.00; -1.68; -0.29; -2.97; -1.05	—
SECONDARY Baseline Pain Visual Analogue Scale (VAS) and Present Pain Intensity (PPI) Scale	60.39; 62.60; 2.33; 2.42	—
SECONDARY Change From Baseline in Pain VAS From the SF-MPQ at Endpoint	-20.71; -12.53	<0.0001 sig
SECONDARY Change From Baseline in PPI Scale From the SF-MPQ at Endpoint	-0.79; -0.42	0.0007 sig
SECONDARY Baseline Medical Outcomes Study (MOS)-Sleep Scale Scores	36.09; 35.08; 29.19; 30.83; 9.91; 8.07	—
SECONDARY Change From Baseline in MOS-Sleep Scale, Sleep Disturbance Score at Endpoint	-11.97; -4.76	0.0039 sig
SECONDARY Change From Baseline in MOS-Sleep Scale, Snoring Score at Endpoint	-2.00; -3.73	0.5351
SECONDARY Change From Baseline in MOS-Sleep Scale, Awaken Short of Breath Score at Endpoint	-0.10; 0.26	0.8892
SECONDARY Change From Baseline in MOS-Sleep Scale, Quantity of Sleep Score at Endpoint	0.69; 0.25	0.0035 sig
SECONDARY Percentage of Participants Who Had Optimal Sleep at Endpoint	49.5; 40.6	0.0972
SECONDARY Change From Baseline in MOS-Sleep Scale, Sleep Adequacy Score at Endpoint	10.44; 8.64	0.5702
SECONDARY Change From Baseline in MOS-Sleep Scale, Somnolence Score at Endpoint	0.33; -0.54	0.6929
SECONDARY Change From Baseline in MOS-Sleep Scale, Sleep Problems Index Score at Endpoint	-7.38; -4.54	0.1403
SECONDARY Clinical Global Impression of Change (CGIC) Score at Endpoint	2.55; 3.18	<0.0001 sig
SECONDARY Patient Global Impression of Change (PGIC) Score at Endpoint	2.68; 3.17	<0.0001 sig
SECONDARY Baseline Hospital Anxiety and Depression Scale (HADS) Scores	3.22; 3.37; 3.45; 3.47	—
SECONDARY Change From Baseline in HADS Anxiety Total Score at Endpoint	-0.92; -0.71	0.5060
SECONDARY Change From Baseline in HADS Depression Total Score at Endpoint	-0.65; -0.55	0.7247

Summary

To prove pregabalin is effective in relieving pain compared with placebo in subjects with postherpetic neuralgia (PHN).

Eligibility Criteria

Inclusion Criteria

Male or female Chinese subjects, ages ≥18 at screening
Subjects with symptoms of neuropathic pain associated with postherpetic neuralgia (PHN). Subjects must have pain present for ﹥3 months after healing of the acute herpes zoster skin rash
At screening (V1), subjects must have a score ≥40mm on the 100-mm visual analog scale (VAS) of the Short Form-McGill Pain Questionnaire (SF-MPQ, see Appendix 3)
At randomization (V2), subjects must have a score ≥40mm on the 100-mm visual analog scale (VAS) of the Short Form-McGill Pain Questionnaire (SF-MPQ, see Appendix 3)
At randomization (V2), subjects must have completed at least 5 daily pain diaries (DPRS, see Appendix 2) and have an average daily pain score ≥4 over the past 7 days

Exclusion Criteria

Subjects who demonstrate a high response to placebo, with 30% decrease on the Pain Visual Analog Scale (VAS) at randomization as compared to screening
Subjects who have a high variability in pain scores during the 1 week screening period, with any difference between two scores ﹥3

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01455428). 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.