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Opioid-induced Constipation clinical trials

View clinical trials related to Opioid-induced Constipation.

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NCT ID: NCT06334198 Recruiting - Constipation Clinical Trials

The Effect of Naldemedine on Opioid-induced Bowel Dysfunction

Start date: March 12, 2024
Phase: Phase 2
Study type: Interventional

Opioid-induced bowel dysfunction is a frequent condition during opioid therapy for chronic pain. Indeed, up to 90% of people on opioid treated patients experience constipation. Standard laxative treatment is often ineffective in opioid-induced constipation, but peripheral acting mu-receptor antagonists (PAMORAs) have the potential to block the effects of opioids in the gastrointestinal tract while preserving the central analgesic effect. In this study, we will investigated the effects of Naldemedine in preventing the development of opioid-induced bowel dysfunction and constipation during treatment with tramadol

NCT ID: NCT05588323 Recruiting - Clinical trials for Opioid-Induced Constipation (OIC)

Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids

Start date: January 4, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the pharmacokinetic (PK) profile of naldemedine and nor-naldemedine after a single oral dose of naldemedine in pediatric participants who are receiving or about to receive opioids.

NCT ID: NCT05216328 Recruiting - Clinical trials for Constipation, Opioid-Induced

Prevention of Opioid-induced Constipation in Patients With Advanced Cancer

OMAMA
Start date: December 2, 2022
Phase: Phase 4
Study type: Interventional

More than 70% of patients with cancer in the palliative phase have pain that often requires treatment with opioids (morphine-like agents). Constipation occurs in 59% of patients treated with opioids. Opioid-induced constipation (OIC) has consequences that range from daily discomfort with social insecurity and disability to intestinal obstruction. It leads to limitations in self-management, a reduced quality of life and a risk of the need for more care. In the guideline "Diagnosis and treatment of pain in patients with cancer" it is recommended to start preventively with an osmotic laxative such as macrogol/electrolytes or magnesium hydroxide when starting opioids. Macrogol/electrolytes has been proven to be effective for OIC, but is sometimes perceived by patients as unpleasant due to its taste. Magnesium hydroxide, which is less commonly prescribed for OIC, has a neutral taste. Although it is mentioned in the guideline, it is not studied for the treatment of OIC and also not officially registered for this. To support the advice of the guideline and to prove that a choice is possible, it is important to investigate whether there are differences in effectiveness and/or side effects between macrogol/electrolytes and magnesium hydroxide in the prevention of OIC. The aim of this study is to compare macrogol/electrolytes with magnesium hydroxide in the prevention of opioid-induced constipation in patients with cancer in the palliative (incurable) phase, who start opioids because of pain. The choice of laxative is determined by drawing lots (randomisation). After two weeks, its effect will be assessed and will be presented as the percentage of patients who have not developed constipation after starting opioids. If the laxative, as assigned by lot, is described as satisfactory by the patient, the patient can continue with the drug that the patient used, after the study through regular prescription. The investigators will ask the patients in the study about their satisfaction with the laxative used, any side effects and the degree of pain. Furthermore, the appeal to care for possible constipation will be examined. Because the best attainable quality of life in the palliative phase is the objective of all care, the investigators will also measure this perceived quality with a questionnaire in this study. The results of this study will lead to the best achievable prevention of opioid constipation in patients with cancer in the palliative phase.

NCT ID: NCT05149833 Recruiting - Clinical trials for Opioid-Induced Constipation

European Study of Opioid Induced Constipation

E-StOIC
Start date: September 16, 2021
Phase:
Study type: Observational [Patient Registry]

Constipation is common (40-90%) in advanced cancer patients , and has a significant negative impact on quality of life. The aetiology of constipation is often multifactorial in advanced cancer patients. However, it is well recognised that opioid analgesics are a common cause of constipation in this group. The prevalence of opioid-induced constipation (OIC) is stated to be 40-70%, although a recent large study reported an even higher figure. OIC has been reported to exceed pain in terms of distress caused, and studies have found that some patients choose to reduce or discontinue opioid medication in order to attempt to better control constipation. Moreover, OIC is associated with a variety of physical (gastrointestinal, systemic), psychological and social problems.

NCT ID: NCT05133076 Recruiting - Clinical trials for Opioid-Induced Constipation

Safety and Preliminary Efficacy of BGP345A in Constipation Due to Opioid-based Medications

OIC1
Start date: January 20, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess safety and preliminary efficacy of BGP345A in patients with constipation due to the use of opioid-based medications for the management of chronic non cancer pain.

NCT ID: NCT03720613 Recruiting - Clinical trials for Opioid-induced Constipation

Risk of Major Adverse Cardiovascular Events for Naldemedine and Other Medications for Opioid Induced Constipation in Adults With Chronic Non-Cancer Pain

Start date: January 4, 2019
Phase:
Study type: Observational

The research objective is to characterize the risk of a major adverse cardiovascular event (MACE) among new users of naldemedine versus new users of lubiprostone and new users of naloxegol as comparator opioid induced constipation (OIC) medications.

NCT ID: NCT03687268 Recruiting - Clinical trials for Opioid-Induced Constipation

Naloxone HCl PR Tablets in Patients With Opioid Induced Constipation

Naxos
Start date: July 31, 2017
Phase: Phase 3
Study type: Interventional

Prospective, randomised, double-blind, double-dummy, placebo-controlled, parallel-group, multi-centre, phase III trial of Naloxone HCl PR Tablets (12 mg and 24 mg) administered twice daily. The trial will consist of four phases: Screening phase (Week -4 to Week -3): Confirmation phase (Week -2 to Week -1): Double-blind treatment phase Follow-up phase (Week 13-14):

NCT ID: NCT03316859 Recruiting - Constipation Clinical Trials

Naloxegol and Opioid-induced Constipation

Start date: November 6, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

This is a double-blind, randomized, placebo-controlled trial to examine the effectiveness of adding one 25mg dose of naloxegol to the cardiac surgery pre-operative regimen.

NCT ID: NCT02574819 Recruiting - Clinical trials for Opioid-induced Constipation

Study of Methylnaltrexone in Opioid-Induced Constipation Patients

Start date: April 2015
Phase: Phase 2/Phase 3
Study type: Interventional

This is a multicenter, randomized, double-blind , placebo-controlled trail to investigate the safety and efficacy of subcutaneous methylnaltrexone for treating opioid-induced constipation in patients with advanced illness.

NCT ID: NCT01050595 Recruiting - Clinical trials for Opioid-induced Constipation

Methylnaltrexone for Treatment of Opiate-Induced Constipation in the Intensive Care Unit

MOVE-IT
Start date: December 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if there will be a significantly higher incidence of a bowel movement with methylnaltrexone vs. placebo within 4 hours +- 45 minutes with decreased need for rescue medications in the intensive care unit in patients with opioid-induced constipation. Patients will also be managed with an aggressive bowel management protocol.