Clinical trials: Tolerability
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
TTR-mediated Amyloidosis
Safety and Tolerability of Patisiran (ALN-TTR02) in Transthyretin (TTR) Amyloidosis
This was a multiple dose, dose escalation study designed to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of patisiran (ALN-TTR02) in participants with transthyretin (TTR) mediated amyloidosis (ATTR).
- Trial name
- NCT01617967
- Testing
- Patisiran
- Where
- 10 sites in United States, Brazil and 5 more
- Volunteers
- 29 people
- Sponsor
- Alnylam Pharmaceuticals
Pulmonary Arterial Hypertension
Open-label, Clinical Study to Evaluate the Safety and Tolerability of TreT in Subjects With PAH Currently Using Tyvaso
This was a Phase 1b safety and tolerability single-sequence study in which PAH subjects on a stable regimen of Tyvaso switched to a corresponding dose of TreT.
- Trial name
- BREEZE (NCT03950739)
- Testing
- Treprostinil Inhalation Powder
- Where
- 16 sites in United States
- Volunteers
- 51 people
- Sponsor
- United Therapeutics
Exocrine Pancreatic Insufficiency
Safety, Tolerability and Fat Absorption Using Enteral Feeding In-line Enzyme Cartridge (Relizorb)
Protocol ALCT-0000497 is a multicenter safety, tolerability and fat absorption study that anticipates enrolling 35 male and female subjects (pediatric and adult) with cystic fibrosis.
- Trial name
- NCT02598128
- Testing
- RELiZORB
- Where
- 11 sites in United States
- Volunteers
- 34 people
- Sponsor
- Alcresta Therapeutics, Inc.
Spinal and Bulbar Muscular Atrophy
Safety, Tolerability, and Efficacy of BVS857 in Patients With Spinal and Bulbar Muscular Atrophy
The purpose of this study was to determine if BVS857 is safe, tolerable and increases thigh muscle thickness in patients with spinal bulbar and muscular atrophy (SBMA).
- Trial name
- NCT02024932
- Testing
- BVS857
- Where
- 6 sites in United States, Denmark and 2 more
- Volunteers
- 37 people
- Sponsor
- Novartis Pharmaceuticals
Back Pain, Low Back Pain
Tapentadol Prolonged Release (PR) Versus Oxycodone/Naloxone Prolonged Release in Severe Chronic Low Back Pain With a Neuropathic Component.
This was a clinical effectiveness trial designed to compare the effectiveness, safety, and tolerability of treatment with tapentadol prolonged release with that of oxycodone/naloxone prolonged release in non-opioid pre-treated…
- Conditions
- Back Pain, Low Back Pain, Neuropathic Pain
- Trial name
- NCT01838616
- Testing
- Tapentadol Prolonged Release, Oxycodone/Naloxone Prolonged Release
- Where
- 50 sites in Austria, Germany and 2 more
- Volunteers
- 367 people
- Sponsor
- Grünenthal GmbH
Skin and Subcutaneous Tissue Bacterial Infections, Gram-Positive Bacterial Infections
TNP-2092 to Treat Acute Bacterial Skin and Skin Structure Infection
The purpose of this study is to evaluate safety, tolerability, pharmacokinetic characteristics and efficacy of TNP-2092 in adults with ABSSSI suspected or confirmed to be caused by gram-positive pathogens.
- Trial name
- P2_ABSSSI (NCT03964493)
- Testing
- TNP-2092, Vancomycin
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- TenNor Therapeutics Limited
Asthma
A Study in Asthma Patients to Evaluate Efficacy, Safety and Tolerability of 14 Days Once Daily Inhaled Interferon Beta-1a After the Onset of Symptoms of an Upper Respiratory Tract Infection
A study to investigate if inhaled Interferon beta-1a is safe and tolerated, and can prevent or reduce the severity of asthma attacks when administered to asthma patients at the onset of symptoms of common cold or influenza
- Trial name
- INEXAS (NCT02491684)
- Testing
- Interferon beta-1a Nebuliser solution 48 μg/mL
- Where
- 35 sites in Argentina, Australia and 5 more
- Volunteers
- 121 people
- Sponsor
- AstraZeneca
Lysosomal Acid Lipase Deficiency, Wolman Disease
Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Sebelipase Alfa in Children With Growth Failure Due to Lysosomal Acid Lipase Deficiency
This was an open-label, repeat-dose, intra-participant dose-escalation study of SBC-102 (sebelipase alfa) in children with growth failure due to lysosomal acid lipase (LAL) Deficiency.
- Trial name
- NCT01371825
- Testing
- Sebelipase alfa (SBC-102)
- Where
- 7 sites in United States, Egypt and 3 more
- Volunteers
- 9 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Dose Finding Study
Safety, Tolerability and Pharmacokinetics of Escalating Single Doses of TAK-828 in Healthy Participants
The purpose of this study is to evaluate the safety and tolerability of single oral doses of TAK-828 in healthy non-Japanese and Japanese participants.
- Trial name
- NCT02706834
- Testing
- TAK-828
- Where
- 2 sites in United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Takeda
Anemia
A Study of Monthly Subcutaneous or Intravenous Mircera in Dialysis Patients With Chronic Renal Anaemia
This open label, single arm study will assess the efficacy for long-term maintenance of haemoglobin levels and the safety and tolerability of methoxy polyethylene glycol-epoetin beta [Mircera] in dialysis patients with chronic…
- Trial name
- NCT01156363
- Testing
- Dialysis, methoxy polyethylene glycol-epoetin beta [Mircera]
- Where
- 3 sites in Taiwan
- Volunteers
- 86 people
- Sponsor
- Hoffmann-La Roche
Pain
Evaluation of the Tolerability of Switching Subjects on Chronic ATC Opioid Therapy to Buprenorphine HCl Buccal Film
The primary aim of this study is to determine if chronic pain subjects on around-the-clock opioids who are receiving 100 to 220 mg oral morphine sulfate equivalent (MSE) can be safely transitioned on to buprenorphine…
- Trial name
- NCT01871285
- Testing
- Buprenorphine, Oxycodone, Morphine sulfate
- Where
- 3 sites in United States
- Volunteers
- 39 people
- Sponsor
- BioDelivery Sciences International
Type 2 Diabetes Mellitus
A Study to Investigate Different Doses of 0382 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus.
A Phase 2 study with two cohorts of differing doses designed to evaluate the efficacy, safety and pharmacokinetics (PK) of MEDI0382 in patients with Type 2 Diabetes Mellitus (T2DM).
- Trial name
- NCT03244800
- Testing
- MEDI0382
- Where
- 5 sites in Germany
- Volunteers
- 65 people
- Sponsor
- MedImmune LLC
Waldenstrom's Macroglobulinemia
Phase 1/2 Dose Escalation Study in Patients With Relapsed or Refractory Waldenstrom's Macroglobulinemia
Recent reports have identified a specific oncogenic mutation L265P of the MYD88 gene in approximately 90% of the patients with Waldenström's macroglobulinemia.
- Trial name
- 8400-401 (NCT02092909)
- Testing
- IMO-8400
- Where
- 10 sites in United States
- Volunteers
- 31 people
- Sponsor
- Idera Pharmaceuticals, Inc.
Major Depressive Disorder
AZD7268 Safety and Tolerability Study
The purpose of this study is to prove the principle that treatment with AZD7268 reduces depressive symptoms in patients with Major Depressive Disorder (MDD) compared with placebo.
- Trial name
- NCT01020799
- Testing
- AZD7268, Escitalopram
- Where
- 17 sites in United States
- Volunteers
- 247 people
- Sponsor
- AstraZeneca
Liver Cirrhosis
Zibotentan and Dapagliflozin Combination, EvAluated in Liver Cirrhosis (ZEAL Study)
This is a two part Phase IIa/b multicentre, randomised, double-blind, placebo-controlled, parallel group dose-ranging study to assess the efficacy, safety, and tolerability of the combination of zibotentan and dapagliflozin, and…
- Trial name
- ZEAL (NCT05516498)
- Testing
- Part A: zibotentan (dose B) + dapagliflozin, Part B: zibotentan (dose A) + dapagliflozin
- Where
- 50 sites in United States, Australia and 13 more
- Volunteers
- 205 people
- Sponsor
- AstraZeneca
Vascular Diseases
Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Vascular Diseases in Chinese Patients
The purpose of this study is to determine if the contrast agent is effective and safe in the Magnetic Resonance Imaging (MRI) of vascular diseases in patients of Chinese origin.
- Trial name
- NCT00395733
- Testing
- Gadobutrol (Gadavist, Gadovist, BAY86-4875), Gadopentate dimeglumine (Magnevist, BAY86-4882)
- Where
- 3 sites in China
- Volunteers
- 83 people
- Sponsor
- Bayer
COVID 19
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALG-097558 in Subjects With Renal Impairment and in Healthy Subjects With Normal Renal Function
This is a Phase 1 non-randomized, open-label, multiple dose, parallel-group study of ALG-097558 in subjects with severe renal impairment and subjects without renal impairment, matched for age, body weight and, to the extent…
- Trial name
- NCT06698549
- Testing
- ALG-097558
- Where
- 3 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Aligos Therapeutics
Acute Lung Injury, Acute Respiratory Distress Syndrome
Safety, Tolerability and Preliminary Efficacy of FP-1201 in ALI and ARDS. Phase I/II
The purpose of this study was to assess the safety, tolerability and preliminary efficacy of FP-1201 (Interferon Beta) in patients with Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS).
- Trial name
- NCT00789685
- Testing
- Interferon Beta
- Where
- 8 sites in United Kingdom
- Volunteers
- 37 people
- Sponsor
- Faron Pharmaceuticals Ltd
Low Back Pain
Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Chronic Low Back Pain
The objective of this study is to determine the analgesic efficacy and safety of Buprenorphine Transdermal System (BTDS) 10 and 20 compared to placebo in opioid-naïve subjects with moderate to severe chronic low back pain.
- Trial name
- NCT00490919
- Testing
- Buprenorphine transdermal system
- Where
- 86 sites in United States
- Volunteers
- 539 people
- Sponsor
- Purdue Pharma LP
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