Patients are stratified based on their initial pain score in the recovery room. patients with a pain numeric rating scale of greater than or equal to 7/10 are stratified to the "high" group. then randomized to receive gabapentin 200 mg tid x 9 doses, or placebo x 9 doses. Patients with a pain score equal to or less than 6/10 are stratified to the "low" group, then randomized to receive gabapentin 200mg tid x 9 doses or placebo x 9 doses.
All patients receive Acetaminophen 1gm every 6 hours for 3 days, Celecoxib 400mg as a loading dose then 200mg twice a day for 3 days. Patients also receive patient controlled analgesia (PCA) of hydromorphone for 24 hrs, then are transitioned to oxycodone 5-15 mg every 2 hours as needed.

Prostate Cancer

Gabapentin

Placebo Sugar Pill

Sunnybrook Health Sciences Center

Does Postoperative Gabapentin Reduce Pain, Opioid Consumption and Anxiety and Have a Positive Effect on Health Related Quality of Life After Radical Prostatectomy?

Does Postoperative Gabapentin Reduce Pain, Opioid Consumption & Anxiety & Have a Positive Effect on Health Related Quality of Life After Radical Prostatectomy?

Jason Sawyer

Sunnybrook Health Sciences Centre

Arthritis, Rheumatoid

TAK-715 25 mg, tablets, orally, twice daily and methotrexate stable dose for up to 6 weeks.

TAK-715 and methotrexate

TAK-715 50 mg, tablets, orally, twice daily and methotrexate stable dose for up to 6 weeks.

TAK-715 100 mg, tablets, orally, twice daily and methotrexate stable dose for up to 6 weeks.

TAK-715 placebo-matching, tablets, orally, twice daily and methotrexate stable dose for up to 6 weeks

Methotrexate

Safety and Efficacy of TAK-715 in Subjects With Rheumatoid Arthritis

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of Oral TAK-715 in the Treatment of the Signs and Symptoms of Rheumatoid Arthritis

Sr. VP, Clinical Science

Takeda

Androgen Deprivation Therapy [ADT] (plus Radiotherapy for newly-diagnosed non-metastatic disease, plus or minus Docetaxel, plus or minus Abiraterone)[Control]

(ADT + zoledronic acid) NO LONGER RECRUITING

(ADT + docetaxel + prednisolone) NO LONGER RECRUITING

(ADT + zoledronic acid + docetaxel + prednisolone) NO LONGER RECRUITING

(ADT + zoledronic acid + celecoxib) NO LONGER RECRUITING

(ADT + abiraterone acetate + prednisolone) NO LONGER RECRUITING

(ADT + radiotherapy to the prostate) NO LONGER RECRUITING

(ADT + abiraterone + enzalutamide + Prednisolone) NO LONGER RECRUITING

(ADT + Metformin) RECRUITING IN SELECTED SITES

Celecoxib

Docetaxel

Prednisolone

Zoledronic Acid

Abiraterone

Radiotherapy to the prostate

Enzalutamide

Metformin

Transdermal Oestradiol

Kantonsspital Graubuenden

Lausanne Centre Hospitalier Universitaire

Winterthur Hospital

Hirslanden Klinik Aarau

Universitaetsspital-Basel

Inselspital Bern

Liestal Hospital

Kantonsspital - St. Gallen

UniversitaetsSpital Zuerich

City Hospital Triemli

Berkshire Cancer Centre at Royal Berkshire Hospital

Royal Bolton Hospital

Wycombe General Hospital

Addenbrooke's Hospital

Broomfield Hospital

Countess of Chester Hospital

James Cook University Hospital

Cumberland Infirmary

North Devon District Hospital

Royal Devon and Exeter Hospital

Royal Bournemouth Hospital

Dorset County Hospital

Poole Hospital

Castle Hill Hospital

Eastbourne District General Hospital

Conquest Hospital

William Harvey Hospital

Stoke Mandeville Hospital

Basingstoke and North Hampshire NHS Foundation Trust

City Hospital (Birmingham)

Sussex Cancer Centre at Royal Sussex County Hospital

Burnley General Hospital

Queen's Hospital

West Suffolk Hospital

Mid Cheshire Hospitals Trust- Leighton Hopsital

Darlington Memorial

Derbyshire Royal Infirmary

Doncaster Royal Infirmary

Russells Hall Hospital

University Hospital of North Durham

Gloucestershire Royal Hospital

Hereford County Hospital

Kidderminster Hospital

Leeds Cancer Centre at St. James's University Hospital

Glenfield Hospital

Royal Liverpool University Hospital

University Hospital Aintree

Helen Rollason Cancer Care Centre at North Middlesex Hospital

Guy's Hospital

St. Mary's Hospital

UCL Cancer Institute

University College of London Hospitals

Withington Hospital

Royal Shrewsbury Hospital

Stepping Hill Hospital

Sunderland Royal Hospital

Torbay Hospital

Warrington Hospital NHS Trust

West Cumberland Hospital

Royal Albert Edward Infirmary

Worcester Royal Hospital

Worthing Hospital

Princess Alexandra Hospital

Southend University Hospital NHS Foundation Trust

South West Wales Cancer Institute At Singleton Hospital

Cheltenham General Hospital

St. Bartholomews Hospital

Queen Elizabeth Hospital - Woolwich

St. George's Hospital

Charing Cross Hospital

Christie Hospital

Royal Oldham Hospital

Southampton General Hospital

Lister Hospital

Raigmore Hospital

Airedale General Hospital

Kent and Canterbury Hospital

Mid Kent Oncology Centre at Maidstone Hospital

Queen Elizabeth The Queen Mother Hospital

Beatson Institute for Cancer Research - Glasgow

Rosemere Cancer Centre at Royal Preston Hospital

Southport and Formby District General Hospital

Mount Vernon Cancer Centre at Mount Vernon Hospital

Edinburgh Cancer Centre at Western General Hospital

Freeman Hospital

Scarborough General Hospital

Centre for Cancer Research and Cell Biology at Queen's University Belfast

Nottingham City Hospital

King's Mill Hospital

Churchill Hospital

Queen Alexandra Hospital

Ayr Hospital

Royal United Hospital

Bristol Haematology and Oncology Centre

Musgrove Park Hospital

Weston General Hospital

Yeovil District Hospital

Cancer Research Centre at Weston Park Hospital

Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy

STAMPEDE: Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy: A Multi-Stage Multi-Arm Randomised Controlled Trial

Report of time from initiation of treatment to the first progression event of each patient

Reporting the comparison of costs associated with the additional treatments provided and the survival gain attributed to the additional treatments, to SOC alone.

Determination of changes in quality of life with interventions

Reporting the incidence, type and severity of side effects within the trial populaiton. CTCAE v4.0 will be used to classify the events names and severity.

Reporting the incidence and types of skeletal related events

For the purposes of the STAMPEDE trial, a unique threshold PSA value for biochemical failure is calculated for each patient, referred to as the PSA progression value.
A. If PSA nadir in the 24 weeks following randomisation is more than 4ng/ml and more than 50% of the pre-treatment PSA level - immediate treatment failure.
B. If PSA nadir in the 24 weeks following randomisation is less than or equal to 50% of the pre-treatment PSA level but remains above 4ng/ml - treatment failure will be defined as a rise of 50% above the nadir level.
C. If PSA nadir in the 24 weeks following randomisation is less than or equal to 4ng/ml - treatment failure will be defined as at least 50% rise above the nadir value and also above 4ng/ml.

Reporting the incidence of mortality without a progression event

Reporting the incidence and severity of lymph node events

Reporting the incidence and severity of distant metastatic events

Identifying and reporting the treatments used in second line treatment. Incidence and types of treatments.

Reporting the mortality attributed to Prostate Cancer

Reporting the mortality not attributed to Prostate Cancer

Reporting the incidence and severity of effects on metabolic systems

Medical Research Council

cyclooxygenase

fatigue

cyclooxygenase/fatigue

Does Postoperative Gabapentin Reduce Pain, Opioid Consumption and Anxiety and Have a Positive Effect on Health Related Quality of Life After Radical Prostatectomy?

Safety and Efficacy of TAK-715 in Subjects With Rheumatoid Arthritis

Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy

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