Clinical trials: Opioid-Induced Constipation
Opioid-induced Constipation
Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation
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…
- Trial name
- NCT03720613
- Testing
- Naldemedine, Lubiprostone, Naloxegol
- Where
- United States
- Volunteers
- 34,532 people
- Sponsor
- BioDelivery Sciences International
Opioid-Induced Constipation (OIC)
Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids
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…
- Trial name
- NCT05588323
- Testing
- Naldemedine
- Where
- 16 sites in Albania, Armenia and 6 more
- Volunteers
- 24 people
- Sponsor
- Shionogi
Healthy, Opioid-induced Constipation
A Multiple Dose Study of TD-1211 in Healthy Volunteers and Patients With Opioid-Induced Constipation
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of TD-1211 in healthy subjects and activity in subjects with opioid-induced constipation (OIC).
- Trial name
- NCT01040637
- Testing
- TD-1211
- Where
- 3 sites in United States
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Glycyx Therapeutics
Opioid-induced Constipation (OIC)
A Study to Assess the Safety, Tolerability and Clinical Activity of TD-1211 in Patients With Opioid-Induced Constipation
A dose-escalation study to assess the safety, tolerability and clinical activity of TD-1211 in patients with opioid-induced constipation.
- Trial name
- NCT01333540
- Testing
- TD-1211
- Where
- United States
- Volunteers
- 69 people
- Sponsor
- Glycyx Therapeutics
Opioid Induced Constipation
A Study of TD-1211 in Subjects With Opioid-Induced Constipation (OIC)
A Single-Blind, Pilot Study to Determine the Tolerability and Safety of TD-1211 in Subjects with Opioid-Induced Constipation
- Trial name
- NCT01401985
- Testing
- TD-1211
- Where
- United States
- Volunteers
- 95 people
- Sponsor
- Glycyx Therapeutics
Opioid Induced Constipation
A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of TD-1211 in Subjects With Opioid-Induced Constipation
A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of TD-1211 in Subjects with Opioid-Induced Constipation
- Trial name
- NCT01459926
- Testing
- TD-1211
- Where
- United States
- Volunteers
- 217 people
- Sponsor
- Glycyx Therapeutics
Constipation
TD-1211 Single-Dose Study in Elderly and Young Healthy Subjects
The purpose of this study is to measure the way in which TD-1211 is absorbed and eliminated by the body and to evaluate whether it is safe and well tolerated.
- Trial name
- NCT01655771
- Testing
- TD-1211 Dose 1, TD-1211 Dose 2
- Where
- United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Glycyx Therapeutics
OIC
TD-1211 IV/Oral Mass Balance Study
The purpose of this study is to determine TD-1211 is processed by the body.
- Trial name
- NCT01702194
- Testing
- TD-1211 IV [C14], TD-1211 PO [C14]
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Glycyx Therapeutics
Opioid-Induced Constipation
Safety and Preliminary Efficacy of BGP345A in Constipation Due to Opioid-based Medications
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.
- Trial name
- OIC1 (NCT05133076)
- Testing
- Lactobacillus gasseri BGP345A
- Where
- 4 sites in France
- Volunteers
- 14 people
- Sponsor
- BioGaia Pharma AB
Opioid Induced Constipation
Naloxegol Drug Utilization Post Authorisation Safety Study
This post-authorization observational safety study determines the characteristics of patients prescribed naloxegol at time of first prescription and treatment patterns of naloxegol in follow-up in the United Kingdom (UK), Norway…
- Trial name
- NCT02813148
- Testing
- Naloxegol
- Where
- 4 sites in Germany, Norway and 2 more
- Volunteers
- 17,254 people
- Sponsor
- Kyowa Kirin Pharmaceutical Development Ltd
Opioid Induced Constipation
Naloxegol Health Outcome Post Authorisation Safety Study
This post-authorization observational safety study (PASS) monitors clinically important identified and potential risks within a cohort of patients treated with naloxegol, including the occurrence of bowel perforation, acute…
- Trial name
- NCT02813369
- Testing
- naloxegol, non-PAMORA laxative
- Where
- 2 sites in Netherlands, United Kingdom
- Volunteers
- 10,000 people
- Sponsor
- Kyowa Kirin Pharmaceutical Development Ltd
Constipation, Signs and Symptoms, Digestive
Phase I Pharmacokinetics and Safety Study of Naloxegol in Paediatric OIC Patients
To characterize the pharmacokinetics (PK) of naloxegol after single oral dose and through population PK in paediatric patients with opioid induced constipation (OIC) or at risk of OIC.
- Trial name
- NCT02099591
- Testing
- Naloxegol
- Where
- 16 sites in Denmark, Israel and 3 more
- Volunteers
- 61 people
- Sponsor
- Kyowa Kirin Pharmaceutical Development Ltd
Opioid Induced Constipation
Real World Observational Study of Naloxegol for Patients With Cancer Pain Diagnosed With OIC.
This is a single-arm, open label, multinational, multicentre, prospective, real world observational study of Naloxegol in adult subjects with Opioid Induced Constipation (OIC) in patients receiving Naloxegol in routine clinical…
- Trial name
- NACASY (NCT03638440)
- Testing
- Naloxegol
- Where
- 10 sites in Denmark, Finland and 8 more
- Volunteers
- 183 people
- Sponsor
- Kyowa Kirin Pharmaceutical Development Ltd
Opioid Induced Constipation
Naloxegol US PMR CV Safety.
The overall research goal for this study is to provide additional data to characterize the safety of naloxegol in patients aged 18 years and older who do not have a diagnosis of cancer and who are treated with opioids chronically
- Trial name
- NCT02813356
- Testing
- naloxegol, non-PAMORA
- Where
- 2 sites in United States
- Volunteers
- 8,800 people
- Sponsor
- Valinor Pharma LLC
Non-cancer Pain, Opioid Induced Constipation
Prucalopride Effects on Subjects With Chronic Non-cancer Pain Suffering From Opioid Induced Constipation
The study will evaluate the efficacy, safety and tolerability of prucalopride over 12 weeks of treatment in subjects aged 18 years and older with chronic non-cancer pain, suffering from opioid induced constipation.
- Trial name
- OIC (NCT01117051)
- Testing
- prucalopride
- Where
- Belgium
- Volunteers
- 174 people
- Sponsor
- Shire
Opioid-induced Bowel Dysfunction
Opioid-induced Bowel Dysfunction (OBD) Pivotal Assessment of Lubiprostone (OPAL)
The primary purpose of the study is to evaluate the efficacy and safety of lubiprostone administration in subjects with Opioid-induced Bowel Dysfunction.
- Trial name
- NCT01298219
- Testing
- Lubiprostone
- Where
- 142 sites in United States, Belgium and 5 more
- Volunteers
- 439 people
- Sponsor
- Sucampo Pharma Americas, LLC
Opioid-Induced Bowel Dysfunction
Opioid-induced Bowel Dysfunction: Long-Term Assessment of Lubiprostone
The purpose of this study is to evaluate the long-term safety and efficacy of lubiprostone administration in participants with opioid-induced bowel dysfunction.
- Trial name
- NCT00620061
- Testing
- Lubiprostone 24
- Where
- 123 sites in United States, Canada
- Volunteers
- 439 people
- Sponsor
- Sucampo Pharma Americas, LLC
Constipation
Study Evaluating the Efficacy and Safety of Subcutaneous Methylnaltrexone (MOA-728) for the Treatment of Opioid-Induced-Constipation
The primary purpose of this study is to evaluate the safety, efficacy, and tolerability of subcutaneous (injection beneath the skin) MOA-728 versus placebo in adult Asian subjects with opioid-induced constipation associated with…
- Trial name
- NCT00936884
- Testing
- Methylnaltrexone
- Where
- 6 sites in South Korea, Taiwan
- Volunteers
- 50 people
- Sponsor
- Bausch Health Americas, Inc.
Opioid-Induced Bowel Dysfunction
Opioid-induced Bowel Dysfunction: Pivotal Assessment of Lubiprostone
The primary purpose of this study is to evaluate the efficacy and safety of lubiprostone administration in patients with Opioid-induced Bowel Dysfunction.
- Trial name
- OPAL (NCT00595946)
- Testing
- Lubiprostone
- Where
- 95 sites in United States, Canada
- Volunteers
- 439 people
- Sponsor
- Sucampo Pharma Americas, LLC
Opioid-Induced Bowel Dysfunction
Opioid-induced Bowel Dysfunction Pivotal Assessment of Lubiprostone
The primary purpose of this study is to evaluate the efficacy and safety of lubiprostone administration in patients with opioid-induced bowel dysfunction (OBD).
- Trial name
- OPAL (NCT00597428)
- Testing
- Lubiprostone
- Where
- 114 sites in United States, Canada
- Volunteers
- 437 people
- Sponsor
- Sucampo Pharma Americas, LLC