An 12-week, Prospective, Interventional, Single-arm, Multi-centre, Phase III Study to Examine the Efficacy and Safety of Flutiform K-haler in Asthma Patients Who Are Not Adequately Controlled by Mid-doseICS/LABA DPI Treatment

The purpose of this study is to evaluate the efficacy of the Asthma improvement of Flutiform K-haler after 12 weeks of treatment in patients with moderate to severe uncontrolled* asthma following mid-dose ICS/LABA DPI therapy.

Start Date26 Nov 2019

Sponsor / Collaborator

Mundipharma Korea Ltd.

NCT03768466 / CompletedPhase 4

An 8-week, Prospective, Interventional, Single-arm, Multi-centre, Phase IV Study to Evaluate the Efficacy and Safety of Controlled-release Oxycodone/Naloxone (Targin®) in Moderate to Severe Low Back Pain Patients Who Are Not Adequately Controlled by NSAIDs

The purpose of this study is to evaluate the efficacy of the study drug (Targin®) after 8 weeks of treatment in patients with moderate to severe low back pain who are uncontrolled* by NSAIDs.

Start Date21 Nov 2018

Sponsor / Collaborator

Mundipharma Korea Ltd.

NCT02660541 / CompletedNot Applicable

A Pilot Study to Compare Efficacy of Allevyn® Silver Dressing and Betafoam® in Patients With Wound of Acute Burn Injury

This is a randomized, controlled, multi-centre, open-label study.
A total of 40 patients will be enrolled in this study. Patients will be randomly assigned to Betafoam® or Allevyn® Silver dressing for burn wounds after acute burn injury.

Start Date21 Jun 2016

Sponsor / Collaborator

Mundipharma Korea Ltd.

100 Clinical Results associated with Mundipharma Korea Ltd.

0 Patents (Medical) associated with Mundipharma Korea Ltd.

Literatures (Medical) associated with Mundipharma Korea Ltd.

01 Jan 2018·Clinics in Orthopedic Surgery

Analgesic Efficacy and Safety of Prolonged-Release Oxycodone/Naloxone in Korean Patients with Chronic Pain from Spinal Disorders

Article

Author: Kim, Jin-Hyok ; Park, Hye-Jeong ; Ahn, Jae-Sung ; Hwang, Chang Ju ; Kim, Dong-Soo ; Lee, Jae Hyup ; Moon, Seong-Hwan ; Park, Ye-Soo ; Lee, Kyu-Yeol ; Cho, Kyu-Jung ; Chung, Sung Soo

BACKGROUNDA prolonged-release formulation of oxycodone/naloxone has been shown to be effective in European populations for the management of chronic moderate to severe pain. However, no clinical data exist for its use in Korean patients. The objective of this study was to assess efficacy and safety of prolonged-release oxycodone/naloxone in Korean patients for management of chronic moderate-to-severe pain.METHODSIn this multicenter, single-arm, open-label, phase IV study, Korean adults with moderate-to-severe spinal disorder-related pain that was not satisfactorily controlled with weak opioids and nonsteroidal anti-inflammatory drugs received prolonged-release oral oxycodone/naloxone at a starting dose of 10/5 mg/day (maximum 80/40 mg/day) for 8 weeks. Changes in pain intensity and quality of life (QoL) were measured using a numeric rating scale (NRS, 0-10) and the Korean-language EuroQol-five dimensions questionnaire, respectively.RESULTSAmong 209 patients assessed for efficacy, the mean NRS pain score was reduced by 25.9% between baseline and week 8 of treatment (p < 0.0001). There was also a significant improvement in QoL from baseline to week 8 (p < 0.0001). The incidence of adverse drug reactions was 27.7%, the most common being nausea, constipation, and dizziness; 77.9% of these adverse drug reactions had resolved or were resolving at the end of the study.CONCLUSIONSProlonged-release oxycodone/naloxone provided significant and clinically relevant reductions in pain intensity and improved QoL in Korean patients with chronic spinal disorders. (ClinicalTrials.gov identifier: NCT01811238).

01 Dec 2017·Chinese Journal of Cancer

Efficacy and safety of controlled-release oxycodone/naloxone versus controlled-release oxycodone in Korean patients with cancer-related pain: a randomized controlled trial

Article

Author: Kim, Tae Won ; Kim, Jin-Soo ; Ahn, Jin-Seok ; Lee, Gyeong-Won ; Kim, Sun-Young ; Kang, Jung-Hun ; Koh, Sung Ae ; Kim, Jeong Eun ; Eum, Young-Jun ; Lee, Kyung-Hee ; Hong, Yong Sang ; Kim, Min Kyoung ; Yun, Hwan-Jung

AbstractBackgroundControlled-release oxycodone/naloxone (OXN-CR) maintains the effect of opioid-induced analgesia through oxycodone while reducing the occurrence rate of opioid-induced constipation through naloxone. The present study was designed to assess the non-inferiority of OXN-CR to controlled-release oxycodone (OX-CR) for the control of cancer-related pain in Korean patients.MethodsIn this randomized, open-labeled, parallel-group, phase IV study, we enrolled patients aged 20 years or older with moderate to severe cancer-related pain [numeric rating scale (NRS) pain score ≥4] from seven Korean oncology/hematology centers. Patients in the intention-to-treat (ITT) population were randomized (1:1) to OXN-CR or OX-CR groups. OXN-CR was administered starting at 20 mg/10 mg per day and up-titrated to a maximum of 80 mg/40 mg per day for 4 weeks, and OX-CR was administered starting at 20 mg/day and up-titrated to a maximum of 80 mg/day for 4 weeks. The primary efficacy endpoint was the change in NRS pain score from baseline to week 4, with non-inferiority margin of −1.5. Secondary endpoints included analgesic rescue medication intake, patient-reported change in bowel habits, laxative intake, quality of life (QoL), and safety assessments.ResultsOf the ITT population comprising 128 patients, 7 with missing primary efficacy data and 4 who violated the eligibility criteria were excluded from the efficacy analysis. At week 4, the mean change in NRS pain scores was not significantly different between the OXN-CR group (n = 58) and the OX-CR group (n = 59) (−1.586 vs. −1.559, P = 0.948). The lower limit of the one-sided 95% confidence interval (−0.776 to 0.830) for the difference exceeded the non-inferiority margin (P < 0.001). The OXN-CR and OX-CR groups did not differ significantly in terms of analgesic rescue medication intake, change in bowel habits, laxative intake, QoL, and safety assessments.ConclusionsOXN-CR was non-inferior to OX-CR in terms of pain reduction after 4 weeks of treatment and had a similar safety profile. Studies in larger populations of Korean patients with cancer-related pain are needed to further investigate the effectiveness of OXN-CR for long-term pain control and constipation alleviation.Trial registration ClinicalTrials.gov NCT01313780, registered March 8, 2011

01 Jan 2017·Pain Research and ManagementQ3 · MEDICINE

Intravenous Oxycodone versus Intravenous Morphine in Cancer Pain: A Randomized, Open-Label, Parallel-Group, Active-Control Study

Q3 · MEDICINE

ArticleOA

Author: Choi, Moon-Ki ; Park, Hye-Jeong ; Kang, Jung-Hun ; Eum, Young-Jun ; Shim, Byoung-Yong ; Oh, Ho-Suk ; Kang, Jin-Hyong ; Lee, Kyung-Hee

Objective. To compare efficacy and safety of intravenous continuous infusion of oxycodone with morphine in patients with cancer pain.Methods. A 5-day, randomized, open-label, exploratory study at 6 sites in the Republic of Korea. Sixty-six adults aged ≥19 years with moderate-to-severe cancer pain (Numeric Rating Scale [NRS] ≥ 4) were enrolled. The study group received intravenous (IV) oxycodone, and the comparator group received IV morphine which were titrated depending on pain intensity. The efficacy endpoint is change in average NRS score from baseline to Day 5. Other assessments included worst, current, and average pain intensity; patient satisfaction; medication dose; and adverse events.Results. Both groups achieved >50% reduction in average pain intensity: from “moderate” at baseline (oxycodone versus morphine: 6.0 ± 1.8 versus 5.9 ± 1.4) to “mild” at Day 5 (2.5 ± 1.8 versus 2.8 ± 1.6). While this reduction was similar between groups (3.5 ± 2.2 versus 3.1 ± 1.8,Pvalue = 0.562), oxycodone achieved faster pain relief (average pain: 3.0 ± 1.6 versus 3.9 ± 1.6,Pvalue = 0.020) on Day 2 and significant NRS reductions for worst pain on Day 2 (Pvalue = 0.045) and current pain on Day 2 (Pvalue = 0.035) and Day 5 (Pvalue = 0.020) compared to morphine. Patient satisfaction, adverse events, and adverse drug reactions were similar for both groups.Conclusions. For Asian patients with cancer pain, IV oxycodone is faster acting and showed similar analgesic efficacy and safety profiles as IV morphine. This trial is registered with Clinicaltrials.govNCT02660229.

100 Deals associated with Mundipharma Korea Ltd.

100 Translational Medicine associated with Mundipharma Korea Ltd.

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