Phase 4 N=368 Randomized Quadruple-blind Treatment

P4 (Pregabalin for Peripheral Posttraumatic Pain)

Neuralgia

Bottom Line

View on ClinicalTrials.gov: NCT00292188 ↗

Enrolled (actual)

368

Serious AEs

—

Results posted

Oct 2009

Primary outcome: Primary: Weekly Mean Pain Score at End of Treatment (Week 8) From Daily Pain Diary — 4.61; 5.23 score on a scale — p=0.010

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: 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: May 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Weekly Mean Pain Score at End of Treatment (Week 8) From Daily Pain Diary	4.61; 5.23	0.010 sig
SECONDARY Hospital Anxiety and Depression Scale (HADS) Anxiety Score	6.52; 7.36	0.031 sig
SECONDARY Hospital Anxiety and Depression Scale (HADS) Depression Score	5.23; 6.20	0.003 sig
SECONDARY Hospital Anxiety and Depression Scale (HADS) Anxiety Score - FAS Subset With Moderate/Severe Baseline Scores	9.94; 11.63	0.099
SECONDARY Hospital Anxiety and Depression Scale (HADS) Depression Score - FAS Subset With Moderate/Severe Baseline Scores	12.04; 11.80	0.819
SECONDARY Weekly Mean Pain Score From Daily Pain Diary	5.54; 5.79; 5.37; 5.64; 4.91; 5.44	0.099
SECONDARY Number of Subjects With 30% and 50% Response in Weekly Mean Daily Pain Rating Score (DPRS) From Baseline Until Endpoint (Week 8)	50; 32; 30; 18	0.032 sig
SECONDARY Weekly Mean Sleep Interference Score	2.93; 3.73	0.001 sig
SECONDARY Medical Outcome Study (MOS) Sleep Subscales	35.73; 46.45; 38.92; 37.87; 14.71; 20.66	0.000 sig
SECONDARY Medical Outcome Study (MOS) Optimal Sleep	58; 45	0.267
SECONDARY Patient Global Impression of Change (PGIC)	13; 6; 27; 22; 41; 26	—
SECONDARY Clinical Global Impression of Change (CGIC)	11; 6; 33; 18; 36; 26	—
SECONDARY Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication	54.53; 53.60; 52.64; 42.56	—
SECONDARY Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication	50.33; 51.05; 62.36; 54.15	—
SECONDARY Pain Treatment Satisfaction Scale (PTSS): Medication Characteristics	57.44; 59.39; 71.52; 70.39	—
SECONDARY Pain Treatment Satisfaction Scale (PTSS): Efficacy	43.23; 42.73; 53.21; 37.88	—
SECONDARY Modified Brief Pain Inventory Short Form (m-BPI-sf)	4.57; 4.69; 3.31; 4.17; 5.36; 5.72	—
SECONDARY Neuropathic Pain Symptom Inventory (NPSI) Total Intensity Score	33.29; 37.12	0.090
SECONDARY Medical Outcome Study Cognitive Subscale (MOS-Cog); Reasoning	5; 1; 6; 15; 5; 15	—
SECONDARY Medical Outcome Study Cognitive Subscale (MOS-Cog); Concentration	4; 4; 8; 14; 13; 14	—
SECONDARY Medical Outcome Study Cognitive Subscale (MOS-Cog); Confusion	2; 6; 8; 12; 6; 7	—
SECONDARY Medical Outcome Study Cognitive Subscale (MOS-Cog); Memory	7; 10; 7; 14; 6; 8	—
SECONDARY Medical Outcome Study Cognitive Subscale (MOS-Cog); Attention	5; 3; 3; 16; 13; 14	—
SECONDARY Medical Outcome Study Cognitive Subscale (MOS-Cog); Thinking	2; 1; 6; 9; 3; 6	—
SECONDARY Davidson Trauma Scale (DTS): Severity	15.55; 17.83; 11.71; 15.43	—
SECONDARY Davidson Trauma Scale (DTS): Frequency	18.27; 20.90; 14.16; 18.47	—
SECONDARY Davidson Trauma Scale (DTS): Total Score	34.57; 38.76; 26.18; 33.62	—

Summary

To evaluate the efficacy of pregabalin compared to placebo in the treatment of posttraumatic peripheral neuropathic pain

Eligibility Criteria

Inclusion Criteria

Diagnosis of Posttraumatic Peripheral Neuropathic Pain (NeP) syndrome, including post-surgical NeP, NeP due to peripheral nerve injury, and phantom limb pain, confirmed by a qualified pain specialist and persisting for a minimum of 3 months following the traumatic event

Exclusion Criteria

Subjects whose posttraumatic neuropathic pain is due to Complex Regional Pain Syndrome (CRPS, Type I or Type II)
NeP not due to trauma, and not peripheral pain

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00292188). 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.