(429) Randomized, double-blind, placebo-controlled, phase 3 study of the safety and analgesic efficacy of MNK-155 extended-release hydrocodone bitartrate/acetaminophen tablets (HB/APAP ER) in an acute pain model

N. Singla; R. Margulis; K. Kostenbader; Y. Zheng; T. Barrett; M. Giuliani; J. Young

doi:10.1016/j.jpain.2014.01.340

(429) Randomized, double-blind, placebo-controlled, phase 3 study of the safety and analgesic efficacy of MNK-155 extended-release hydrocodone bitartrate/acetaminophen tablets (HB/APAP ER) in an acute pain model

Journal of Pain ◽

10.1016/j.jpain.2014.01.340 ◽

2014 ◽

Vol 15 (4) ◽

pp. S83

Author(s):

N. Singla ◽

R. Margulis ◽

K. Kostenbader ◽

Y. Zheng ◽

T. Barrett ◽

...

Keyword(s):

Acute Pain ◽

Extended Release ◽

Analgesic Efficacy ◽

Phase 3 ◽

Double Blind ◽

Pain Model ◽

Double Blind Placebo ◽

Hydrocodone Bitartrate

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Poster 528 Open-Label Extension of a Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Safety and Analgesic Efficacy of MNK-795 Oxycodone/Acetaminophen Extended-Release Tablets in an Acute Pain Model

PM&R ◽

10.1016/j.pmrj.2014.08.896 ◽

2014 ◽

Vol 6 (9) ◽

pp. S371-S372

Author(s):

Neil Singla ◽

Thomas Barrett ◽

Lisa Sisk ◽

Kenneth Kostenbader ◽

Jim Young

Keyword(s):

Acute Pain ◽

Extended Release ◽

Analgesic Efficacy ◽

Open Label ◽

Phase 3 ◽

Double Blind ◽

Pain Model ◽

Double Blind Placebo ◽

Open Label Extension

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1.71 A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY (P302) ASSESSING THE EFFICACY AND SAFETY OF SPN-812 (EXTENDED-RELEASE VILOXAZINE) 200 AND 400MG FOR THE TREATMENT OF ADHD IN ADOLESCENTS

Journal of the American Academy of Child & Adolescent Psychiatry ◽

10.1016/j.jaac.2019.08.476 ◽

2019 ◽

Vol 58 (10) ◽

pp. S170

Author(s):

Azmi Nasser ◽

Gregory D. Busse ◽

Joseph Hull ◽

Fatima Chowdhry ◽

Toyin Adewole ◽

...

Keyword(s):

Extended Release ◽

Controlled Study ◽

Efficacy And Safety ◽

Phase 3 ◽

Double Blind ◽

Double Blind Placebo

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EPA-0666 – Long-term maintenance of efficacy of extended-release guanfacine hydrochloride (GXR) in children and adolescents with attention-deficit/hyperactivity disorder (ADHD): double-blind, placebo-controlled, multicentre, phase 3 randomized withdrawal study

European Psychiatry ◽

10.1016/s0924-9338(14)78034-4 ◽

2014 ◽

Vol 29 ◽

pp. 1 ◽

Cited By ~ 3

Author(s):

J. Newcorn ◽

V. Harpin ◽

M. Huss ◽

M. Johnson ◽

J.A. Ramos-Quiroga ◽

...

Keyword(s):

Attention Deficit Hyperactivity Disorder ◽

Attention Deficit ◽

Extended Release ◽

Phase 3 ◽

Double Blind ◽

Double Blind Placebo ◽

Multicentre Phase ◽

Hyperactivity Disorder ◽

Term Maintenance

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Analgesic efficacy and tolerability of oxycodone 5 mg/ibuprofen400 mg compared with those of oxycodone 5 mg/acetaminophen 325 mg and hydrocodone 7.5 mg/acetaminophen 500 mg in patients with moderate to severe postoperative pain: A randomized, double-blind, placebo-controlled, single-dose, parallel-group study in a dental pain model

Clinical Therapeutics ◽

10.1016/j.clinthera.2005.04.010 ◽

2005 ◽

Vol 27 (4) ◽

pp. 418-429 ◽

Cited By ~ 46

Author(s):

L LITKOWSKI ◽

S CHRISTENSEN ◽

D ADAMSON ◽

T VANDYKE ◽

S HAN ◽

...

Keyword(s):

Single Dose ◽

Postoperative Pain ◽

Analgesic Efficacy ◽

Dental Pain ◽

Double Blind ◽

Pain Model ◽

Double Blind Placebo ◽

Parallel Group Study ◽

Parallel Group ◽

Severe Postoperative Pain

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1.72 A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY (P303) ASSESSING THE EFFICACY AND SAFETY OF SPN-812 (EXTENDED-RELEASE VILOXAZINE) 200 AND 400 MG FOR THE TREATMENT OF ADHD IN CHILDREN

Journal of the American Academy of Child & Adolescent Psychiatry ◽

10.1016/j.jaac.2019.08.483 ◽

2019 ◽

Vol 58 (10) ◽

pp. S170

Author(s):

Azmi Nasser ◽

Gregory D. Busse ◽

Joseph Hull ◽

Fatima Chowdhry ◽

Toyin Adewole ◽

...

Keyword(s):

Extended Release ◽

Controlled Study ◽

Efficacy And Safety ◽

Phase 3 ◽

Double Blind ◽

Double Blind Placebo

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(416) Open-label 14-Day safety extension of a randomized, double-blind, placebo-controlled trial of biphasic immediate-release/extended-release hydrocodone bitartrate/acetaminophen tablets for acute postoperative pain

Journal of Pain ◽

10.1016/j.jpain.2015.01.335 ◽

2015 ◽

Vol 16 (4) ◽

pp. S80

Author(s):

Y. Zheng ◽

R. Margulis ◽

K. Kostenbader ◽

T. Barrett

Keyword(s):

Postoperative Pain ◽

Extended Release ◽

Controlled Trial ◽

Immediate Release ◽

Acute Postoperative Pain ◽

Open Label ◽

Double Blind ◽

Double Blind Placebo ◽

Hydrocodone Bitartrate

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A randomized, double-blind, placebo-controlled study of the efficacy and safety of MNK-795, a dual-layer, biphasic, immediate-release and extended-release combination analgesic for acute pain

Current Medical Research and Opinion ◽

10.1185/03007995.2013.876979 ◽

2014 ◽

Vol 30 (3) ◽

pp. 349-359 ◽

Cited By ~ 9

Author(s):

Neil Singla ◽

Thomas Barrett ◽

Lisa Sisk ◽

Kenneth Kostenbader ◽

Jim Young ◽

...

Keyword(s):

Acute Pain ◽

Extended Release ◽

Immediate Release ◽

Controlled Study ◽

Efficacy And Safety ◽

Double Blind ◽

Double Blind Placebo

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1.70 A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY (P301) ASSESSING THE EFFICACY AND SAFETY OF SPN-812 (EXTENDED-RELEASE VILOXAZINE) 100 AND 200MG FOR THE TREATMENT OF ADHD IN CHILDREN

Journal of the American Academy of Child & Adolescent Psychiatry ◽

10.1016/j.jaac.2019.08.475 ◽

2019 ◽

Vol 58 (10) ◽

pp. S169-S170

Author(s):

Azmi Nasser ◽

Gregory D. Busse ◽

Joseph Hull ◽

Fatima Chowdhry ◽

Toyin Adewole ◽

...

Keyword(s):

Extended Release ◽

Controlled Study ◽

Efficacy And Safety ◽

Phase 3 ◽

Double Blind ◽

Double Blind Placebo

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Comparison of acetaminophen 1000 mg and acetaminophen 650 mg in an acute pain model: results from a randomized, double-blind, placebo-controlled, efficacy and safety study

Osteoarthritis and Cartilage ◽

10.1016/j.joca.2012.02.267 ◽

2012 ◽

Vol 20 ◽

pp. S175

Author(s):

D.S. Qi ◽

L.G. May ◽

B.A. Zimmerman ◽

P.Y. Peng ◽

E.O. Atillasoy ◽

...

Keyword(s):

Acute Pain ◽

Efficacy And Safety ◽

Safety Study ◽

Double Blind ◽

Pain Model ◽

Double Blind Placebo

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PMS4 EUROQOL-5 DIMENSION HEALTH STATUS QUESTIONNAIRE RESULTS FROM A RANDOMIZED, DOUBLE-BLIND, PLACEBO- AND ACTIVE-CONTROLLED PHASE 3 STUDY OF TAPENTADOL EXTENDED RELEASE (ER) FOR THE MANAGEMENT OF CHRONIC OSTEOARTHRITIS KNEE PAIN

Value in Health ◽

10.1016/s1098-3015(10)75144-5 ◽

2009 ◽

Vol 12 (7) ◽

pp. A433-A434 ◽

Cited By ~ 1

Author(s):

S Kavanagh ◽

J Ashworth ◽

B Lange ◽

MS Etropolski ◽

I Van Hove ◽

...

Keyword(s):

Health Status ◽

Knee Pain ◽

Extended Release ◽

Phase 3 ◽

Double Blind ◽

Double Blind Placebo ◽

Health Status Questionnaire ◽

Osteoarthritis Knee

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