Health TrialsbyHealthPanel

Growth Hormone for the Treatment of Gastroparesis

ConditionGastroparesis
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMayo Clinic

About this trial

The purpose of this study is to determine whether treatment with Growth Hormone results in symptomatic improvement in patients with gastroparesis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Symptoms > 6 months that have not responded satisfactorily to standard treatment.

For gastroparesis: Gastroparesis Cardinal Symptom Index (GCSI) score of >21

Disqualifiers

Known history of GH deficiency, hypothalamic or pituitary disease

Diabetes

Prior use of GH therapy

Age-adjusted low serum IGF1

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Treatment GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks

Secondary outcomes

1

Complete Spontaneous Bowel Movements (CSBMs)

Number of bowel movements, without the aid of laxatives, after which the patient has the sensation of complete defecation.

Time frame
Baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks
2

Gastrointestinal Patient Reported Outcomes Measurement Information System (GI- PROMIS)

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.

Time frame
Baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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