Pain with neuropathic features in cancer subjects which is inadequately controlled despite optimized opioid treatment MedDRA version: 14.0 Level: LLT Classification code 10045158 Term: Tumor pain System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Katadolon 100mg, Hartkapsel
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: FLUPIRTINE MALEATE
CAS Number: 75507-68-5
Concentration unit: mg milligram(s)
Concentration type: equal
Sponsors
Relevare Pharmaceuticals, Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Presence of a solid neoplasm and between the ages of 18 and 65 years, inclusive 2. Able to understand written and verbal communication in the primary language of the country in which the study is being undertaken 3. Life expectancy a minimum of 3 months with Karnofsky score =50 at the Screening Visit (Day -7) 4. History of daily pain attributable to cancer and requiring treatment with strong opioids for at least 3 months duration 5. Pain with neuropathic characteristics that include one or more of the following: throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, splitting, tiring-exhausting, sickening, fearful, punishing-cruel, electric-shock, cold-freezing, piercing, caused by light touch, itching, tingling or ‘pins and needles’, or numbness. 6. Pain inadequately relieved despite active management including strong opioids 7. Currently taking morphine, oxycodone, hydromorphone, buprenorphine, or transdermal fentanyl for daily, non-breakthrough pain management (i.e., maintenance opioid treatment) with no changes in dose in the 2 weeks preceding the Screening Visit (Day -7) 8. Completion of a daily diary in which the 24-hour AP score has been entered for at least 5 of the last 7 days preceding Day 1 9. Average of non-missing 24-hour AP scores over the last 7 days before the day of randomization is 4 or greater 10. If on gabapentin, pregabalin or selective serotonin reuptake inhibitors (SSRIs) or tricyclic antidepressants, no changes in dose in the 2 weeks preceding the Screening Visit (Day -7) 11. Willing to maintain existing analgesic medications, including maintenance opioid treatment, at same dose(s) and schedule for a minimum of 6 weeks following the Screening Visit (Day -7) 12. Able to take oral medication 13. If female subject of childbearing potential, a negative serum beta human chorionic gonadotropin (hCG) pregnancy test, performed at the Screening Visit (Day -7). Must be willing to use effective methods of birth control and/or refrain from participating in a conception process during the study and for 30 days following study drug exposure. 14. Willing and able to comply with protocol requirements for the duration of study participation 15. Contractual capability and signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 280 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1. Medical condition or illness other than solid neoplasm that would, in the opinion of the Investigator, preclude study participation or interfere with the assessment of pain 2. Abnormal liver or kidney function as defined by alanine aminotransferase (ALT), aspartate aminotransferase (AST) or alkaline phosphatase in excess of 3 times the upper limit of normal, or chronic kidney disease worse than stage II (glomerular filtration rate 2x ULN)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to explore the overall analgesic efficacy of flupirtine administered in combination with opioids for a period of 5 weeks.;Secondary Objective: Secondary objectives of this study are to: - Investigate the safety and tolerability of flupirtine administered in combination with opioids; - Investigate the efficacy of flupirtine using various secondary measures of efficacy. ;Primary end point(s): Change in the 11-point Likert scale for average daily pain from the baseline mean pain score (the mean of non-missing daily diary entries for average pain during the 7 days before randomization) to the final mean pain score (the mean of last 7 daily diary entries for average pain during the Treatment Period);Timepoint(s) of evaluation of this end point: Day 36 visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Percentage of subjects achieving at least 30% improvement from baseline based on the primary efficacy endpoint; - Physician and Subject Global Assessment of study drug; - Change in the 11-point Likert scale from the baseline mean pain score to the mean pain score during each week of the Treatment Period; - Percentage of subjects achieving pre-specified pain reduction thresholds (e.g., 20% to 100%); and - Opioid consumption, BPI (short-form), average pain the past 24 hours, least pain in past 24 hours, and worst pain in past 24 hours. ;Timepoint(s) of evaluation of this end point: Day 36 visit | — |
Countries
Germany
Contacts
Public ContactVice President Clinical Operations
Relevare Pharmaceuticals, Ltd.
Outcome results
None listed