Clinical trials: Opioid-Induced Constipation
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
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
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
To Evaluate Patient Preference of Movantik and Polyethylene Glycol 3350 for Opioid Induced Constipation
The purpose of this study is to determine whether patients with opioid induced constipation prefer treatment with naloxegol (Movantik) or with Polyethylene Glycol 3350.
- Trial name
- NCT03060512
- Testing
- Polyethylene Glycol 3350, Movantik
- Where
- 53 sites in United States
- Volunteers
- 276 people
- Sponsor
- AstraZeneca
Neoplasms, Constipation
Methylnaltrexone for Opioid-induced Constipation in Cancer Patients
The purpose of this study is to evaluate the efficacy of methylnaltrexone in relieving opioid-induced constipation in cancer patients at various stages of disease.
- Conditions
- Neoplasms, Constipation, Opioid-Related Disorders
- Trial name
- NCT01004393
- Testing
- Methylnaltrexone bromide
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- University of Vermont
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
Constipation, Impaction, and Bowel Obstruction, Unspecified Adult Solid Tumor, Protocol Specific
Naloxone in Treating Constipation in Patients Who Are Receiving Opioids for Chronic Pain
RATIONALE: Naloxone may be effective in treating constipation that may be caused by opioid pain medications such as morphine. PURPOSE: Phase III trial to determine the effectiveness of naloxone in relieving constiption in…
- Trial name
- NCT00020605
- Testing
- naloxone hydrochloride
- Where
- United States
- Sponsor
- Dana-Farber Cancer Institute
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
Constipation, Bowel Dysfunction
Study Of Alvimopan Drug For Treatment Of Constipation Due To Prescription Pain Medication
A multicenter study to evaluate the effectiveness and safety of multiple dosage regimens of an investigational drug for the treatment of constipation due to prescription pain medication in subjects with cancer pain.
- Trial name
- NCT00101998
- Testing
- alvimopan
- Where
- 162 sites in United States, Argentina and 24 more
- Volunteers
- 233 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Constipation Drug Induced
Methylnaltrexone vs Naloxegol in the Treatment of Opioid-Induced Constipation
The purpose of this study is to compare the efficacy of subcutaneous versus oral mu-opioid receptor antagonist therapy in opioid induced constipation that is refractory to other bowel regimens.
- Trial name
- NCT03523520
- Testing
- Methylnaltrexone Bromide 150 mg Oral Tablet, Methylnaltrexone Bromide 12 MG/0.6 ML Subcutaneous Solution [RELISTOR]_#1, Naloxegol 25 MG Oral Tablet
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- University of Missouri-Columbia
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
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.
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, 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
ALK37-005: A Study of ALKS 37 (RDC-1036) in Adults With Opioid-induced Constipation (OIC)
The purpose of this study is to evaluate the safety, tolerability and efficacy of ALKS 37 when administered daily for 4 weeks to adults with Opioid-induced Constipation (OIC).
- Trial name
- NCT01382797
- Testing
- ALKS 37
- Where
- 20 sites in United States
- Volunteers
- 157 people
- Sponsor
- Alkermes, Inc.
Low Back Pain
A Study of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess Analgesic Efficacy and Management of Opioid-induced Constipation (OIC) in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain
The primary objective is to assess the efficacy of oxycodone/naloxone controlled-release tablets (OXN) for the management of opioid-induced constipation (OIC) compared with oxycodone controlled-release tablets (OXY) in subjects…
- Trial name
- NCT01427283
- Testing
- Oxycodone/Naloxone controlled-release, Oxycodone HCl controlled-release
- Where
- 149 sites in United States
- Volunteers
- 450 people
- Sponsor
- Purdue Pharma LP
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
Postoperative Pain, Opioid Related Disorders
A Comparison of PR Oxycodone/Naloxone and PR Oxycodone After Cardiac Surgery
The aim of the study is to describe the effects of oxycodone/naloxone combination in comparison to oxycodone for the treatment of postoperative pain in patients undergoing cardiac surgery.
- Trial name
- NCT01374763
- Testing
- Oxycodone, Prolonged-release oxycodone/naloxone
- Where
- Finland
- Volunteers
- 165 people
- Sponsor
- Kati Järvelä
Opioid-induced Constipation
A Study of Naldemedine (S-297995) for the Treatment of Opioid-Induced Constipation in Adults With Non-Malignant Chronic Pain Receiving Opioid Therapy
The purpose of this study is to determine efficacy and safety of naldemedine for the treatment of opioid-induced constipation in adults with non-malignant chronic pain receiving opioid therapy for ≥ 3 months.
- Trial name
- NCT01443403
- Testing
- Naldemedine
- Where
- 49 sites in United States
- Volunteers
- 244 people
- Sponsor
- Shionogi
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.