Sleep Disturbance Clinical Trial
Official title:
Clinical Trial: Esomeprazole Plus Alginate vs. Esomeprazole Alone for Treatment of Nighttime Reflux Symptom and GERD-related Sleep Disturbances in Patients With Erosive GERD
Among those patients experienced GERD symptoms, up to 89% report nocturnal symptoms, resulting in poor sleep quality. Sodium alginate oral suspension (Alginos) is a medication indicated for the relief of gastroesophageal reflux symptoms. This multi-center, open-label, randomized trial intends to compare the addition of one dose Alginos (50mg/ml, 20ml) at bed time (Nexium plus Alginos), with no additional alginate treatment (Nexium alone), in erosive GERD patients taking Nexium (40mg/tablet) daily for 4 weeks. Efficacy endpoints include percentage of patients with relief or complete resolution of nighttime heartburn (or regurgitation), percentage of patients with relief or complete resolution of GERD-related sleep disturbance, the percentage of nights without nighttime heartburn (or regurgitation) over treatment period, change from baseline of the Pittsburgh Sleep Quality Index (PSQI) questionnaire total score, and change of the percentage of patients with relief of nighttime heartburn (or regurgitation) at post-treatment visit as compared to final visit in test group (Nexium plus Alginos). Safety endpoint is incidence of adverse events. The study hypothesis is that sodium alginate plus esomeprazole is superior to esomeprazole alone in relieving nighttime reflux symptoms and sleep disturbance in erosive GERD patients.
Status | Recruiting |
Enrollment | 340 |
Est. completion date | June 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Out -patients with age of 20-80 years old (inclusive) in Taiwan of both genders - Patients who had been previously diagnosed as erosive GERD (i.e. grade A~D according to the modified Los-Angeles Classification. Endoscopic examination results within 21 days before randomization visit (V2) are acceptable. - Patients with history of heartburn (or regurgitation) for = 3 months before entering study - Patients with history of GERD-related sleep disturbances for = 1 month before entering study - Patients with nighttime heartburn (or regurgitation) graded as moderate, or severe, on = 3 nights in the last 7 days of screening period - Patients with GERD-related sleep disturbances on = 3 nights in the last 7 days of screening period - Patients with the global PSQI score >5 - Patients have signed the informed consent form Exclusion Criteria: - Patients with non-erosive GERD, Barrett's esophagus or esophageal stricture - Patients with any conditions other than GERD that could be the primary cause of sleep disturbance (e.g. sleep apnoea, obstructed airway, severe depression, severe anxiety, panic attacks, chronic obstructive pulmonary disease requiring oxygen therapy) - Patients with active esophageal, gastric or duodenal ulcers - Patients with history of esophageal, gastric or duodenal surgery - Patients with active cancers of any kind - Female patients who are pregnant or lactating - Patients who were allergy to any of the study drugs - Patients taken a proton pump inhibitor (PPI) within 7 days, or any prokinetic agent, H2-blocker, alginate preparations or antacid within 2 days before screening - Patients with a history of drug addiction or alcohol abuse within the past 12 months - Patients with any other conditions or diseases that investigator considers it is not appropriate to enter the study |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Taiwan | Chang Gung Memorial Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
Chang Gung Memorial Hospital | TTY Biopharm |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Incidence of adverse events | the 28 days treatment period | Yes | |
Primary | Percentage of patients with relief of nighttime heartburn (or acid regurgitation) | the last 7 days of study | No | |
Secondary | Percentage of patients with complete resolution of nighttime heartburn (or regurgitation) | the last 7 days of study | No | |
Secondary | Percentage of Patients with relief of GERD-related sleep disturbance | the last 7 days of study | No | |
Secondary | Percentage of Patients with complete resolution of GERD-related sleep disturbance | the last 7 days of study | No | |
Secondary | The percentage of nights without nighttime heartburn (or regurgitation) over treatment period | the 28 days treatment period | No | |
Secondary | Change from baseline of the Pittsburgh Sleep Quality Index questionnaire total score (global PSQI score) at the end of study | the 28 days treatment period | No | |
Secondary | Change of the percentage of patients with relief of nighttime heartburn (or acid regurgitation) at post-treatment visit (V4) as compared to final visit (V3) in test group (Nexium plus Alginos) | 28 days after treatment stop | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04959214 -
The Effect Of Progressıve Relaxatıon Exercıses
|
N/A | |
Recruiting |
NCT05820919 -
Enhancing Sleep Quality for Nursing Home Residents With Dementia - R33 Phase
|
N/A | |
Completed |
NCT05555186 -
The Effects of Bright Light Therapy on Adolescent's Sleep Quality and Well-being
|
N/A | |
Completed |
NCT05093465 -
A Comparison of Two Behavioral Sleep Interventions Among College Students (ProjectTECH)
|
N/A | |
Completed |
NCT03673397 -
The Acute Effect of Aerobic Exercise on Sleep in Patients With Depression
|
N/A | |
Recruiting |
NCT04368416 -
Anxiety/Depression, Sleep and Alcohol in Elderly Anxiety/Depression, Sleep Disturbances and Alcohol Use Disorder in Elderly With Cognitive Complaints
|
||
Completed |
NCT04566822 -
Calm Sleep Coaching
|
N/A | |
Not yet recruiting |
NCT06406309 -
Settling Down for Sleep in ADHD: The Impact of Sensory and Arousal Systems on Sleep in ADHD
|
N/A | |
Recruiting |
NCT00860756 -
Sleep Disturbance in Deployed Soldiers
|
Phase 0 | |
Recruiting |
NCT05699837 -
Alpha Entrainment for Pain and Sleep (Extension)
|
N/A | |
Completed |
NCT06108115 -
Smartphone-Based Intervention for Sleep Disturbance in Individuals Recovering From Alcohol Use Disorder
|
N/A | |
Completed |
NCT05511818 -
Radicle Rest: A Study of Cannabinoids on Sleep and Health Outcomes
|
N/A | |
Completed |
NCT04560595 -
Remote Guided Caffeine Reduction
|
N/A | |
Not yet recruiting |
NCT06104280 -
Medications for Opioid Use Disorder Photosensitive Retinal Ganglion Cell Function, Sleep, and Circadian Rhythms: Implications for Treatment
|
N/A | |
Enrolling by invitation |
NCT04290650 -
Sleep Disturbances in Patients With Psychotic Symptoms (AkuSleep)
|
N/A | |
Recruiting |
NCT04207502 -
Integrating Systematic Data of Geriatric Medicine to Explore the Solution for Health Aging
|
||
Suspended |
NCT03908905 -
Sleep Disturbances and Chronic Widespread Pain
|
||
Completed |
NCT03269760 -
Multimodal Sleep Pathway for Shoulder Arthroplasty
|
Phase 1 | |
Completed |
NCT04990206 -
Improving Sleep Health in Adults With Overweight or Obesity
|
N/A | |
Completed |
NCT03112824 -
Functional Assessment of Ashwagandaha Root Extract During Weight Loss
|
N/A |