6 completed, 3 recruiting, 2 unknown, 1 terminated. 6 Phase 2, 4 Phase 3, 1 Phase 1, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 6 | Completed 2, Unknown 2, Recruiting 1, Terminated 1 |
| Phase 3 | 4 | Completed 3, Unknown 1 |
| Phase 1 | 1 | Recruiting 1 |
| Phase 4 | 1 | Completed 1 |
Follow this drug Literature Review of naldemedine trials Research Report on naldemedine
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Naldemedine in Clinical Practice in Cancer Patients With Opioid Induced CONstipation: Clinical Outcomes and Patient Experience Naldemedine, an peripherally acting opioid antagonist - Cancer, Opioid Induced Constipation (OIC) | Recruiting | Professor Monique A. H. Steegers | 100 | 2026-01-02 | 2026-01-02 | |
| Prophylactic Use of Naldemedine on Opioid-induced Nausea and Vomiting in Patients With Cancer: POSEIDON Study Naldemedine, Placebo - Opioid-Induced Nausea and Vomitting(OINV) | Phase 4 | Completed | International University of Health and Welfare | 120 | 2025-06-20 | 2026-06-03 |
| The Effect of Naldemedine on Opioid-induced Bowel Dysfunction Naldemedine, Placebo, Tramadol - Opioid-Induced Bowel Dysfunction, Constipation | Phase 2 | Unknown | Asbjørn Mohr Drewes | 20 | 2024-03-12 | 2024-03-28 |
| Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids Naldemedine - Opioid-Induced Constipation (OIC) | Phase 1 / Phase 2 | Recruiting | Shionogi | 24 | 2023-01-04 | 2026-07-28 |
| Effects of a Peripherally Acting µ-opioid Receptor Antagonist on Recurrent Acute Pancreatitis Placebo treatment, Naldemedine 0.2 MG Oral Tablet - Pancreatitis, Acute | Phase 2 / Phase 3 | Unknown | Asbjørn Mohr Drewes | 74 | 2022-01-12 | 2024-03-21 |
| A Study of Naldemedine in Participants Undergoing Surgeries That Include a Bowel Resection or Bowel Transection Naldemedine, Placebo - Postoperative Gastrointestinal Dysfunction | Phase 2 | Terminated | Shionogi | 2 | 2020-11-06 | 2022-01-18 |
| Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation Naldemedine, Lubiprostone, Naloxegol - Opioid-induced Constipation | Recruiting | BioDelivery Sciences International | 34532 | 2019-01-04 | 2026-09-30 | |
| Efficacy and Safety of Naldemedine in Treating Opioid-induced Constipation Naldemedine, Placebo - Opioid-induced Constipation | Phase 3 | Completed | Shionogi | 553 | 2013-11-04 | 2017-05-30 |
| Long Term Safety of Naldemedine Naldemedine, Placebo - Opioid-induced Constipation | Phase 3 | Completed | Shionogi | 1246 | 2013-09-24 | 2018-04-18 |
| Efficacy and Safety of Naldemedine in the Treatment of Opioid-induced Constipation Naldemedine, Placebo - Opioid-induced Constipation | Phase 3 | Completed | Shionogi | 547 | 2013-08-29 | 2017-05-30 |
| A Study of Naldemedine (S-297995) for the Treatment of Opioid-Induced Constipation in Adults With Non-Malignant Chronic Pain Receiving Opioid Therapy Placebo, Naldemedine - Opioid-induced Constipation | Phase 2 | Completed | Shionogi | 244 | 2011-08-17 | 2017-06-26 |
| Study to Evaluate the Safety and Efficacy of Naldemedine (S-297995) for the Treatment of Opioid-Induced Bowel Dysfunction in Subjects With Chronic Pain Naldemedine, Placebo - Opioid Induced Bowel Dysfunction | Phase 2 | Completed | Shionogi | 72 | 2010-05-19 | 2017-05-30 |
Opioid-Induced Constipation (9) · Constipation (2) · Chronic Pain (1) · Nausea (1) · Neoplasms (1) · Pancreatitis (1) · Vomiting (1)
Shionogi (7) · Asbjørn Mohr Drewes (2) · BioDelivery Sciences International (1) · International University of Health and Welfare (1) · Professor Monique A. H. Steegers (1)
United States (7) · Denmark (3) · Austria (2) · Czechia (2) · France (2) · Germany (2) · Italy (2) · Japan (2) · Poland (2) · Spain (2) · Sweden (2) · United Kingdom (2) · Albania (1) · Armenia (1) · Australia (1)
Stephen Lanes (1)
PMID 32086791, PMID 32280263, PMID 34295186, PMID 28576452, PMID 31145214, PMID 33965574, PMID 34377150, PMID 28371937, PMID 37127657, PMID 41553774, PMID 42468954
2019 (1), 2023 (1)