Early phase drug development for treatment of chronic pain - Options for clinical trial and program design

Contemporary Clinical Trials

Volumn 33, Issue 4, 2012, Pages 689-699

  Kalliomäki, Jarkko ^a   Miller, Frank ^a   Kågedal, Matts ^a   Karlsten, Rolf ^a  

^a ASTRAZENECA R AND D   (Sweden)

Author keywords

Adaptive dosing; Chronic pain; Clinical trial; Dose titration; Drug development; Enriched enrolment

Indexed keywords

ANALGESIC AGENT; AZD 1386; GABAPENTIN; NONSTEROID ANTIINFLAMMATORY AGENT; PLACEBO; PREGABALIN; UNCLASSIFIED DRUG; VANILLOID RECEPTOR 1 ANTAGONIST;

BAYES THEOREM; CHRONIC PAIN; CROSSOVER PROCEDURE; DOSE RESPONSE; DRUG DEVELOPMENT; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG TOLERANCE; FOOD AND DRUG ADMINISTRATION; HUMAN; NEUROPATHIC PAIN; OPEN STUDY; OSTEOARTHRITIS; PHARMACODYNAMICS; PHARMACOKINETICS; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); POPULATION; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SAMPLE SIZE; SIMULATION; STUDY DESIGN;

ANALGESICS; CHRONIC PAIN; CLINICAL TRIALS, PHASE II AS TOPIC; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; HUMANS; PATIENT SELECTION; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN;

EID: 84861530688     PISSN: 15517144     EISSN: 15592030     Source Type: Journal    
DOI: 10.1016/j.cct.2012.02.013     Document Type: Review

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