Comparing the effectiveness of magnesium oxide and naldemedine in preventing opioid-induced constipation: a proof of concept, single institutional, two arm, open-label, phase II, randomized controlled trial: the MAGNET study
Abstract Background Patients taking opioids are known to develop opioid-induced constipation (OIC), which reduces their quality of life. The aim of this study is to compare magnesium oxide with naldemedine and determine which is more effective in preventing OIC. Methods This proof-of-concept, prospe...
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| Format: | Article |
| Language: | English |
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BMC
2020-06-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-020-04385-0 |
| _version_ | 1828758490310508544 |
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| author | Anna Ozaki Takaomi Kessoku Michihiro Iwaki Takashi Kobayashi Tsutomu Yoshihara Takayuki Kato Yasushi Honda Yuji Ogawa Kento Imajo Takuma Higurashi Masato Yoneda Masataka Taguri Takeharu Yamanaka Hiroto Ishiki Noritoshi Kobayashi Satoru Saito Yasushi Ichikawa Atsushi Nakajima |
| author_facet | Anna Ozaki Takaomi Kessoku Michihiro Iwaki Takashi Kobayashi Tsutomu Yoshihara Takayuki Kato Yasushi Honda Yuji Ogawa Kento Imajo Takuma Higurashi Masato Yoneda Masataka Taguri Takeharu Yamanaka Hiroto Ishiki Noritoshi Kobayashi Satoru Saito Yasushi Ichikawa Atsushi Nakajima |
| author_sort | Anna Ozaki |
| collection | DOAJ |
| description | Abstract Background Patients taking opioids are known to develop opioid-induced constipation (OIC), which reduces their quality of life. The aim of this study is to compare magnesium oxide with naldemedine and determine which is more effective in preventing OIC. Methods This proof-of-concept, prospective, randomized controlled trial commenced in Japan in March 2018. Initially, a questionnaire-based survey will be conducted targeting adult patients with cancer who concomitantly commenced opioid treatment and OIC prevention treatment. Patients will then be randomly allocated to a magnesium oxide group (500 mg thrice daily) or a naldemedine group (0.2 mg once daily). Each drug will be orally administered for 12 weeks. The primary endpoint is defined as any improvement in scores on the Japanese version of Patient Assessment of Constipation Quality of Life questionnaire (JPAC-QOL) from baseline to 2 weeks of treatment. Discussion The primary endpoint is change in JPAC-QOL score from baseline to 2 weeks of intervention. The key secondary endpoint will be change in spontaneous bowel movements at 2 and 12 weeks of intervention. This study will determine whether magnesium oxide or naldemedine is more effective for the prevention of OIC. Trial registration University Hospital Medical Information Network (UMIN) Clinical Trials Registry, UMIN000031891 . Registered March 25, 2018. |
| first_indexed | 2024-12-11T00:42:47Z |
| format | Article |
| id | doaj.art-185396bd185f4cbc83702cd124f1c8cb |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-11T00:42:47Z |
| publishDate | 2020-06-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-185396bd185f4cbc83702cd124f1c8cb2022-12-22T01:26:51ZengBMCTrials1745-62152020-06-012111910.1186/s13063-020-04385-0Comparing the effectiveness of magnesium oxide and naldemedine in preventing opioid-induced constipation: a proof of concept, single institutional, two arm, open-label, phase II, randomized controlled trial: the MAGNET studyAnna Ozaki0Takaomi Kessoku1Michihiro Iwaki2Takashi Kobayashi3Tsutomu Yoshihara4Takayuki Kato5Yasushi Honda6Yuji Ogawa7Kento Imajo8Takuma Higurashi9Masato Yoneda10Masataka Taguri11Takeharu Yamanaka12Hiroto Ishiki13Noritoshi Kobayashi14Satoru Saito15Yasushi Ichikawa16Atsushi Nakajima17Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of MedicineDepartment of Gastroenterology and Hepatology, Yokohama City University Graduate School of MedicineDepartment of Gastroenterology and Hepatology, Yokohama City University Graduate School of MedicineDepartment of Gastroenterology and Hepatology, Yokohama City University Graduate School of MedicineDepartment of Gastroenterology and Hepatology, Yokohama City University Graduate School of MedicineDepartment of Gastroenterology, International University of Health and Welfare Atami HospitalDepartment of Gastroenterology and Hepatology, Yokohama City University Graduate School of MedicineDepartment of Gastroenterology and Hepatology, Yokohama City University Graduate School of MedicineDepartment of Gastroenterology and Hepatology, Yokohama City University Graduate School of MedicineDepartment of Gastroenterology and Hepatology, Yokohama City University Graduate School of MedicineDepartment of Gastroenterology and Hepatology, Yokohama City University Graduate School of MedicineDepartment of Biostatistics, Yokohama City University Graduate School of MedicineDepartment of Biostatistics, Yokohama City University Graduate School of MedicineDepartment of Palliative Medicine, National Cancer Center HospitalDepartment of Oncology, Yokohama City University HospitalDepartment of Gastroenterology and Hepatology, Yokohama City University Graduate School of MedicineDepartment of Palliative Care Center, Yokohama City University HospitalDepartment of Gastroenterology and Hepatology, Yokohama City University Graduate School of MedicineAbstract Background Patients taking opioids are known to develop opioid-induced constipation (OIC), which reduces their quality of life. The aim of this study is to compare magnesium oxide with naldemedine and determine which is more effective in preventing OIC. Methods This proof-of-concept, prospective, randomized controlled trial commenced in Japan in March 2018. Initially, a questionnaire-based survey will be conducted targeting adult patients with cancer who concomitantly commenced opioid treatment and OIC prevention treatment. Patients will then be randomly allocated to a magnesium oxide group (500 mg thrice daily) or a naldemedine group (0.2 mg once daily). Each drug will be orally administered for 12 weeks. The primary endpoint is defined as any improvement in scores on the Japanese version of Patient Assessment of Constipation Quality of Life questionnaire (JPAC-QOL) from baseline to 2 weeks of treatment. Discussion The primary endpoint is change in JPAC-QOL score from baseline to 2 weeks of intervention. The key secondary endpoint will be change in spontaneous bowel movements at 2 and 12 weeks of intervention. This study will determine whether magnesium oxide or naldemedine is more effective for the prevention of OIC. Trial registration University Hospital Medical Information Network (UMIN) Clinical Trials Registry, UMIN000031891 . Registered March 25, 2018.http://link.springer.com/article/10.1186/s13063-020-04385-0Opioid-induced constipationMagnesium oxideNaldemedineRandomized controlled trial |
| spellingShingle | Anna Ozaki Takaomi Kessoku Michihiro Iwaki Takashi Kobayashi Tsutomu Yoshihara Takayuki Kato Yasushi Honda Yuji Ogawa Kento Imajo Takuma Higurashi Masato Yoneda Masataka Taguri Takeharu Yamanaka Hiroto Ishiki Noritoshi Kobayashi Satoru Saito Yasushi Ichikawa Atsushi Nakajima Comparing the effectiveness of magnesium oxide and naldemedine in preventing opioid-induced constipation: a proof of concept, single institutional, two arm, open-label, phase II, randomized controlled trial: the MAGNET study Trials Opioid-induced constipation Magnesium oxide Naldemedine Randomized controlled trial |
| title | Comparing the effectiveness of magnesium oxide and naldemedine in preventing opioid-induced constipation: a proof of concept, single institutional, two arm, open-label, phase II, randomized controlled trial: the MAGNET study |
| title_full | Comparing the effectiveness of magnesium oxide and naldemedine in preventing opioid-induced constipation: a proof of concept, single institutional, two arm, open-label, phase II, randomized controlled trial: the MAGNET study |
| title_fullStr | Comparing the effectiveness of magnesium oxide and naldemedine in preventing opioid-induced constipation: a proof of concept, single institutional, two arm, open-label, phase II, randomized controlled trial: the MAGNET study |
| title_full_unstemmed | Comparing the effectiveness of magnesium oxide and naldemedine in preventing opioid-induced constipation: a proof of concept, single institutional, two arm, open-label, phase II, randomized controlled trial: the MAGNET study |
| title_short | Comparing the effectiveness of magnesium oxide and naldemedine in preventing opioid-induced constipation: a proof of concept, single institutional, two arm, open-label, phase II, randomized controlled trial: the MAGNET study |
| title_sort | comparing the effectiveness of magnesium oxide and naldemedine in preventing opioid induced constipation a proof of concept single institutional two arm open label phase ii randomized controlled trial the magnet study |
| topic | Opioid-induced constipation Magnesium oxide Naldemedine Randomized controlled trial |
| url | http://link.springer.com/article/10.1186/s13063-020-04385-0 |
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