Trial Outcomes & Findings for A Study to Evaluate Long-Term Safety of Multiple Doses of Tapentadol (CG5503) Prolonged-Release (PR) and Oxycodone Controlled-Release (CR) in Patients With Chronic Pain (NCT NCT00361504)
NCT ID: NCT00361504
Last Updated: 2014-04-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1123 participants
Primary outcome timeframe
52 weeks
Results posted on
2014-04-29
Participant Flow
The recruitment period for this out-patient, multicenter study occurred between 14 November 2006 \& 25 July 2008.
In this study 1123 participants passed screening, 1121 participants were randomized (2 participants were not randomized in error) \& 1117 participants received at least 1 dose of study medication (4 participants did not receive study medication)
Participant milestones
| Measure |
Tapentadol (CG5503)
Tapentadol (CG5503) extended release (ER) 100 to 250 mg twice daily (BID) for up to one year
|
Oxycodone
Oxycodone controlled release (CR) 20 to 50 mg twice daily (BID) for up to one year.
|
|---|---|---|
|
Overall Study
STARTED
|
894
|
223
|
|
Overall Study
COMPLETED
|
413
|
78
|
|
Overall Study
NOT COMPLETED
|
481
|
145
|
Reasons for withdrawal
| Measure |
Tapentadol (CG5503)
Tapentadol (CG5503) extended release (ER) 100 to 250 mg twice daily (BID) for up to one year
|
Oxycodone
Oxycodone controlled release (CR) 20 to 50 mg twice daily (BID) for up to one year.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
94
|
31
|
|
Overall Study
Lost to Follow-up
|
40
|
7
|
|
Overall Study
Adverse Event
|
203
|
82
|
|
Overall Study
Lack of Efficacy
|
72
|
7
|
|
Overall Study
Resolution of Pain
|
2
|
0
|
|
Overall Study
Study medication non compliant
|
42
|
15
|
|
Overall Study
All other
|
28
|
3
|
Baseline Characteristics
A Study to Evaluate Long-Term Safety of Multiple Doses of Tapentadol (CG5503) Prolonged-Release (PR) and Oxycodone Controlled-Release (CR) in Patients With Chronic Pain
Baseline characteristics by cohort
| Measure |
Tapentadol (CG5503)
n=894 Participants
Tapentadol (CG5503) extended release (ER) 100 to 250mg twice daily (BID) for up to one year
|
Oxycodone
n=223 Participants
Oxycodone controlled release (CR) 20 to 50mg twice daily (BID) for up to one year.
|
Total
n=1117 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
649 Participants
n=5 Participants
|
156 Participants
n=7 Participants
|
805 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
245 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
312 Participants
n=5 Participants
|
|
Age, Continuous
|
56.8 years
STANDARD_DEVIATION 12.51 • n=5 Participants
|
58.1 years
STANDARD_DEVIATION 11.83 • n=7 Participants
|
57.0 years
STANDARD_DEVIATION 12.38 • n=5 Participants
|
|
Sex: Female, Male
Female
|
515 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
640 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
379 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
477 Participants
n=5 Participants
|
|
Region of Enrollment
North America
|
684 participants
n=5 Participants
|
170 participants
n=7 Participants
|
854 participants
n=5 Participants
|
|
Region of Enrollment
Europe
|
210 participants
n=5 Participants
|
53 participants
n=7 Participants
|
263 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: Safety analysis set (All randomized participants who took at least one dose of study medication).
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.
Outcome measures
| Measure |
Tapentadol (CG5503)
n=894 Participants
Tapentadol (CG5503) extended release (ER) 100 to 250mg twice daily (BID) for up to one year
|
Oxycodone
n=223 Participants
Oxycodone controlled release (CR) 20 to 50mg twice daily (BID) for up to one year.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAE)
|
766 Participants
2.986
|
202 Participants
2.470
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: intent-to-treat
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.
Outcome measures
| Measure |
Tapentadol (CG5503)
n=821 Participants
Tapentadol (CG5503) extended release (ER) 100 to 250mg twice daily (BID) for up to one year
|
Oxycodone
n=178 Participants
Oxycodone controlled release (CR) 20 to 50mg twice daily (BID) for up to one year.
|
|---|---|---|
|
Change From Baseline in Average Pain Intensity Scores at Week 52 Using the Numerical Rating Scale (NRS)
|
-3.22 Scores on a Scale
Standard Deviation 2.664
|
-3.14 Scores on a Scale
Standard Deviation 2.409
|
Adverse Events
Tapentadol (CG5503)
Serious events: 49 serious events
Other events: 766 other events
Deaths: 0 deaths
Oxycodone
Serious events: 9 serious events
Other events: 202 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tapentadol (CG5503)
n=894 participants at risk
Tapentadol (CG5503) extended release (ER) 100 to 250mg twice daily (BID) for up to one year
|
Oxycodone
n=223 participants at risk
Oxycodone controlled release (CR) 20 to 50mg twice daily (BID) for up to one year.
|
|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
0.34%
3/894
|
0.00%
0/223
|
|
Cardiac disorders
Acute myocardial infarction
|
0.11%
1/894
|
0.00%
0/223
|
|
Cardiac disorders
Angina Pectoris
|
0.11%
1/894
|
0.00%
0/223
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.11%
1/894
|
0.00%
0/223
|
|
Cardiac disorders
Coronary Artery Disease
|
0.11%
1/894
|
0.00%
0/223
|
|
Cardiac disorders
Myocardial Infarction
|
0.11%
1/894
|
0.00%
0/223
|
|
Cardiac disorders
Ventricular Fibrillation
|
0.11%
1/894
|
0.00%
0/223
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.22%
2/894
|
0.00%
0/223
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.22%
2/894
|
0.00%
0/223
|
|
Gastrointestinal disorders
Colonic Polyp
|
0.11%
1/894
|
0.00%
0/223
|
|
Gastrointestinal disorders
Constipation
|
0.11%
1/894
|
0.00%
0/223
|
|
Gastrointestinal disorders
Diabetic Gastroparesis
|
0.11%
1/894
|
0.00%
0/223
|
|
Gastrointestinal disorders
Dysphagia
|
0.11%
1/894
|
0.00%
0/223
|
|
Gastrointestinal disorders
Gastritis
|
0.11%
1/894
|
0.00%
0/223
|
|
Gastrointestinal disorders
Impaired Gastric Emptying
|
0.11%
1/894
|
0.00%
0/223
|
|
Gastrointestinal disorders
Nausea
|
0.11%
1/894
|
0.00%
0/223
|
|
Gastrointestinal disorders
Volvulus
|
0.11%
1/894
|
0.00%
0/223
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/894
|
0.45%
1/223
|
|
Gastrointestinal disorders
Ileitis
|
0.00%
0/894
|
0.45%
1/223
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/894
|
0.45%
1/223
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.11%
1/894
|
0.00%
0/223
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.11%
1/894
|
0.00%
0/223
|
|
Injury, poisoning and procedural complications
Fibula Fracture
|
0.11%
1/894
|
0.00%
0/223
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
0.11%
1/894
|
0.00%
0/223
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.11%
1/894
|
0.00%
0/223
|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.11%
1/894
|
0.00%
0/223
|
|
Injury, poisoning and procedural complications
Overdose
|
0.11%
1/894
|
0.00%
0/223
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
0.11%
1/894
|
0.00%
0/223
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
0.11%
1/894
|
0.00%
0/223
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.00%
0/894
|
0.45%
1/223
|
|
Infections and infestations
Appendicitis
|
0.11%
1/894
|
0.45%
1/223
|
|
Infections and infestations
Cellulitis
|
0.11%
1/894
|
0.00%
0/223
|
|
Infections and infestations
Diverticulitis
|
0.11%
1/894
|
0.00%
0/223
|
|
Infections and infestations
Gastroenteritis
|
0.11%
1/894
|
0.00%
0/223
|
|
Infections and infestations
Pneumonia
|
0.11%
1/894
|
0.45%
1/223
|
|
Infections and infestations
Pyelonephritis
|
0.11%
1/894
|
0.00%
0/223
|
|
Infections and infestations
Septic Shock
|
0.11%
1/894
|
0.00%
0/223
|
|
Infections and infestations
Urinary Tract Infection
|
0.11%
1/894
|
0.00%
0/223
|
|
General disorders
Asthenia
|
0.11%
1/894
|
0.00%
0/223
|
|
General disorders
Chest Pain
|
0.11%
1/894
|
0.00%
0/223
|
|
General disorders
Drug Withdrawal Syndrome
|
0.11%
1/894
|
0.00%
0/223
|
|
General disorders
Hernia Obstructive
|
0.11%
1/894
|
0.00%
0/223
|
|
General disorders
Oedema Peripheral
|
0.11%
1/894
|
0.00%
0/223
|
|
General disorders
Treatment Failure
|
0.11%
1/894
|
0.00%
0/223
|
|
Nervous system disorders
Syncope
|
0.22%
2/894
|
0.00%
0/223
|
|
Nervous system disorders
Dizziness
|
0.11%
1/894
|
0.00%
0/223
|
|
Nervous system disorders
Nerve Compression
|
0.11%
1/894
|
0.00%
0/223
|
|
Nervous system disorders
Somnolence
|
0.11%
1/894
|
0.00%
0/223
|
|
Psychiatric disorders
Bipolar Disorder
|
0.11%
1/894
|
0.00%
0/223
|
|
Psychiatric disorders
Depression
|
0.11%
1/894
|
0.00%
0/223
|
|
Psychiatric disorders
Euphoric Mood
|
0.11%
1/894
|
0.00%
0/223
|
|
Psychiatric disorders
Substance Abuse
|
0.11%
1/894
|
0.00%
0/223
|
|
Psychiatric disorders
Suicidal Ideation
|
0.11%
1/894
|
0.00%
0/223
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.22%
2/894
|
0.00%
0/223
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.11%
1/894
|
0.90%
2/223
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.11%
1/894
|
0.00%
0/223
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
0.11%
1/894
|
0.00%
0/223
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.11%
1/894
|
0.00%
0/223
|
|
Musculoskeletal and connective tissue disorders
Lumbar Spinal Stenosis
|
0.00%
0/894
|
0.45%
1/223
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.22%
2/894
|
0.00%
0/223
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
0.11%
1/894
|
0.00%
0/223
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.11%
1/894
|
0.00%
0/223
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.11%
1/894
|
0.00%
0/223
|
|
Metabolism and nutrition disorders
Dehydration
|
0.22%
2/894
|
0.00%
0/223
|
|
Metabolism and nutrition disorders
Anorexia
|
0.11%
1/894
|
0.00%
0/223
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.11%
1/894
|
0.00%
0/223
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/894
|
0.45%
1/223
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.11%
1/894
|
0.00%
0/223
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thymoma
|
0.11%
1/894
|
0.00%
0/223
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyoid Neoplasm
|
0.11%
1/894
|
0.00%
0/223
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Gastrointestinal Neoplasm
|
0.00%
0/894
|
0.45%
1/223
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.11%
1/894
|
0.00%
0/223
|
|
Ear and labyrinth disorders
Vertigo
|
0.11%
1/894
|
0.00%
0/223
|
|
Eye disorders
Visual Disturbance
|
0.11%
1/894
|
0.00%
0/223
|
|
Hepatobiliary disorders
Cholecystitis
|
0.11%
1/894
|
0.00%
0/223
|
|
Reproductive system and breast disorders
Breast Mass
|
0.11%
1/894
|
0.00%
0/223
|
|
Reproductive system and breast disorders
Menstrual Disorder
|
0.00%
0/894
|
0.45%
1/223
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.11%
1/894
|
0.00%
0/223
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.11%
1/894
|
0.00%
0/223
|
Other adverse events
| Measure |
Tapentadol (CG5503)
n=894 participants at risk
Tapentadol (CG5503) extended release (ER) 100 to 250mg twice daily (BID) for up to one year
|
Oxycodone
n=223 participants at risk
Oxycodone controlled release (CR) 20 to 50mg twice daily (BID) for up to one year.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
22.6%
202/894
|
38.6%
86/223
|
|
Gastrointestinal disorders
Nausea
|
18.1%
162/894
|
33.2%
74/223
|
|
Gastrointestinal disorders
Dry Mouth
|
9.1%
81/894
|
4.5%
10/223
|
|
Gastrointestinal disorders
Diarrhoea
|
7.9%
71/894
|
5.4%
12/223
|
|
Gastrointestinal disorders
Vomiting
|
7.0%
63/894
|
13.5%
30/223
|
|
Nervous system disorders
Somnolence
|
14.9%
133/894
|
11.2%
25/223
|
|
Nervous system disorders
Dizziness
|
14.8%
132/894
|
19.3%
43/223
|
|
Nervous system disorders
Headache
|
13.3%
119/894
|
7.6%
17/223
|
|
Infections and infestations
Nasopharyngitis
|
5.5%
49/894
|
2.7%
6/223
|
|
Infections and infestations
Sinusitis
|
3.7%
33/894
|
5.8%
13/223
|
|
Psychiatric disorders
Insomnia
|
6.7%
60/894
|
4.0%
9/223
|
|
General disorders
Fatigue
|
9.7%
87/894
|
10.3%
23/223
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.4%
48/894
|
10.3%
23/223
|
Additional Information
Senior Director, Clinical Leader
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Phone: 609-730-4537
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60