Clinical trials: Withdrawal
Psoriasis
Secukinumab Study in PSOriasis Exploring pruRITUS Intensity and Lesional Biomarkers
The study is designed to explore the kinetics of psoriasis symptoms, pruritus intensity and lesional biomarkers.
- Trial name
- PSORITUS (NCT02362789)
- Testing
- Secukinumab
- Where
- 19 sites in Germany
- Volunteers
- 132 people
- Sponsor
- Novartis Pharmaceuticals
Irritable Bowel Syndrome Characterized by Constipation
A Trial of Linaclotide 290 μg in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
To evaluate the efficacy on abdominal symptoms (abdominal bloating, abdominal discomfort, and abdominal pain) and safety of linaclotide 290 μg administered orally to patients with IBS-C.
- Trial name
- NCT03573908
- Testing
- Linaclotide
- Where
- 79 sites in United States
- Volunteers
- 614 people
- Sponsor
- Ironwood Pharmaceuticals, Inc.
Neonatal Opiate Withdrawal Syndrome
Eating, Sleeping, Consoling for Neonatal Withdrawal (ESC-NOW): a Function-Based Assessment and Management Approach
The overall objective is to determine if the ESC care approach will reduce the time until infants being managed for NOWS are medically ready for discharge.
- Trial name
- (ESC-NOW) (NCT04057820)
- Testing
- Finnegan Neonatal Abstinence Scoring Tool, Eat, Sleep, Console (ESC) care tool
- Where
- 26 sites in United States
- Volunteers
- 1,305 people
- Sponsor
- Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program
Kidney Diseases
Steroid Withdrawal in Pediatric Renal Transplant: Impact on Growth, Bone Metabolism and Acute Rejection
The present study investigates the safety and efficacy of steroid withdrawal at six days post-transplant in pediatric renal recipients under concomitant immunosuppression based on antibodies anti IL2 (interleukin 2), Tacrolimus…
- Trial name
- NCT00707759
- Testing
- Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + Withdrawal Prednisone, Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone
- Where
- Chile
- Volunteers
- 28 people
- Sponsor
- Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
Hypertension
A Study on the Long-term Efficacy of Nebivolol After Withdrawal of Therapy
This study will evaluate the long-term efficacy of nebivolol monotherapy in patients with stage 1 or stage 2 hypertension after the withdrawal of active medication.
- Trial name
- NCT00785512
- Testing
- Nebivolol
- Where
- 26 sites in United States
- Volunteers
- 207 people
- Sponsor
- Forest Laboratories
Nicotine Dependence
Nicotine Replacement Therapy (NRT) and Bupropion Mechanisms of Effectiveness in Smokers
The purpose of this study is to better characterize differences in mood, attention, brain activation patterns underlying the beneficial effects of pharmacological treatments previously demonstrated to be help individuals…
- Trial name
- NCT01048944
- Testing
- Bupropion SR, Nicotine Patch
- Where
- United States
- Volunteers
- 197 people
- Sponsor
- Southern Illinois University Carbondale
Substance Withdrawal Syndrome
Effect of Ondansetron for Withdrawal Symptoms
We hope to determine whether Ondansetron, an anti-nausea medication, works to help relieve withdrawal symptoms experienced while the patient is being weaned off opioid medications.
- Trial name
- NCT00695864
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Stanford University
Schizophrenia
PEARL Schizophrenia Maintenance
Lurasidone HCI is a compound that is FDA-approved for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that Lurasidone is effective in the long term maintenance treatment of schizophrenia.
- Trial name
- NCT01435928
- Testing
- Lurasidone
- Where
- 75 sites in United States, France and 5 more
- Volunteers
- 676 people
- Sponsor
- Sumitomo Pharma America, Inc.
Tobacco Use Disorder
Low Nicotine Content Cigarettes in Vulnerable Populations: Opioid Use Disorder
Prevalence of smoking among individuals with opioid use disorder (OUD) is six-fold that of the general US adult population. The mortality rate of opioid-dependent smokers is four times that of opioid-dependent nonsmokers, and…
- Trial name
- NCT04092101
- Testing
- Cigarettes with varying nicotine content, E-Cigarettes
- Where
- 2 sites in United States
- Volunteers
- 326 people, healthy volunteers welcome
- Sponsor
- University of Vermont
Phenylketonuria
Efficacy and Safety of SYNB1934 in Patients With PKU (SYNPHENY-3)
SYNB1934-CP-003 was designed as a 3-part, adaptive study consisting of a dose-escalating, open-label period (DEP; Part 1) of up to 15 weeks, followed by a 4-week, double-blind, placebo-controlled, randomized withdrawal period…
- Trial name
- SYNPHENY-3 (NCT05764239)
- Testing
- SYNB1934v1
- Where
- 21 sites in United States, Canada and 2 more
- Volunteers
- 35 people
- Sponsor
- Synlogic
Systemic Lupus Erythematosus
Biomarkers of Lupus Disease: Serial Biomarker Sampling in Patients With Active Systemic Lupus Erythematosus (SLE)
Hypothesis: A reason for repeated disappointing outcomes of clinical trials testing targeted immune biologics for lupus may be the heterogeneity of the disease, exacerbated by the variable effects on immune homeostasis of the…
- Trial name
- BOLD (NCT00987831)
- Testing
- Group B SLE one blood donation, Blood drawing only Group C, Group A SLE prospective study
- Where
- 2 sites in United States
- Volunteers
- 158 people, healthy volunteers welcome
- Sponsor
- Oklahoma Medical Research Foundation
Hyponatremia
Study of the Safety and Effectiveness of SAMSCA® (Tolvaptan) in Children and Adolescents With Euvolemic or Hypervolemic Hyponatremia
The purpose of this trial was to demonstrate that tolvaptan effectively and safely increases and maintains serum sodium concentrations in children and adolescent participants with euvolemic or hypervolemic hyponatremia.
- Trial name
- NCT02012959
- Testing
- Tolvaptan
- Where
- 7 sites in United States, Italy and 1 more
- Volunteers
- 9 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Chronic Kidney Disease, Hyperphosphatemia
A Phase III, Multicentre, Double-Blind, Placebo-Controlled Withdrawal Study in Patients With Hyperphosphatemia
This is a phase III multi-centre study in three periods: the first period is a phosphate binder washout for 4 weeks, the second period is an open-label, randomised, parallel group, flexible dose, the third period is a…
- Trial name
- NCT00416520
- Testing
- MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®), Another phosphate binder (Sevelamer)
- Where
- 68 sites in Australia, Austria and 9 more
- Volunteers
- 336 people
- Sponsor
- Tanabe Pharma Corporation
Diabetes Mellitus, Type 1
Diabetes Autoimmunity Withdrawn In New Onset and In Established Patients
The study is a prospective, randomized, 52-week double-blind, placebo-controlled, multicenter trial in subjects with Type 1 diabetes (T1D) followed by a 2-year safety follow-up.
- Trial name
- SUNRISE (NCT03895437)
- Testing
- TOL-3021
- Where
- 23 sites in United States
- Volunteers
- 78 people
- Sponsor
- Tolerion, Inc.
Cystic Fibrosis
A Trial of Pulmozyme Withdrawal on Exercise Tolerance in Cystic Fibrosis Subjects With Severe Lung Disease (TOPIC)
This was a multicenter, randomized, double-blind, placebo-controlled study of patients with severe, though stable, cystic fibrosis (CF) whose routine treatment included Pulmozyme.
- Trial name
- NCT00434278
- Testing
- Dornase alfa
- Where
- 40 sites in United States
- Volunteers
- 27 people
- Sponsor
- Genentech, Inc.
Chronic Kidney Diseases
Efficacy and Safety of KBP-5074 in Uncontrolled Hypertension and Moderate or Severe Chronic Kidney Disease (CKD)
This Phase 3, randomized, Double-blind, placebo-controlled, 2-arm, parallel-group, multicenter study with randomized withdrawal will evaluate the efficacy, safety, and durability of KBP-5074 in adult participants who have stage…
- Trial name
- Clarion-CKD (NCT04968184)
- Testing
- KBP-5074
- Where
- 215 sites in United States, Australia and 20 more
- Volunteers
- 666 people
- Sponsor
- Novo Nordisk A/S
Opioid-use Disorder
Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment
This is an open-label pilot trial to evaluate the safety and tolerability of lofexidine in the management of opioid withdrawal symptoms while initiating outpatient treatment with naltrexone.
- Trial name
- NCT04056182
- Testing
- Lofexidine 0.18 MG
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- New York State Psychiatric Institute
Chronic Plaque Psoriasis, Moderate to Severe Chronic Plaque Psoriasis
A Study With a Initial Treatment Period Followed by a Randomized-withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Phase 3 study to compare the efficacy of bimekizumab versus placebo in the treatment of subjects with moderate to severe chronic plaque psoriasis.
- Conditions
- Chronic Plaque Psoriasis, Moderate to Severe Chronic Plaque Psoriasis, Psoriatic Arthritis
- Trial name
- BE READY (NCT03410992)
- Testing
- Bimekizumab
- Where
- 77 sites in United States, Australia and 7 more
- Volunteers
- 435 people
- Sponsor
- UCB Biopharma SRL
Alcohol Use Disorder
Non-invasive Vagal Nerve Stimulation in Alcohol Use Disorder
Alcohol use disorder (AUD) is a major health concern amongst Veterans as it causes poor health, lost days at work, impaired psychosocial functioning, and decreased quality of life.
- Trial name
- NCT05226130
- Testing
- Cervical transcutaneous vagus nerve stimulation (active comparator)
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- VA Office of Research and Development
Crohn's Disease
A follow-on Safety Study in Subjects With Crohn's Disease Who Have Previously Been Withdrawn From the Double-blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] Due to an Exacerbation of Crohn's Disease
A follow-on safety study in subjects with Crohn's Disease who have previously been withdrawn from the double-blind study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] due to an exacerbation of Crohn's Disease.
- Trial name
- PRECiSE 4 (NCT00160706)
- Testing
- Certolizumab Pegol (CDP870)
- Where
- 141 sites in United States, Australia and 22 more
- Volunteers
- 310 people
- Sponsor
- UCB Pharma SA