Naldemedine

DRUG10 trials

Conditions

ConstipationOpioid Induced Bowel DysfunctionOpioid-Induced Bowel DysfunctionOpioid-Induced Constipation (OIC)Opioid-induced ConstipationPostoperative Gastrointestinal Dysfunction

Phase 1

Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids

RecruitingNCT05588323

ShionogiOpioid-Induced Constipation (OIC)

Start: 2023-01-04End: 2026-06-15Target: 24Updated: 2025-04-20

Phase 2

Study to Evaluate the Safety and Efficacy of Naldemedine (S-297995) for the Treatment of Opioid-Induced Bowel Dysfunction in Subjects With Chronic Pain

CompletedNCT01122030

ShionogiOpioid Induced Bowel Dysfunction

Start: 2010-05-19End: 2011-03-22Updated: 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

CompletedNCT01443403

ShionogiOpioid-induced Constipation

Start: 2011-08-17End: 2012-08-22Updated: 2017-06-26

A Study of Naldemedine in Participants Undergoing Surgeries That Include a Bowel Resection or Bowel Transection

TerminatedNCT04355169

ShionogiPostoperative Gastrointestinal Dysfunction

Start: 2020-11-06End: 2021-01-04Updated: 2022-01-18

The Effect of Naldemedine on Opioid-induced Bowel Dysfunction

RecruitingNCT06334198

Asbjørn Mohr DrewesConstipation, Opioid-Induced Bowel Dysfunction

Start: 2024-03-12End: 2025-03-31Target: 20Updated: 2024-03-28

Phase 3

Long Term Safety of Naldemedine

CompletedNCT01965652

ShionogiOpioid-induced Constipation

Start: 2013-09-24End: 2016-01-12Updated: 2018-04-18

Efficacy and Safety of Naldemedine in the Treatment of Opioid-induced Constipation

CompletedNCT01965158

ShionogiOpioid-induced Constipation

Start: 2013-08-29End: 2015-01-22Updated: 2017-05-30

Efficacy and Safety of Naldemedine in Treating Opioid-induced Constipation

CompletedNCT01993940

ShionogiOpioid-induced Constipation

Start: 2013-11-04End: 2015-06-09Updated: 2017-05-30

Phase 4

Prophylactic Use of Naldemedine on Opioid-induced Nausea and Vomiting in Patients With Cancer: POSEIDON Study

RecruitingNCT07038551

International University of Health and WelfareOpioid-Induced Constipation (OIC)

Start: 2025-06-06End: 2027-09-30Target: 120Updated: 2025-07-02

Unknown Phase

Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation

RecruitingNCT03720613

BioDelivery Sciences InternationalOpioid-induced Constipation

Start: 2019-01-04End: 2030-11-01Target: 34532Updated: 2025-02-12

2021-08-058 citations

Naldemedine Improves Patient-Reported Outcomes of Opioid-Induced Constipation in Patients with Chronic Non-Cancer Pain in the COMPOSE Phase 3 Studies

Journal of Pain Research2021-07-0112 citations

Naldemedine is effective in the treatment of opioid-induced constipation in patients with chronic non-cancer pain who had a poor response to laxatives

Therapeutic Advances in Gastroenterology2021-01-013 citations

Safety and Efficacy of Naldemedine for the Treatment of Opioid-Induced Constipation in Patients with Chronic Non-Cancer Pain Receiving Opioid Therapy: A Subgroup Analysis of Patients ≥ 65 Years of Age.

2020-04-0117 citations

<p>A Renal Impairment Subgroup Analysis of the Safety and Efficacy of Naldemedine for the Treatment of Opioid-Induced Constipation in Patients with Chronic Non-Cancer Pain Receiving Opioid Therapy</p>

Journal of Pain Research2020-03-0110 citations

Naldemedine Is Effective in the Treatment of Opioid-Induced Constipation in Chronic Non-Cancer Pain in Subjects With or Without Inadequate Response to Laxatives

The American Journal of Gastroenterology2018-10-011 citations

A Phase 2b, Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Naldemedine for the Treatment of Opioid-Induced Constipation in Patients with Chronic Noncancer Pain.

2017-12-0150 citations

Effect of Naldemedine on Frequency of Spontaneous Bowel Movements and Associated Symptoms

The American Journal of Gastroenterology2017-10-01

Naldemedine versus placebo for opioid-induced constipation (COMPOSE-1 and COMPOSE-2): two multicentre, phase 3, double-blind, randomised, parallel-group trials.

2017-05-3099 citations

Onset of Action of Naldemedine in the Treatment of Opioid-Induced Constipation in Patients with Chronic Non-Cancer Pain: Results from Two Randomized, Placebo-Controlled Phase 3 Trials

The American Journal of Gastroenterology2016-10-011 citations

Naldemedine

Sponsors

Conditions

Phase 1

Phase 2

Phase 3

Phase 4

Unknown Phase

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