Phase 4
Completed N=66
A Study to Assess the Efficacy and Safety of Oxycodone/Naloxone in Korean Patients With Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Source: ClinicalTrials.gov NCT01675531 ↗Enrolled (actual)
66
Serious AEs
2.8%
Results posted
Dec 2016
Primary outcomePrimary: NRS (Numeric Rating Scale) — -1.29 units on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
A multicenter, phase IV, interventional study to assess the efficacy and safety of Targin (Oxycodone/Naloxone) Korean patients with CIPN (Chemotherapy-Induced Peripheral Neuropathy) who need opioid combination treatment with existing pregabalin of last dose prior to study enrollment without changing.
The investigators will assess study objectives as below.
Primary objective
* To assess the pain reduction rate after 4 weeks treatment from baseline (week 0)
Secondary objectives
* To assess the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACIT-GOG/NTX)
* To assess physician's overall satisfaction
* To assess subject's overall satisfaction
* To assess safety
The investigators have a hypothesis that Targin will show favorable efficacy & safety profile for CIPN patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY NRS (Numeric Rating Scale) |
-1.29 | — |
| SECONDARY Mean Change in FACT-GOG/NTX From Visit1(Week 0) to Visit 4(Week 4 Post-treatment). |
-2.78 | — |
| SECONDARY Physician's Overall Satisfaction |
0; 3; 2; 25; 19; 16 | — |
| SECONDARY Patient's Overall Satisfaction |
0; 3; 2; 26; 15; 18 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female ≥ 20 and 2.5 times the upper limit of normal, it is allowed >5 times the upper limit of normal in case of transition in liver) or an abnormal total bilirubin and/or creatinine level(s) (greater than 1.5 times the upper limit of normal), gamma glutamyl transpeptidase (GGT or GGTP) ≥ 3 times the upper limit of normal
- Patients with uncontrolled seizures
- Requiring interventional treatment for pain such as neural blockade procedure or regional infusion
- Patients with increased intracranial pressure
- In the investigator's opinion, subjects who are receiving hypnotics or other central nervous system (CNS) depressants that may pose a risk of additional CNS depression with opioid study medication
- Patients with myxoedema, not adequately treated hypothyroidism or Addison's disease
- Patients receiving opioid substitution therapy for opioid addiction (e.g. methadone or buprenorphine)
- Clinically significant impairment of cardiovascular, respiratory and renal function
- Major surgery within 1 month prior to screening or planned surgery
- Chemotherapy or radiotherapy within 2 weeks prior to the screening visit, or planned chemotherapy or radiotherapy during the study period.
- Mainly pain originated other than Chemotherapy-Induced Peripheral Neuropathy
- Patients with diabetic neuropathy
- With a disability that may prevent the patient from completing all study requirements and in particular, interfere with 24hrs pain intensity score
- Patients known to have, or suspected of having a history of drug abuse
- Patients with history of opioid or drug dependence
- Any situation where opioids are contraindicated
- Having used other investigational drugs at the time of enrollment, or within 30 days of enrollment
Data sourced from ClinicalTrials.gov (NCT01675531). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.