Efficient assessment of efficacy in post-traumatic peripheral neuropathic pain patients: pregabalin in a randomized, placebo-controlled, crossover study

Figures & data

Figure 1 Schematic representation of the study design.

Abbreviations: BID, twice a day; V, visit; W, week.

Figure 2 Patient disposition.

Note: ^aNausea, abdominal pain.

Table 1 Patient demographics

Treatment sequence	Pregabalin–placebo (n = 13)	Placebo–pregabalin (n = 12)
Age (years)
Mean ± SD	50.2 ± 16.7	49.4 ± 11.8
Range	20–70	22–70
Male (n [%])	6 (46.15)	5 (41.66)
Race (n [%])
White	13 (100)	12 (100)
Primary diagnosis MedDRA (v 12.0) preferred term
Nerve injury	13	12
Baseline pain score, mean ± SD	6.03 ± 1.29	5.96 ± 0.88

Abbreviations: MedDRA, Medical Dictionary for Regulatory Activities; SD, standard deviation.

Figure 3 Mean baseline and endpoint pain scores by period and by treatment.

Table 2 Mean pain score results at the end of treatment using the full-analysis set and the per-protocol set

Population	Treatment	LS mean	Treatment difference (SE)	95% CI
Full-analysis set	Pregabalin	4.89	−0.81 (0.305)*	(−1.45 to −0.17)
	Placebo	5.70
Per-protocol	Pregabalin	4.68	−1.07 (0.362)**	(−1.84 to −0.31)
	Placebo	5.75

Notes: Primary endpoint: endpoint mean pain score – average of the last 7 days on treatment. Analysis of covariance on end of treatment, fixed effects of period and treatment, two baseline covariates, and random patient effect.

* P = 0.0152;

** P = 0.0087 (two-sided).

Abbreviations: CI, confidence interval; LS, least squares; SE, standard error.