Abstract | OBJECTIVE: To evaluate the safety and efficacy of a once-daily gastroretentive formulation of gabapentin (G-GR; 1800 mg). METHODS: This was an 11-week, double-blind, randomized, placebo-controlled Phase 3 clinical trial in patients with postherpetic neuralgia. Patients underwent a 2-week dose titration, 8 weeks of stable dosing, and 1 week of dose tapering. The primary endpoint was the change in average daily pain intensity score from Baseline to Week 10 using Baseline Observation Carried Forward (BOCF) imputation. RESULTS: Four-hundred and fifty-two patients (mean age 65.6 y, BMI 29 Kg/m) were randomized. Baseline average daily pain intensity score during the week prior to randomization was 6.6 and 6.5 for the G-GR and placebo treatment groups, respectively. Three hundred and seventy-seven patients completed the study (84% G-GR, 83% placebo). G-GR significantly reduced BOCF change in average daily pain intensity compared with placebo (-2.1 vs. -1.6; G-GR vs. placebo, P=0.013). Compared with placebo, more G-GR-treated patients reported "much" or "very much" improvement (patient global impression of change, 43% vs. 34%; P<0.0434), and G-GR reduced sleep interference (-2.3 vs. -1.59; P<0.0001), although neither endpoint was considered statistically significant based on a stringent hierarchical statistical paradigm. Other secondary endpoints showed similar trends. The most common adverse events were dizziness (G-GR, 11.3% vs. placebo, 1.7 %) and somnolence (G-GR, 5.4% vs. placebo, 3.0%). CONCLUSION:
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Authors | Christine N Sang, Rekha Sathyanarayana, Michael Sweeney, DM-1796 Study Investigators |
Journal | The Clinical journal of pain
(Clin J Pain)
Vol. 29
Issue 4
Pg. 281-8
(Apr 2013)
ISSN: 1536-5409 [Electronic] United States |
PMID | 22801243
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Amines
- Analgesics
- Cyclohexanecarboxylic Acids
- Delayed-Action Preparations
- gamma-Aminobutyric Acid
- Gabapentin
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Amines
(administration & dosage, therapeutic use)
- Analgesics
(administration & dosage, therapeutic use)
- Cyclohexanecarboxylic Acids
(administration & dosage, therapeutic use)
- Delayed-Action Preparations
- Double-Blind Method
- Drug Administration Schedule
- Female
- Gabapentin
- Humans
- Male
- Middle Aged
- Neuralgia, Postherpetic
(drug therapy)
- Pain Measurement
- Severity of Illness Index
- Treatment Outcome
- gamma-Aminobutyric Acid
(administration & dosage, therapeutic use)
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