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NCT ID: NCT03297294 Terminated - Clinical trials for Painful Diabetic Neuropathy

Safety and Efficacy of EMA401 in Patients With Painful Diabetic Neuropathy (PDN)

EMPADINE
Start date: March 14, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate safety and efficacy of EMA401 compared to placebo in patients with painful diabetic neuropathy (PDN).

NCT ID: NCT03296163 Completed - Clinical trials for Non-small Cell Lung Cancer

A Study Comparing MB02 and Avastin® in Subjects With Stage IIIB/IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

STELLA
Start date: February 6, 2018
Phase: Phase 3
Study type: Interventional

This is a multicenter, multinational, double-blind, 1:1 randomized, parallel-group, equivalence Phase 3 study to compare the efficacy and safety of MB02 plus chemotherapy (carboplatin and paclitaxel) versus Avastin® plus chemotherapy (carboplatin and paclitaxel) in subjects with Stage IIIB/IV non-squamous NSCLC

NCT ID: NCT03290781 Completed - Ulcerative Colitis Clinical Trials

An Efficacy and Safety Study of Ontamalimab as Maintenance Therapy in Participants With Moderate to Severe Ulcerative Colitis

FIGARO UC 303
Start date: April 4, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of ontamalimab as maintenance therapy treatment of remission, based on composite score of patient-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis (UC).

NCT ID: NCT03290131 Completed - Multiple Sclerosis Clinical Trials

A Study to Investigate the Safety and Effectiveness of Arbaclofen Extended-Release Tablets for Patients With MS

OS440-3004
Start date: January 28, 2018
Phase: Phase 3
Study type: Interventional

Multiple Sclerosis (MS) is an acquired inflammatory demyelinating disease of the central nervous system (CNS) that is regarded as the foremost cause of non-traumatic neurologic disability in adults in North America. Spasticity is a common complication in MS and occurs in up to 84% of patients. The main sign of spasticity is resistance to passive limb movement characterized by increased resistance to stretching, clonus, and exaggerated deep reflexes. Osmotica Pharmaceutical is currently developing arbaclofen extended-release tablets (AERT) for the treatment of spasticity in patients with MS.

NCT ID: NCT03287869 Completed - Bipolar I Disorder Clinical Trials

A Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Participants With Bipolar I Disorder.

Start date: October 24, 2017
Phase: Phase 3
Study type: Interventional

This study evaluated the safety and evaluate the safety and tolerability of open-label brexpiprazole (2 - 4 mg/day, with a starting dose of 2 mg/day) for the treatment of adult subjects with bipolar I disorder. All participants received a starting dose of brexpiprazole.

NCT ID: NCT03286842 Completed - Clinical trials for HER2-ve Metastatic Breast Cancer

To Study Clinical Effectiveness and Safety of Olaparib Monotherapy in Metastatic Breast Cancer Patients.

Start date: January 17, 2018
Phase: Phase 3
Study type: Interventional

This open-label, multi-centre phase IIIb study will assess the effectiveness, benefits and potential harms in the use of olaparib monotherapy treatment for patients with HER2-ve metastatic breast cancer associated with germline or somatic breast cancer susceptibility gene (gBRCA1/2 or sBRCA1/2) mutations.

NCT ID: NCT03285594 Completed - Clinical trials for Type 2 Diabetes Mellitus

Efficacy and Safety of Sotagliflozin Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking Insulin Alone or With Other Oral Antidiabetic Agents

SOTA-INS
Start date: September 15, 2017
Phase: Phase 3
Study type: Interventional

Primary Objective: To demonstrate the superiority of sotagliflozin 400 milligrams (mg) versus placebo with respect to hemoglobin A1C (HbA1c) reduction in participants with type 2 diabetes mellitus (T2D) who have inadequate glycemic control on basal insulin alone or with oral antidiabetes drugs (OADs). Secondary Objectives: - To assess the effects of sotagliflozin 400 mg versus placebo on fasting plasma glucose (FPG), body weight, systolic blood pressure (SBP), and HbA1c. - To assess the effects of sotagliflozin 200 mg versus placebo on HbA1c, body weight, FPG, and SBP. - To evaluate the safety of sotagliflozin 400 and 200 mg versus placebo.

NCT ID: NCT03285308 Terminated - Diabetes Mellitus Clinical Trials

A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis 01

Start date: September 29, 2017
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety and efficacy of relamorelin compared to placebo in participants with diabetic gastroparesis. Participants will report daily severity scores of their diabetic gastroparesis symptoms.

NCT ID: NCT03283085 Completed - Ulcerative Colitis Clinical Trials

A Safety Extension Study of Ontamalimab in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)

Start date: February 27, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of long-term treatment with ontamalimab in participants with moderate to severe Ulcerative Colitis (UC) or Crohn's disease (CD)

NCT ID: NCT03277690 Completed - Clinical trials for Endogenous Cushing's Syndrome

A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing's Syndrome.

Start date: September 26, 2017
Phase: Phase 3
Study type: Interventional

This is a double-blind, randomized, placebo-controlled withdrawal and rescue/restoration study in subjects with endogenous Cushing's Syndrome (CS) previously treated with single-arm, open-label levoketoconazole that will assess efficacy, safety, tolerability, and pharmacokinetics of levoketoconazole.