Clinical trials: Opioid-Induced Constipation (OIC)
Opioid Induced Constipation (OIC)
A Phase 2, Double-Blind, Multiple-Dose Escalation Study to Evaluate NKTR-118 (Oral PEG-Naloxol) in Patients With Opioid-Induced Constipation (OIC)
Study (07-IN-NX003) is a Phase 2, multi-center, placebo-controlled, double-blind, randomized, dose-escalation trial. It is designed to investigate the safety, efficacy and tolerability of NKTR-118 (PEG-naloxol) in patients with…
- Trial name
- NCT00600119
- Testing
- NKTR-118
- Where
- 33 sites in United States
- Volunteers
- 207 people
- Sponsor
- AstraZeneca
Opioid-Induced Constipation
Safety of Subcutaneous Methylnaltrexone for Opioid-Induced Constipation in Patients With Advanced Illness
This is an open-label, multicenter extension of study 3200K1-4000-WW that will evaluate the safety of methylnaltrexone. This drug will be administered by subcutaneous injection and will be tested in late stage, advanced illness…
- Trial name
- NCT00672139
- Testing
- Methylnaltrexone bromide
- Where
- 46 sites in United States, Australia and 8 more
- Volunteers
- 156 people
- Sponsor
- Bausch Health Americas, Inc.
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)
A 12-week Extension of the Phase III Study (D3820C00004) to Assess the Effect and Safety of NKTR-118 in Patients With Non-cancer-related Pain and Opioid-induced Constipation
The purpose of this study is to evaluate the effect and safety of NKTR-118 treatment of opioid-induced constipation in patients with non-cancer-related pain over a 6-month period.
- Trial name
- NCT01395524
- Testing
- NKTR-118
- Where
- 116 sites in United States, Australia and 2 more
- Volunteers
- 302 people
- Sponsor
- AstraZeneca
Constipation, Pain
Efficacy of Oxycodone/Naloxone(OXN), Versus Oxycodone (OXY), for the Reduction of Intensity of Opioid-induced Constipation in Pain Patients
The primary objective of this trial is to study the efficacy of oxycodone/naloxone prolonged release tablets (OXN PR), compared to oxycodone prolonged release tablets (Oxy PR), for the reduction of the intensity of opioid-induced…
- Trial name
- OXN3505 (NCT01014559)
- Testing
- Oxycodone Naloxone, Oxycodone PR Tablets
- Where
- France
- Volunteers
- 225 people
- Sponsor
- Mundipharma SAS
Opioid-Induced Constipation
Study Evaluating Safety & Efficacy of Subcutaneous Methylnaltrexone on Opioid-Induced Constipation in Cancer Subjects
This purpose of this study is to evaluate the safety and effectiveness of a subcutaneous (injection beneath the skin) form of methylnaltrexone in subjects who have cancer-related pain and constipation from taking opioids.
- Trial name
- NCT00858754
- Testing
- methylnaltrexone
- Where
- 8 sites in United States, Canada and 2 more
- Sponsor
- Bausch Health Americas, Inc.
Opioid Induced Constipation
Open Label, Healthy Volunteers, Bioequivalence Study With Naloxegol
The purpose of this study is to demonstrate the Bioequivalence, assess food administration on the Pharmacokinetics with naloxegol.
- Trial name
- NCT01623609
- Testing
- Naloxegol
- Where
- United Kingdom
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Opioid-Induced Constipation
A Study of Oral Methylnaltrexone (MNTX) for the Treatment of Opioid-Induced Constipation (OIC) in Participants With Chronic, Non-Malignant Pain
MNTX 3201 is a Phase 3, international, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of oral MNTX for the treatment of opioid induced constipation in…
- Trial name
- NCT01186770
- Testing
- Methylnaltrexone
- Where
- 2 sites in United States
- Volunteers
- 804 people
- Sponsor
- Bausch Health Americas, Inc.
Opioid-Induced Constipation
Safety Study of CB-5945 for the Treatment of Opioid-Induced Constipation
The purpose of this study is to evaluate the long-term safety and tolerability of CB-5945 for the treatment of opioid-induced constipation (OIC) in adults taking opioid therapy for chronic non-cancer pain.
- Trial name
- NCT01696643
- Testing
- CB-5945
- Volunteers
- 1,407 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Bowel Dysfunction
Methylnaltrexone in Patients With Opioid-Induced Bowel Dysfunction
This is a double-blind, randomized, parallel group, dose ranging study of subcutaneous methylnaltrexone to be conducted in patients with advanced medical illness and poorly controlled opioid induced constipation.
- Trial name
- NCT01367574
- Testing
- SC MNTX
- Where
- United States
- Volunteers
- 39 people
- Sponsor
- Bausch Health Americas, Inc.
Patients With Opioid Induced Constipation
Longitudinal Study of Patients With Opioid-Induced Constipation
This prospective hybrid longitudinal study was conducted in the United States (US), Canada, the United Kingdom (UK), and Germany.
- Trial name
- NCT01928953
- Where
- 30 sites in United States, Canada
- Volunteers
- 520 people
- Sponsor
- AstraZeneca
Opioid-induced Constipation
ALK37-003: A Study of RDC-1036 (ALKS 37) in Adults With Opioid-induced Constipation (OIC)
The purpose of this study is to assess the safety and tolerability of RDC-1036 (ALKS 37) in adults with opioid-induced constipation (OIC) following repeat dose administration
- Trial name
- NCT01100151
- Testing
- RDC-1036 (ALKS 37)
- Where
- 11 sites in United States
- Volunteers
- 60 people
- Sponsor
- Alkermes, Inc.
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
Safety and Efficacy of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain.
This study will evaluate the safety and efficacy of Tegaserod in opioid-induced constipation in patients with non-cancer pain. Patients who enter this study PRIOR to the core study (CHTF919N2201) interim analysis receive the…
- Trial name
- NCT00414024
- Testing
- Tegaserod
- Where
- 6 sites in United States, China and 4 more
- Volunteers
- 11 people
- Sponsor
- Novartis
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
Chronic Pain, Opioid Induced Constipation
Naloxone SR Capsules in Patients With Opioid Induced Constipation
For many patients taking opioids for pain relief one of the most distressing side effects is constipation. Naloxone is effective in the reversal of the effects of opioids and is used following opioid overdose.
- Trial name
- NCT00984334
- Testing
- Naloxone SR 5 mg capsules, Naloxone SR 10 mg capsules, Naloxone SR 20mg capsules
- Where
- 8 sites in Germany, United Kingdom
- Volunteers
- 40 people
- Sponsor
- S.L.A. Pharma AG
Opioid-Induced Constipation
Efficacy and Safety Study of CB-5945 for the Treatment of Opioid-Induced Constipation
The purpose of this study is to evaluate the safety and efficacy of CB-5945 for the treatment of opioid-induced constipation (OIC) in adults taking opioid therapy for chronic non-cancer pain.
- Trial name
- NCT01901302
- Testing
- CB-5945
- Volunteers
- 61 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
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
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 Constipation
Phase 2 Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of Linaclotide Administered to Patients With Opioid-Induced Constipation Receiving Chronic Opioid Treatment for Non-Cancer Pain
The purpose of this study was to evaluate the safety and efficacy of linaclotide for the treatment of opioid-induced constipation (OIC), in adults receiving stable opioid treatment for chronic non-cancer pain that has been…
- Trial name
- NCT02270983
- Testing
- Linaclotide 145 micrograms, Linaclotide 290 micrograms
- Where
- 77 sites in United States
- Volunteers
- 254 people
- Sponsor
- Forest Laboratories