A Study to Evaluate Long-Term Safety of Multiple Doses of... | NCT00361504

ID	Type	Description	Link
R331333PAI3007	Other Identifier	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Name	Class
Grünenthal GmbH	INDUSTRY

Description Module

Detailed Description

Tapentadol (CG5503) is a centrally active pain-relieving drug being investigated for the treatment of acute and chronic pain. This study is a randomized (patients are assigned different treatments based on chance in a ratio of 4 patients on tapentadol (CG5503) PR to every 1 patient on oxycodone CR), open-label (both the Investigator and the patient know what medication is allocated), active-controlled, parallel-group, multicenter study. It is designed to investigate the long-term safety (side effects during up to one year of administration) and effectiveness (level of pain control) of tapentadol (CG5503) PR compared to oxycodone CR (an opioid commonly used for relief of moderate to severe pain) taken orally. The study consisted of a screening period (up to 14 days), a washout period (3 to 7 days), and an active treatment phase with titration and maintenance (total duration of 52 weeks). The doses of both of these medications will be adjusted to give the best therapeutic benefit for the patient. A total of 1123 patients will be screened. Safety evaluations include monitoring of adverse events, physical examinations, and clinical laboratory tests. Assessments of pain relief include the pain intensity numerical rating scale, and patient global impression of change scale (PGIC). Venous blood samples will be collected for the determination of serum concentrations of tapentadol (CG5503) and oxycodone. Tapentadol (CG5503) PR is also referred to as Tapentadol (CG5503) Extended Release (ER). Starting oral dose is randomly assigned to tapentadol (CG5503) PR 50 mg or oxycodone CR 10 mg twice daily (BID) x 3 days; then increase to tapentadol (CG5503)100 mg BID, oxycodone CR 20 mg BID x 4 days; during the maintenance phase upward titration may occur at a minimum of 3 day intervals in increments of tapentadol (CG5503) PR 50 mg BID or oxycodone CR 10 mg BID. The maximum doses are tapentadol (CG5503) PR 250 mg BID or oxycodone CR 50 mg BID.

Label	Type	Description	Intervention Names
Tapentadol (CG5503)	Experimental	Tapentadol (CG5503) extended release (ER) 100 to 250 mg twice daily (BID) for up to one year.	Drug: Tapentadol (CG5503) ER
Oxycodone	Active Comparator	Oxycodone controlled release (CR) 20 to 50 mg twice daily (BID) for up to one year.	Drug: Oxycodone CR

Name	Type	Description	Arm Group Labels	Other Names
Oxycodone CR	Drug	Oxycodone CR 10 mg oral tablet BID administered for first 3 days, 20 mg oral tablet BID administered for next 4 days, 20 to 50 mg oral tablet BID administered for the next 51 weeks.

Measure	Description	Time Frame
Number of Participants With Treatment-emergent Adverse Events (TEAE)	The number of participants who reported a TEAE during the treatment period. TEAE was defined as any adverse event that started or worsened on or after the start of the study medication and up to 3 days after the discontinuation of the study medication.	52 weeks

Measure	Description	Time Frame
Change From Baseline in Average Pain Intensity Scores at Week 52 Using the Numerical Rating Scale (NRS)	The Participants indicated the average level of pain experienced, at each study visit, over the previous 24 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". Baseline was the average pain intensity scores measured prior to randomization (At Week 1). At Week 52 again the average pain intensity scores were collected and the change in scores at Week 52 from the baseline scores was considered as the change from baseline in average pain intensity scores at Week 52.

Name	Affiliation	Role
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Study Director

PubMed Identifier	Type	Citation	Retractions
24985410	Derived	Etropolski M, Kuperwasser B, Flugel M, Haufel T, Lange B, Rauschkolb C, Laschewski F. Safety and tolerability of tapentadol extended release in moderate to severe chronic osteoarthritis or low back pain management: pooled analysis of randomized controlled trials. Adv Ther. 2014 Jun;31(6):604-20. doi: 10.1007/s12325-014-0128-6. Epub 2014 Jul 2.
23340531

ID	Title	Description
FG000	Tapentadol (CG5503)	Tapentadol (CG5503) extended release (ER) 100 to 250 mg twice daily (BID) for up to one year
FG001	Oxycodone	Oxycodone controlled release (CR) 20 to 50 mg twice daily (BID) for up to one year.

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Treatment-emergent Adverse Events (TEAE)

The number of participants who reported a TEAE during the treatment period. TEAE was defined as any adverse event that started or worsened on or after the start of the study medication and up to 3 days after the discontinuation of the study medication.

Safety analysis set (All randomized participants who took at least one dose of study medication).

Posted

Number

Participants

52 weeks

ID	Title	Description
OG000	Tapentadol (CG5503)	Tapentadol (CG5503) extended release (ER) 100 to 250mg twice daily (BID) for up to one year
OG001	Oxycodone	Oxycodone controlled release (CR) 20 to 50mg twice daily (BID) for up to one year.

Units	Counts
Participants	OG000894 OG001223

Title

Denominators

Categories

Title	Measurements
	OG000766± 2.986 OG001202± 2.470

Secondary

Change From Baseline in Average Pain Intensity Scores at Week 52 Using the Numerical Rating Scale (NRS)

The Participants indicated the average level of pain experienced, at each study visit, over the previous 24 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". Baseline was the average pain intensity scores measured prior to randomization (At Week 1). At Week 52 again the average pain intensity scores were collected and the change in scores at Week 52 from the baseline scores was considered as the change from baseline in average pain intensity scores at Week 52.

intent-to-treat

Posted

Mean

Standard Deviation

Scores on a Scale

Baseline, Week 52

ID	Title	Description
OG000	Tapentadol (CG5503)	Tapentadol (CG5503) extended release (ER) 100 to 250mg twice daily (BID) for up to one year
OG001	Oxycodone	Oxycodone controlled release (CR) 20 to 50mg twice daily (BID) for up to one year.

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Atrial Fibrillation	Cardiac disorders	Non-systematic Assessment	EG0003 affected894 at risk EG0010 affected223 at risk
Acute myocardial infarction	Cardiac disorders	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Angina Pectoris	Cardiac disorders	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Cardiac Failure Congestive	Cardiac disorders	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Coronary Artery Disease	Cardiac disorders	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Myocardial Infarction	Cardiac disorders	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Ventricular Fibrillation	Cardiac disorders	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Abdominal Pain	Gastrointestinal disorders	Non-systematic Assessment	EG0002 affected894 at risk EG0010 affected223 at risk
Intestinal Obstruction	Gastrointestinal disorders	Non-systematic Assessment	EG0002 affected894 at risk EG0010 affected223 at risk
Colonic Polyp	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Constipation	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Diabetic Gastroparesis	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Dysphagia	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Gastritis	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Impaired Gastric Emptying	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Nausea	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Volvulus	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Colitis	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected894 at risk EG0011 affected223 at risk
Ileitis	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected894 at risk EG0011 affected223 at risk
Small Intestinal Obstruction	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected894 at risk EG0011 affected223 at risk
Ankle Fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Femoral Neck Fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Fibula Fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Foot Fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Hip Fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Lower Limb Fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Overdose	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Subdural Haematoma	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Thermal Burn	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Ligament Sprain	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 affected894 at risk EG0011 affected223 at risk
Appendicitis	Infections and infestations	Non-systematic Assessment	EG0001 affected894 at risk EG0011 affected223 at risk
Cellulitis	Infections and infestations	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Diverticulitis	Infections and infestations	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Gastroenteritis	Infections and infestations	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Pneumonia	Infections and infestations	Non-systematic Assessment	EG0001 affected894 at risk EG0011 affected223 at risk
Pyelonephritis	Infections and infestations	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Septic Shock	Infections and infestations	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Urinary Tract Infection	Infections and infestations	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Asthenia	General disorders	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Chest Pain	General disorders	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Drug Withdrawal Syndrome	General disorders	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Hernia Obstructive	General disorders	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Oedema Peripheral	General disorders	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Treatment Failure	General disorders	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Syncope	Nervous system disorders	Non-systematic Assessment	EG0002 affected894 at risk EG0010 affected223 at risk
Dizziness	Nervous system disorders	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Nerve Compression	Nervous system disorders	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Somnolence	Nervous system disorders	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Bipolar Disorder	Psychiatric disorders	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Depression	Psychiatric disorders	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Euphoric Mood	Psychiatric disorders	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Substance Abuse	Psychiatric disorders	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Suicidal Ideation	Psychiatric disorders	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0002 affected894 at risk EG0010 affected223 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 affected894 at risk EG0012 affected223 at risk
Arthritis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Joint Swelling	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Pain in Extremity	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Lumbar Spinal Stenosis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 affected894 at risk EG0011 affected223 at risk
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0002 affected894 at risk EG0010 affected223 at risk
Acute Respiratory Distress Syndrome	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Dehydration	Metabolism and nutrition disorders	Non-systematic Assessment	EG0002 affected894 at risk EG0010 affected223 at risk
Anorexia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Hypoglycemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Hypokalemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 affected894 at risk EG0011 affected223 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Thymoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Thyoid Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Benign Gastrointestinal Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0000 affected894 at risk EG0011 affected223 at risk
Hydrocele	Congenital, familial and genetic disorders	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Vertigo	Ear and labyrinth disorders	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Visual Disturbance	Eye disorders	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Cholecystitis	Hepatobiliary disorders	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Breast Mass	Reproductive system and breast disorders	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Menstrual Disorder	Reproductive system and breast disorders	Non-systematic Assessment	EG0000 affected894 at risk EG0011 affected223 at risk
Erythema	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk
Deep Vein Thrombosis	Vascular disorders	Non-systematic Assessment	EG0001 affected894 at risk EG0010 affected223 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Mesa	Arizona		United States

ID	Term
D015207	Osteoarthritis, Hip
D020370	Osteoarthritis, Knee
D017116	Low Back Pain
D010146	Pain
D010003	Osteoarthritis
D001416	Back Pain

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals

ID	Title	Description
BG000	Tapentadol (CG5503)	Tapentadol (CG5503) extended release (ER) 100 to 250mg twice daily (BID) for up to one year
BG001	Oxycodone	Oxycodone controlled release (CR) 20 to 50mg twice daily (BID) for up to one year.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Tapentadol (CG5503)	Tapentadol (CG5503) extended release (ER) 100 to 250mg twice daily (BID) for up to one year			49	894	766	894
EG001	Oxycodone	Oxycodone controlled release (CR) 20 to 50mg twice daily (BID) for up to one year.			9	223	202	223