Subjects with inadequately controlled, moderate to severe, chronic, cancer-related pain MedDRA version: 9.1 Level: LLT Classification code 10058019 Term: Cancer pain
Conditions
Interventions
Product Code: JNJ-42160443
Pharmaceutical Form: Solution for injection
Current Sponsor code: JNJ-42160443
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration num
Sponsors
Janssen Cilag International NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Have a life expectancy of at least 3 months • Have a diagnosis of moderate to severe pain directly related to an active cancer and inadequately controlled by standard pain therapies; the primary site of pain should not be pain due to treatment of the cancer (eg, post-operative or procedural pain, chemotherapy- or radiotherapy-induced pain, or pain due to other comorbidities related to the cancer (eg, chronic postherpetic neuralgia, chemotherapy-induced neuropathy, osteoporotic fractures) • Currently receiving opioid analgesics at screening: – The baseline, around-the-clock dose should be =60 mg of oral morphine equivalents, not including breakthrough pain medication doses – The baseline opioid dose should be given as a sustained-release formulation at a stable dose for at least 1 week before screening – A stable, baseline opioid dose is defined as a dose that does not fluctuate by more than 50% from the average dose over the 1 week before screening; the dose may fluctuate by more than 50% for up to 2 days, if medically necessary – The baseline opioid dose is expected to remain stable during the double-blind treatment phase – Not more than an average of 4 breakthrough pain medication doses per day during the 1 week before screening • If currently receiving nonopioid analgesics and adjuvant pain therapies (eg, anticonvulsants, antidepressants, NSAIDs, corticosteroids, pharmaceutical cannabinoids [eg, Marinol®, Sativex®, Cesamet™]), must be at stable doses for 2 weeks before screening and expected to remain stable during the double-blind treatment phase • Have an average daily pain intensity score of =4 averaged over the last 3 days before randomization (Day 1), where the minimum single assessment score is =2, and a worst pain score of =5 averaged over the last 3 days before randomization, using an 11-point NRS, with 0=no pain and 10=pain as bad as you can imagine. Subjects must have recorded NRS pain assessments in their e-diary for at least 2 of the 3 days before randomization to determine eligibility for entry into the double-blind treatment phase. 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
Exclusion criteria: • Presence of neurologic deficits that are: – Grade 3 or higher motor or sensory deficits, graded according to the Modified Neuropathy Common Terminology Criteria for Adverse Events, or – Unstable or progressive, or – Stable for 20 mm Hg or decrease in diastolic blood pressure of >10 mm Hg within 3 minutes of standing up, or – a decrease in systolic blood pressure of at least 40 mm Hg within 3 minutes of standing up, or – a decrease in diastolic blood pressure of at least 20 mm Hg within 3 minutes of standing up • History of bone marrow transplant (BMT) within the past 10 years. If a subject had BMT >10 years ago, must not have had a history of graft versus host disease and not currently receiving immunosuppressive therapy. • History of leukemia • History of small cell lung cancer • History of neuroendocrine tumors • History of any of the following: – Seizure disorders within the past year – Multiple sclerosis within the past year – Intrathecal therapy, Ommaya reservoirs, and ventricular shunts within the past year – Radiotherapy to the cerebral or spinal areas within 3 months before the screening visit – Mild or moderate traumatic brain injury within the past year – Stroke within the past year – Transient ischemic attack within the past year – Severe traumatic brain injury within the past 15 years (consisting of = 1 of the following: brain contusion, intracranial hematoma, either unconsciousness or posttraumatic amnesia lasting more than 24 hours) or with residual sequelae suggesting transient changes in consciousness – Any other condition suggesting compromised blood brain barrier (contact the sponsor’s medical officer to discuss if unclear) • Presence of known or suspected cerebral metastases • Any other condition suggesting compromised blood brain barrier (contact the sponsor’s medical officer to discuss if unclear) • Presence of disseminated or severe organ-related herpes virus disease (eg, cytomegalovirus retinitis or cytomegalovirus nephritis) • Presence of severe chronic obstructive pulmonary disease (COPD) • Oxygen saturation (SpO2) 2 L/min of oxygen therapy will also be excluded irrespective of their oxygen saturation value at screening. • Alanine aminotransaminase (ALT) or aspartate aminotransaminase (AST) =3 times the upper limit of normal (ULN) • Serum creatinine of =2 mg/dL • Planned initiation of new chemotherapy regimen or radiotherapy, bisphosphonates, or hormonal or growth factor therapy during the double-blind treatment phase • Planned major surgical procedure during the double-blind treatment phase • Currently using patient-controlled analgesia or IV opioids as chronic baseline pain therapy • Currently receiving =60 mg-equivalents of prednisone per day To be eligible to enter the open-label extension phase, the following key criterion mu
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the analgesic efficacy, safety, and tolerability of a single SC dose (9 mg in 0.9 mL) of JNJ-42160443 compared with placebo as adjunctive therapy to standard pain therapy in subjects with inadequately controlled, moderate to severe, chronic, cancer-related pain. The primary efficacy objective of this study is to evaluate the analgesic effect of JNJ-42160443 compared with placebo, as measured by the change from baseline to the end of the double-blind treatment phase in the average cancer-related pain intensity score, using an 11-point numerical rating scale (NRS), with 0=no pain and 10=pain as bad as you can imagine. ;Secondary Objective: The secondary objectives of this study are to evaluate the efficacy of JNJ-42160443 compared with placebo, as measured by the Brief Pain Inventory (BPI) Short Form, Patient and Clinical Global Impression of Change (PGIC and CGIC), and baseline and breakthrough opioid use and to evaluate the immunogenicity (antibodies to JNJ-42160443) associated with JNJ-42160443 treatment. The pharmacokinetics of JNJ-42160443 after SC doses will also be examined. Exploratory Objectives The exploratory objectives of this study are to investigate the effects of improvements in pain relief with JNJ-42160443 on the severity of fatigue, aspects of daily activities, and anxiety/depression. ;Primary end point(s): The primary efficacy evaluation is the average cancer-related pain intensity in the last 24 hours using an 11-point NRS, with 0=no pain and 10=pain as bad as you can imagine. The primary efficacy endpoint is the change from baseline to the end of the double-blind treatment phase in the average cancer-related pain intensity score, averaged over the last 3 days before randomization and over the last 7 days of the double-blind treatment phase. The average cancer-related pain intensity score is based on the average pain in the last 24 hours item recorded daily in the e-diary. | — |
Countries
France, Italy, Netherlands, Portugal, Spain
Outcome results
None listed