| Symproic (naldemedine) / Shionogi, Collegium Pharma |
ChiCTR2200061564: A study of efficacy and safety of Naldemedine in cancer patients with opioid-induced constipation (OIC) |
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| Not yet recruiting | 4 | 12 | | Naldemedine tablet | Hainan General Hospital; Hainan General Hospital, Supported by Ping An-Shionogi Co., Ltd. | Opioid-induced constipation | | | | |
ChiCTR2400089290: A multicenter study of naldemedine in cancer patients with opioid-induced constipation consisting of a placebo-controlled study period followed by an open study period |
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| Completed | 3 | 120 | | In Period 1: Naldemedine at a dose of 0.2 mg (naldemedine 0.2 mg tablet × 1) will be orally administered once daily for 14 days. In Period 2: Naldemedine at a dose of 0.2 mg (naldemedine 0.2 mg tablet × 1) will be orally administered once daily for up to 10 weeks. ; In period 1: Placebo tablet matching the naldemedine 0.2 mg tablet will be orally administered once daily for 14 days. In period 2: Naldemedine at a dose of 0.2 mg (naldemedine 0.2 mg tablet × 1) will be orally administered once daily for up to 10 weeks. | The Second Hospital of Anhui Medical University; Ping An-Shionogi Co., Ltd., Supported by Ping An-Shionogi Co., Ltd. | Opioid-induced constipation | | | | |
2021-000069-34: The effects of peripheral opioid receptor antagonism on recurrent acute pancreatitis Effekten af perifer opioid antagonisme på recidiverende akut pankreatitis |
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| Ongoing | 2/3 | 120 | Europe | Naldemedine 0.2mg Film-coated Tablet, Film-coated tablet | Mech-Sense, Aalborg University Hospital, The Novo Nordisk Foundation, Shionogi B.V. | Recurrent acute pancreatitis, Recurrent acute inflammation of the pancreas, Diseases [C] - Digestive System Diseases [C06] | | | | |
| Active, not recruiting | 2/3 | 74 | Europe | Placebo treatment, Naldemedine 0.2 MG Oral Tablet | Asbjørn Mohr Drewes, Odense University Hospital, Hvidovre University Hospital, University Hospital Bispebjerg and Frederiksberg, Karolinska University Hospital | Pancreatitis, Acute | 03/24 | 06/24 | | |
NCT06334198: The Effect of Naldemedine on Opioid-induced Bowel Dysfunction |
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| Recruiting | 2 | 20 | Europe | Naldemedine, Placebo, Tramadol | Asbjørn Mohr Drewes | Opioid-Induced Bowel Dysfunction, Constipation | 03/25 | 03/25 | | |
| Recruiting | 1/2 | 24 | Europe | Naldemedine, Rizmoic | Shionogi, Shionogi & Co. Ltd | Opioid-Induced Constipation (OIC) | 06/26 | 06/26 | | |
ChiCTR2300076608: A phase 1, open-label, single-dose, multiple-dose study to evaluate the safety, tolerability, and pharmacokinetic characteristics of naldemedine in healthy Chinese adult subjects |
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| Completed | 1 | 10 | | Naldemedine Tablet | The Second Hospital of Anhui Medical University; Ping An-Shionogi Co., Ltd., Supported by Ping An-Shionogi Co., Ltd. | Opioid-induced constipation | | | | |
jRCTs031200397: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial of the Preventive Effect of Naldemedine on Opioid-Induced Constipation |
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| Completed | N/A | 100 | Japan | Symproic (naldemedine) - Shionogi, Collegium Pharma | University of Tsukuba Hospital, Japanese Society for Palliative Medicine | Neoplasms | | | | |
NCT03720613: Risk of Major Adverse Cardiovascular Events for Naldemedine and Other Medications for Opioid Induced Constipation in Adults With Chronic Non-Cancer Pain |
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| Recruiting | N/A | 34532 | US | Naldemedine, Symproic®, Lubiprostone, Amitiza®, Naloxegol, Movantik® | BioDelivery Sciences International, HealthCore, Inc. | Opioid-induced Constipation | 11/30 | 11/30 | | |
