Home > Protocol Summaries: Compounds > paroxetine Protocol Summaries: paroxetine GSKStudy ID Phase Title Status 104228 phase 4 Post-marketing clinical study on PAXIL Tablet in patients with depression or depressive mood - A study on combination of PAXIL Tablet and benzodiazepines Completed 112301 phase 4 Drug Use Investigation for PAXIL Tablet Completed 112302 phase 4 Special Drug Use Investigation for PAXIL Tablet (Long-term) Completed 112304 phase 4 Special Drug Use Investigation for PAXIL Tablet (20mg-Clinical Symptom Progression) Completed 112308 phase 4 Special Drug Use Investigation for PAXIL Tablet (Investigation in case of administered from 20mg/day) Completed 112309 phase 4 Special Drug Use Investigation for PAXIL Tablet (Pediatric Panic Disorder) Completed 112487 phase 4 A randomised, double-blind, placebo controlled, parallel group , flexible dose study to evaluate the efficacy and safety of Paxil® Tablets in children and adolescents with Major Depressive Disorder<Post-marketing clinical study> Completed 112810 phase 3 A Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Clinical Effects of Controlled Release Paroxetine in the Treatment of Major Depressive Disorder Completed 112811 phase 1 An open label, randomized, three-period crossover study to compare the pharmacokinetic profile of paroxetine after single doses of the controlled-release paroxetine tablets at the dose levels of 12.5, 25 and 50mg in healthy Japanese male subjects Completed 112812 phase 1 A steady-state, two-period crossover study to compare the pharmacokinetic profile of paroxetine after repeated daily dosing of the controlled-release paroxetine tablet (25 mg) with that of the standard immediate-release paroxetine tablet (20 mg) in healthy Japanese male subjects Completed 113939 phase 1 Relative bioavailability study between the formulations: Paroxetine 25 mg tablet with controlled release manufactured by GSK Mississauga and Paroxetine 25 mg tablets with controlled release manufactured by SmithKline Beecham (Cidra), fasted administration in healthy volunteers for both genders. Completed 114035 phase 1 Relative bioavailability study between the formulations: Paroxetine 25 mg tablets with controlled release manufactured by GSK Mississauga and Paroxetine 25 mg tablets with controlled release manufactured by SmithKline Beecham (Cidra), fed administration in healthy volunteers of both genders Completed 114102 Special Drug Use Investigation for PAXIL (paroxetine) Social Anxiety Disorder (Long-term) Active not recruiting 115734 IMI PROTECT (Work Package 2): Use of antidepressants and risk of hip and/or hip/femur fracture Active not recruiting 116554 n\a Incident Type II Diabetes Mellitus Among Patients Exposed to the Combination of Pravastatin and Paroxetine Active not recruiting 29060/799 phase 3 Clinical Evaluation of BRL29060A (Paroxetine Hydrochloride Hydrate) in Posttraumatic Stress Disorder (PTSD) - A 52-Week, Non-Comparative, Uncontrolled Study for the Clinical Use Experience - <Open-Label Study> Completed 29060/874 phase 3 A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Fixed Dose Study Evaluating the Efficacy and Safety of Paroxetine CR in Elderly Outpatients Diagnosed with Major Depressive Disorder Completed BRL29060A/856 phase 2 Clinical Evaluation of BRL29060 A in Generalized Anxiety Disorder Completed NKP102280 phase 2 See Detailed Description Completed PCR103124 phase 3 A Multicentre, Double-blind, Active Controlled Trial to Evaluate the Clinical Effects of Immediate Release Paroxetine and Controlled Release Paroxetine in the Treatment of Major Depression Completed PCR104074 Phase 1 A randomized, open, three-period crossover study to compare the pharmacokinetic profile of paroxetine after single dosing of each enteric-coated Geomatrix control release tablet strength (12.5, 25, 37.5mg) in healthy Chinese subjects Completed PCR104075 Phase 1 A steady-state study to assess the pharmacokinetic profile of paroxetine after 14 day repeated daily dosing of the controlled release paroxetine tablet (25 mg) in healthy Chinese subjects Completed PCR111656 phase 1 An open-label, randomized, single dose, two-period crossover study to demonstrate bioequivalence between the controlled release paroxetine tablet (37.5 mg) manufactured at Cidra and Mississauga Completed PIR104776 phase 3 Clinical Evaluation of BRL29060A (Paroxetine Hydrochloride Hydrate) in Social Phobia/Social Anxiety Disorder (SAD) -A Double-blind, Placebo-controlled Study- <Phase III Study> Completed PIR104777 phase 3 Clinical Evaluation of BRL29060A (Paroxetine Hydrochloride Hydrate) in Social Phobia/Social Anxiety Disorder (SAD) -A Open-Label, Uncontrolled, Long-term Study- <Phase III Study> Completed PIR109164 phase 2 Clinical Evaluation of BRL29060A (Paroxetine Hydrochloride Hydrate) in Posttraumatic Stress Disorder (PTSD) - A Placebo-controlled, Single-Blind Comparative Study - Terminated SB29060.833 Phase 4 An open label study assessing Paxil CR (paroxetine CR) in patients with major depressive disorder who discontinued treatment with selective serotonin reuptake inhibitors or a selective serotonin/norepinephrine reuptake inhibitor due to intolerability Completed TMT106386 Phase 1 A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, fMRI and PET Study Comparing Emotional Challenge-induced Regional Cerebral Blood Flow Changes Before and After 8 Weeks of Treatment With Placebo and Paroxetine in Subjects with Social Anxiety Disorder Completed
