Clinical trials: Patient-Reported Outcomes
- Condition Patient-Reported Outcomes
- Funder type Industry (pharma, biotech, devices)
- Has posted results yes
Excessive Sleepiness
Efficacy and Tolerability of Armodafinil in Adults With Excessive Sleepiness Associated With Shift Work Disorder
The primary objective of the study is to determine whether armodafinil treatment is more effective than placebo treatment in patients with excessive sleepiness associated with shift work disorder (SWD) by measuring improved…
- Trial name
- NCT01080807
- Testing
- Armodafinil
- Where
- 63 sites in United States
- Volunteers
- 385 people
- Sponsor
- Cephalon
Obstructive Sleep Apnea
DeVilbiss AutoAdjust With SmartFlex Comparative Study
There will be equivalent therapeutic effectiveness between SmartFlex and standard modes when using the DeVilbiss AutoAdjust device.
- Trial name
- NCT01203956
- Testing
- SmartFlex, Standard
- Where
- 2 sites in United States
- Volunteers
- 28 people
- Sponsor
- DeVilbiss Healthcare LLC
Hearing Loss
Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System
The aim of this clinical investigation is to collect data on objective and subjective hearing performance, quality of life and safety in adult subjects with conductive hearing loss, mixed hearing loss or single-sided…
- Trial name
- NCT04041700
- Testing
- Osia 2 system
- Where
- 3 sites in Australia, Hong Kong
- Volunteers
- 29 people
- Sponsor
- Cochlear
Autoimmune Disease
Gastrointestinal and Health-related Quality of Life Outcomes in Patients With Autoimmune Diseases Treated With Mycophenolate
Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in gastrointestinal (GI) complications in some patients.
- Trial name
- NCT00351377
- Testing
- Enteric-coated Mycophenolate Sodium
- Where
- Germany
- Volunteers
- 111 people
- Sponsor
- Novartis Pharmaceuticals
Idiopathic Pulmonary Fibrosis
Patient-reported Monitoring of Symptoms and Spirometry Via the patientMpower Platform in Idiopathic Pulmonary Fibrosis
Pilot-scale, open-label, fixed-order, two-period crossover study in idiopathic pulmonary fibrosis (IPF) over 16 weeks. Patients will use an electronic health journal (patientMpower platform) to record treatment compliance, forced…
- Trial name
- NCT03104322
- Testing
- patientMpower platform, usual care
- Where
- Ireland
- Volunteers
- 7 people
- Sponsor
- patientMpower Ltd.
Restless Legs Syndrome
Polysomnography Study Of Pregabalin And Pramipexole Versus Placebo In Patients With Restless Legs Syndrome And Associated Sleep Disturbance
The purpose of this study is to assess the efficacy and safety of pregabalin and pramipexole versus placebo in the treatment of restless legs syndrome and associated sleep disturbance.
- Trial name
- NCT00991276
- Testing
- pregabalin, pramipexole
- Where
- 41 sites in United States
- Volunteers
- 85 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Plaque Psoriasis
A Study to Assess Treatment Satisfaction, Patient-reported Outcomes, Effectiveness, and Safety of a Fixed-dose Combination of Calcipotriene/Betamethasone Dipropionate PAD Cream in the Treatment of Mild-to-moderate Plaque Psoriasis of the Scalp in Adults
The main aim of this study is to assess treatment satisfaction, quality of life, treatment preference, adherence and convenience, psychosocial effects of scalp psoriasis, sleep quality, and effectiveness, and safety of…
- Trial name
- PRO-SCALP (NCT05811234)
- Testing
- CAL/BDP PAD Cream
- Where
- 37 sites in Germany, Spain and 1 more
- Volunteers
- 291 people
- Sponsor
- Almirall, S.A.
Acromegaly
Comparison of Oral Octreotide Capsules to Injectable Somatostatin Analogs in Acromegaly
Octreotide capsule is a novel, orally-administered formulation of the commercially-available injectable drug octreotide. In a recent phase 3 trial (OPTMAL; NCT03252353), oral octreotide capsules demonstrated sustained biochemical…
- Trial name
- MPOWERED (NCT02685709)
- Testing
- Octreotide capsules
- Where
- 53 sites in United States, Austria and 11 more
- Volunteers
- 146 people
- Sponsor
- Chiasma, Inc.
Stenosis, Spondylosis
Efficacy and Safety of Integra Accell Evo3 DBM in Instrumented Lumbar Spine Fusion
The objective of this study is to prospectively evaluate the performance of Integra Accell Evo3 Demineralized Bone Matrix as an adjunct for instrumented lumbar spine fusion with a retrospective comparison to a historical patient…
- Conditions
- Stenosis, Spondylosis, Degenerative Changes
- Trial name
- NCT01714804
- Testing
- Accell Evo3 Prospective Use
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- SeaSpine, Inc.
Multiple Myeloma
A Study to Investigate the Efficacy and Safety of Two Doses of GSK2857916 in Participants With Multiple Myeloma Who Have Failed Prior Treatment With an Anti-CD38 Antibody
Multiple myeloma (MM) is an incurable malignancy and accounts for 1 percentage (%) of all cancers and for 10% of all hematologic malignancies.
- Trial name
- NCT03525678
- Testing
- Belantamab mafodotin frozen liquid, Belantamab mafodotin lyophilized powder
- Where
- 59 sites in United States, Australia and 6 more
- Volunteers
- 221 people
- Sponsor
- GlaxoSmithKline
Ulcerative Colitis
Generate Real World Data On Tofacitinib Induction Therapy and Changes In Clinical and Patient Reported Outcomes.
This study is expected to contribute to the body of real-world data of tofacitinib's safety and efficacy profile in ulcerative colitis.
- Trial name
- KIC-START (NCT05069259)
- Testing
- Stool sample collection
- Where
- 5 sites in Switzerland
- Volunteers
- 18 people
- Sponsor
- Pfizer
Diabetes, Diabetes Mellitus, Type 2
A Trial Comparing the Efficacy, Patient-reported Outcomes and Safety of Insulin Degludec 200 U/mL vs Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Requiring High-dose Insulin
This trial is conducted in the United States of America (USA). The aim of the trial is to confirm the efficacy of IDeg (insulin degludec) versus IGlar (insulin glargine) in controlling glycaemia.
- Trial name
- NCT01570751
- Testing
- insulin degludec, insulin glargine
- Where
- 46 sites in United States, Puerto Rico
- Volunteers
- 145 people
- Sponsor
- Novo Nordisk A/S
Pain
EXPAREL Administered by Infiltration Into the TAP for Prolonged Postsurgical Analgesia in Lower Abdominal Surgeries
The purpose of this prospective, blinded assessor, randomized trial is to assess opioid use and patient-reported outcomes of EXPAREL as a foundation in postsurgical pain therapy in Transversus Abdominis Plane (TAP) infiltration…
- Trial name
- TRANSCEND (NCT01919190)
- Testing
- EXPAREL
- Where
- 13 sites in United States
- Volunteers
- 67 people
- Sponsor
- Pacira Pharmaceuticals, Inc
GERD, Acid Reflux Disease
Validation of Patient-reported Outcomes Measures for the Assessment of Gastroesophageal Reflux Disease (GERD) Symptoms
This research study is being done to gather information about how to do further clinical studies using AZD3355 as an add-on treatment to proton pump inhibitors (PPI).
- Conditions
- GERD, Acid Reflux Disease, Heartburn, Regurgitation
- Trial name
- C27 (NCT00703534)
- Testing
- AZD3355, Gelusil®
- Where
- 84 sites in United States
- Volunteers
- 478 people
- Sponsor
- AstraZeneca
Mycobacterium Infections, Nontuberculous
Validation of Patient Reported Outcome Measures in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex
The primary objective of this study is to generate evidence demonstrating the domain specification (via modern psychometric methods), reliability, validity, and responsiveness (within-subject meaningful change) of the…
- Trial name
- ARISE (NCT04677543)
- Testing
- ALIS, Azithromycin, Ethambutol
- Where
- 62 sites in United States, Argentina and 10 more
- Volunteers
- 99 people
- Sponsor
- Insmed Incorporated
Excessive Daytime Sleepiness, Narcolepsy
Study to Assess Patient Reported Outcomes With Armodafinil Treatment for Excessive Sleepiness in Adults With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome
The purpose of this study is to assess patient reported outcomes with armodafinil treatment in terms of improvement in sleepiness, satisfaction with treatment, impact on ability to engage in life activities (ie, daily or work and…
- Conditions
- Excessive Daytime Sleepiness, Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS)
- Trial name
- NCT00228566
- Testing
- Armodafinil
- Where
- 43 sites in United States
- Volunteers
- 247 people
- Sponsor
- Cephalon
Chronic Hepatitis C
Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in Canada
The interferon-free combination regimen of ombitasvir/paritaprevir/ritonavir/ with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC) has been shown to be safe and effective in…
- Trial name
- AMBER (NCT02581189)
- Testing
- Ombitasvir/paritaprevir/ritonavir, Dasabuvir, Ribavirin
- Volunteers
- 565 people
- Sponsor
- AbbVie
Knee Osteoarthritis
Patient-Reported and Radiographic Outcomes in Evaluating Lorecivivint (SM04690) for the Treatment of Knee Osteoarthritis
This phase 3 study is a multicenter, randomized, double-blind, placebo-controlled study of lorecivivint injected intra-articularly (IA) into the target knee (most painful) joint of moderately to severely symptomatic…
- Trial name
- STRIDES-Xray (NCT03928184)
- Testing
- Lorecivivint
- Where
- 99 sites in United States
- Volunteers
- 501 people
- Sponsor
- Biosplice Therapeutics, Inc.
Pulmonary Disease, Chronic Obstructive
A Study to Investigate the Association of Real-world Sensor-derived Biometric Data With Clinical Parameters and Patient-reported Outcomes for Monitoring Disease Activity in Patients With COPD
The purpose of this multicenter, prospective cohort study is to investigate the correlation of real-world sensor-derived biometric data obtained via a wearable device with clinical parameters and patient-reported outcomes (PROs)…
- Trial name
- NCT05655832
- Testing
- Vivalink wearable device
- Where
- 11 sites in Germany
- Volunteers
- 77 people
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Pancreas Transplantation, Kidney Transplantation
Gastrointestinal and Health-related Quality of Life Outcomes in Patients With Simultaneous Pancreas-Kidney Transplants
Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in gastrointestinal (GI) complications in some patients.
- Trial name
- NCT00267150
- Testing
- Enteric-coated mycophenolate sodium (EC-MPS)
- Where
- Germany
- Volunteers
- 31 people
- Sponsor
- Novartis Pharmaceuticals