Randomized, Double-Blind, Active-Control, Parallel Group, 90-Day Safety Study of CG5503 Immediate Release or Oxycodone Immediate Release in Subjects With Chronic Pain from Low Back Pain or Osteoarthritis of the Hip or Knee - n.a

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2006-003278-93-GB
• Date of registration: 23/11/2006
• Prospective Registration: Yes
• Primary sponsor: Johnson & Johnson Pharamceutical Research & Development, L.L.C.
• Public title: Randomized, Double-Blind, Active-Control, Parallel Group, 90-Day Safety Study of CG5503 Immediate Release or Oxycodone Immediate Release in Subjects With Chronic Pain from Low Back Pain or Osteoarthritis of the Hip or Knee - n.a
• Scientific title: Randomized, Double-Blind, Active-Control, Parallel Group, 90-Day Safety Study of CG5503 Immediate Release or Oxycodone Immediate Release in Subjects With Chronic Pain from Low Back Pain or Osteoarthritis of the Hip or Knee - n.a
• Date of first enrolment: 31/01/2007
• Target sample size: 875
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-003278-93
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
Subjects must satisfy the following criteria to be enrolled in the study:
• Men or women =18 years of age, inclusive
• Must be ambulatory, not planning surgery for the duration of the study and able to complete all study related procedures and requirements throughout the trial period
• Women must be postmenopausal, surgically sterile, or practicing or agree to practice an effective method of birth control if they are sexually active before entry and throughout the study (effective methods of birth control include prescription hormonal contraceptives, intrauterine devices, double barrier method, and male partner sterilization). Women of childbearing potential must have a negative serum ß-human chorionic gonadotropin (ß-hCG) pregnancy test at screening and a negative urine pregnancy test on Day 1
• Subjects must use satisfactory contraception from the first dose of study drug up to 7 days after the last dose of study drug
• A clinical diagnosis of one of the following:
- Low back pain of non-malignant origin for at least 3 months
- Osteoarthritis of the knee or hip for at least 3 months
• Require daily doses of analgesia medication for chronic pain that is consistent with or makes them candidates for treatment at Step 2 or higher of the World Health Organization (WHO) Pain Relief Ladder. The regular daily analgesia may consist of NSAIDs or opioids taken for at least the 30 days before screening, alone or in combination, to control chronic pain. Opioid use must be no more than 80 mg morphine equivalents per day
• Post-washout baseline PI score =4 on an 11-point numerical rating scale
• The subject has willingly signed an informed consent document indicating that he or she understands the purpose of and procedures required in the study, and before undergoing any study procedure
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
• Women who plan to become pregnant during the study, or who are breastfeeding
• Received an experimental drug or used an experimental medical device within 30 days before screening or has participated in a previous study of CG5503
• History of malignancy within the past 2 years, with the exception of basal cell carcinoma
• Contraindications to, history of allergy to, or hypersensitivity to CG5503, oxycodone, hydromorphone, morphine, or fentanyl, or their excipients
• Systemic steroid therapy, excluding inhalers or topical steroids, within 3 months before screening
• Injectable hyaluronic acid within 6 months before screening
• Currently treated with monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs) or neuroleptics. Selective serotonin reuptake inhibitor (SSRI) and serotonin norepinephrine reuptake inhibitor (SNRIs) treatments are allowed if taken for at least 30 days before the screening period of the study at an unchanged dose
• History of chronic hepatitis B or C, or HIV 1 and 2, or presence of active hepatitis B or C within the past 3 months before screening
• Uncontrolled hypertension (systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 95 mmHg)
• Uncontrolled or poorly controlled post-traumatic stress disorder (PTSD), generalized anxiety disorder (GAD), depression, psychiatric or other significant medical condition(s)
• History of seizure disorder or epilepsy suggested by the presence of any of the following:
- Mild or moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm within 1 year of screening
- Severe traumatic brain injury, episode(s) of unconsciousness or post-traumatic amnesia of more than 24 hours duration within 15 years of screening
• History of alcohol and/or drug abuse
• Concomitant autoimmune inflammatory condition
• Acute crystal-induced arthropathy within the 6 months before screening
• Laboratory values reflecting moderate to severe renal insufficiency or hepatic impairment based on alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values greater than 3 times the upper limit of normal (ULN)
• Pending litigation due to a history of chronic pain or disability
• Clinically significant disease that in the investigator’s opinion may affect efficacy or safety assessment
• Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

moderate to severe pain
MedDRA version: 8.1 Level: LLT Classification code 10033371 Term: Pain

Intervention(s)

Product Name: CG5503; R331333
Product Code: CG5503; R331333
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Tapentadol
CAS Number: 175591-09-0
Current Sponsor code: CG5503; R331333
Other descriptive name: (-)-(1R,2R)-3-(3-Dimethylamino-1-ethyl- 2-methyl-propyl)-phenol hydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Trade Name: OxyNorm® 5, 10, 20 mg
Product Name: OxyNorm®
Product Code: n.a.
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Oxycodone
Current Sponsor code: n.a.
Other descriptive name: n.a.
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-

Trade Name: OxyNorm® 5, 10, 20 mg
Product Name: OxyNorm®
Product Code: n.a.
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Oxycodone
Current Sponsor code: n.a.
Other descriptive name: n.a.
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)

Main Objective: The primary objective of the study is to evaluate the safety profile of CG5503 base IR 50 mg or 100 mg taken every 4 to 6 hours as needed over the long term exposure of 90 days

Secondary Objective: The secondary objectives include:
• Estimate the relative safety profile of CG5503 and oxycodone subjects
• Evaluation of the symptoms of withdrawal from opioids following discontinuation of study drug using the Clinical Opioid Withdrawal Score (COWS) and the Subjective Opioid Withdrawal Score (SOWS) questionnaires.
• Evaluation of symptoms related to GI tolerability (i.e., constipation and vomiting) using the Patient Assessment of Constipation Symptoms (PAC SYM), a single question regarding vomiting, and a sleep assessment
• Assessment of pain intensity (PI) over the 90-day study period
• Assessment of the Patient Global Impression of Change (PGIC) as recorded at the end of treatment

Primary end point(s): Safety:
• Collection of adverse events
• Changes in clinical laboratory, ECG vital signs and findings on physical examinations
• Patient assessment of constipation using the PAC-SYM, assessment of vomiting and assessment of sleep
• Symptoms of opioid withdrawal using COWS and SOWS scales
Efficacy:
• Changes in Pain Intensity Scale versus baseline
• Patient’s Global Assessment of Change versus baseline

Secondary ID(s)

n.a.

KF5503/34-R331333-PAI-3004