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The purpose of this study is to determine whether treatment with Growth Hormone results in symptomatic improvement in patients with gastroparesis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | Patients with Gastroparesis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Growth Hormone | Drug | Subjects will receive somapacitan-beco (Sogroya®) administered as a subcutaneous injection once weekly for 12 weeks. All participants will receive a fixed dose of 1.5 mg weekly, regardless of sex. |
| Measure | Description | Time Frame |
|---|---|---|
| Gastroparesis Cardinal Symptom Index (GCSI) | The Gastroparesis Cardinal Symptom Index (GCSI) is a questionnaire that assesses the severity of gastroparesis symptoms of: nausea, early satiety, postprandial fullness, and upper abdominal pain. Scores range from 0-none to 4-very severe. | Baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Spontaneous Bowel Movements (CSBMs) | Number of bowel movements, without the aid of laxatives, after which the patient has the sensation of complete defecation. | Baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks |
| Gastrointestinal Patient Reported Outcomes Measurement Information System (GI- PROMIS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guillermo GI Program Coordinator, Research | Contact | 480-301-4679 | barahona.guillermo@mayo.edu | |
| Tisha Lunsford, MD | Contact | 480-301-6990 | lunsford.tisha@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Tisha Lunsford | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Recruiting | Phoenix | Arizona | 85054 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D018589 | Gastroparesis |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
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| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| C000718308 | somapacitan |
| ID | Term |
|---|---|
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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|
The Gastrointestinal Patient Reported Outcomes Measurement Information System (GI-PROMIS) scale assess 8 domains: gastroesophageal reflux, disrupted swallowing, diarrhea, bowel incontinence/soilage, nausea and vomiting, constipation, belly pain, and gas/bloat/flatulence. Scores are scaled so that an average healthy person would score 50 points. A higher score indicates worse gastrointestinal symptoms. |
| Baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks |
| Mayo Clinic in Arizona | Recruiting | Scottsdale | Arizona | 85259 | United States |
|
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |