Clinical trials: Opioid-induced Constipation (OIC)
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
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
Naloxone HCl PR Tablets in Patients With Opioid Induced Constipation
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.
- Trial name
- Naxos (NCT03687268)
- Testing
- Naloxone HCl PR tablets
- Where
- 104 sites in Bulgaria, Czechia and 7 more
- Volunteers
- 1,500 people
- Sponsor
- Develco Pharma Schweiz AG
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
Compassionate Use Study of Methylnaltrexone
This is an open label compassionate use study of subcutaneously administered methylnaltrexone (MNTX) in participants with advance medical illness and opioid-induced constipation.
- Trial name
- NCT01368562
- Testing
- Methylnaltrexone
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Bausch Health Americas, Inc.
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
Low Back Pain
Analgesic Efficacy and Management of Opioid-induced Constipation (OIC) for Uncontrolled Moderate - Severe Low Back Pain
The primary objective is to assess the efficacy of oxycodone/naloxone (OXN) for the management of opioid-induced constipation (OIC) compared to oxycodone controlled-release tablets (OXY) in subjects with moderate to severe low…
- Trial name
- NCT01427270
- Testing
- Oxycodone/Naloxone controlled-release, Oxycodone HCl controlled-release
- Where
- 194 sites in United States, Czechia and 2 more
- Volunteers
- 455 people
- Sponsor
- Purdue Pharma LP
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 Constipation
Efficacy and Safety of Naldemedine in Treating Opioid-induced Constipation
The purpose of this study is to evaluate the efficacy and safety of naldemedine in the treatment of opioid-induced constipation (OIC) in adults with non-malignant chronic pain who are not using laxatives.
- Trial name
- NCT01993940
- Testing
- Naldemedine
- Where
- 49 sites in United States
- Volunteers
- 553 people
- Sponsor
- Shionogi
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
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 (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
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 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
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
Constipation
Study Evaluating Subcutaneous MOA-728 for the Treatment of Opioid-Induced Constipation (OIC) in Subjects With Chronic Non-Malignant Pain
The primary purpose of the protocol is to evaluate the safety, efficacy, and tolerability of subcutaneous MOA-728 versus placebo in subjects with chronic non-malignant pain who have Opioid-Induced Constipation (OIC).
- Trial name
- NCT00529087
- Testing
- N-methylnaltrexone bromide (MOA-728)
- Where
- 78 sites in United States
- Volunteers
- 460 people
- 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 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 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
Assessing a Stool Symptom Screener in Patients With Chronic Opioid-Induced Constipation
This qualitative research is to assess the validity of the stool symptom screener that will be used in patients with chronic opioid-induced constipation to determine the adequacy of their response to laxatives.
- Trial name
- NCT01645371
- Volunteers
- 79 people
- Sponsor
- AstraZeneca