Enriched enrollment: definition and effects of enrichment and dose in trials of pregabalin and gabapentin in neuropathic pain. A systematic review.

Journal article

AIMS: Enriched enrollment study designs have been suggested to be useful for proof of concept when only a proportion of the diseased population responds to a treatment intervention. We aim to investigate whether this really is the case in trials of pregabalin and gabapentin in neuropathic pain. METHODS: We defined 'complete', 'partial' and 'non-enriched' enrollment, and examined pregabalin and gabapentin trials for the extent of enrichment and for effects of enrichment on efficacy and advers...

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Authors: Straube, S; Derry, S; McQuay, H; Moore, R

• Publication status: Published
• Journal: British journal of clinical pharmacology
• Volume: 66
• Issue: 2
• Pages: 266-275
• Publication date: 2008-08-01
• DOI: 10.1111/j.1365-2125.2008.03200.x
• EISSN: 1365-2125
• ISSN: 0306-5251
• Language: English
• Keywords: Humans; Dose-Response Relationship, Drug; Treatment Outcome; Analgesics; Neuralgia; Cyclohexanecarboxylic Acids; Amines; Randomized Controlled Trials as Topic; gamma-Aminobutyric Acid