Clinical trials: 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
OIC
ALK37-007: Evaluation of Safety and Efficacy of ALKS 37 (RDC-1036) in Adults With Opioid-induced Constipation (OIC)
The purpose of this study is to evaluate the safety and efficacy of ALKS 37 when administered daily to adults with OIC.
- Trial name
- NCT01418092
- Testing
- ALKS 37
- Where
- 13 sites in United States
- Volunteers
- 91 people
- Sponsor
- Alkermes, 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
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
Study of Methylnaltrexone in Opioid-Induced Constipation Patients
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.
- Trial name
- NCT02574819
- Testing
- Methylnaltrexone (MNTX)
- Where
- 12 sites in China
- Volunteers
- 198 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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
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
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.
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.
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
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
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
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 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 Single-arm, Study to Assess the Effect and Tolerability of Standardised Laxative Therapy (SLT) for the Reversal of Opioid-induced Constipation (OIC).
The main purpose of this study is to assess how effective and tolerable the country specific clinical practice guidelines of SLTs are for UK, France and Sweden are.
- Trial name
- NCT01957046
- Testing
- Laxative
- Where
- Sweden
- Volunteers
- 117 people
- Sponsor
- Mundipharma Research GmbH & Co KG
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
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 (OIC)
Assessment of Long-term Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation
The purpose of this study is to evaluate the long-term safety and tolerability of NKTR-118 treatment of opioid-induced constipation (OIC) in patients with non-cancer-related pain.
- Trial name
- NCT01336205
- Testing
- NKTR-118, Usual care
- Where
- 169 sites in United States
- Volunteers
- 844 people
- Sponsor
- AstraZeneca
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
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