Functional Dyspepsia Clinical Trial
Official title:
Efficacy and Safety of Linaclotide in Patients With Overlap of Functional Dyspepsia and Constipation-predominant Irritable Bowel Syndrome
This study aims to assess the efficacy and safety of linaclotide in patients with overlapping symptoms of both functional dyspepsia (FD) and constipation-predominant irritable bowel syndrome (IBS-C).
Status | Recruiting |
Enrollment | 78 |
Est. completion date | February 2022 |
Est. primary completion date | December 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. Outpatients 2. Diagnosis of FD (including postprandial distress syndrome [PDS] with or without epigastric pain syndrome [EPS]) (Rome ? criteria) 3. Diagnosis of IBS-C (Rome ? criteria) Exclusion Criteria: 1. Helicobacter Pylori infection 2. GI symptoms caused by taking non-steroidal anti-inflammatory drugs or other agents 3. Pregnancy |
Country | Name | City | State |
---|---|---|---|
China | RenJiH | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
RenJi Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Treatment satisfaction assessed by the VAS | Treatment satisfaction will be assessed by the Visual Analogue Scale: score 0=not at all, 1=partial relief of general GI symptoms, 2=complete relief of general GI symptoms. | Week 4 | |
Secondary | Changes in stool frequency | Stool frequency will be assessed using bowel movement (BM), spontaneous bowel movement (SBM), complete spontaneous bowel movement (CSBM) during the past 7 days.
Change = (Week 4 Score - Baseline Score). |
Baseline and Week 4 | |
Secondary | Changes in stool consistency | Stool consistency will be assessed using Bristol Stool Form Scale (BSFS), which contains 7 types of stool consistency.
Change = (Week 4 Score - Baseline Score). |
Baseline and Week 4 | |
Secondary | Changes in defecation straining score | Defecation straining score will be assessed using six-point scale (score 0 = effortless, 5 = extremely laborious).
Change = (Week 4 Score - Baseline Score). |
Baseline and Week 4 | |
Secondary | Changes in defecation time | Defecation time will be assessed using approximate duration: less than 15 minutes, 15-30 minutes, more than 30 minutes. | Baseline and Week 4 | |
Secondary | Changes in sensation of complete evacuation | Sensation of complete evacuation will be assessed using five-point scale (score 0 = not at all, 4 = complete totally).
Change = (Week 4 Score - Baseline Score). |
Baseline and Week 4 | |
Secondary | Changes in lower abdominal discomfort | Lower abdominal discomfort will be assessed using six-point scale (score 0 = not at all, 5 = extremely severe).
Change = (Week 4 Score - Baseline Score). |
Baseline and Week 4 | |
Secondary | Changes in lower abdominal pain | Lower abdominal pain will be assessed using six-point scale (score 0 = not at all, 5 = extremely severe).
Change = (Week 4 Score - Baseline Score). |
Baseline and Week 4 | |
Secondary | Changes in FD symptoms | FD symptoms will be assessed using Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM).
Change = (Week 4 Score - Baseline Score). |
Baseline and Week 4 | |
Secondary | Changes in the anxiety status | The anxiety status will be assessed using the Generalized Anxiety Disorder scale (GAD-7).
Change = (Week 4 Score - Baseline Score). |
Baseline and Week 4 | |
Secondary | Changes in the depression status | The depression status will be assessed using the Patient Health Questionnaire (PHD-9).
Change = (Week 4 Score - Baseline Score). |
Baseline and Week 4 |
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