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Trial · Interventional

RecruitingEarly phase 1Registry data

Growth Hormone for the Treatment of Gastroparesis

NCTNCT06803589 (opens ClinicalTrials.gov in a new tab)Other id24-003183
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Overview

Status
Recruiting
Phase
Early phase 1
Enrollment
10 participants (estimated)
Sponsor
Mayo Clinic · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
22 Oct 2024
Primary completion
Oct 2027 (estimated)
Completion
Dec 2027 (estimated)
First posted
31 Jan 2025
Last update posted
16 Apr 2026
Conditions
Gastroparesis

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20242025202620272028
  1. Ph Early 1

    Growth Hormone for the Treatment of Gastroparesis

    NCT06803589

    22 Oct 2024 to est. Dec 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • Growth HormoneDrug

Arms1

  • Experimental

    Treatment Group

    Patients with Gastroparesis

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Gastroparesis Cardinal Symptom Index (GCSI)

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

    Registry description

    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.

Secondary outcomes(2)

  1. Complete Spontaneous Bowel Movements (CSBMs)

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

    Registry description

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

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

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

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Symptoms \> 6 months that have not responded satisfactorily to standard treatment. * For gastroparesis: Gastroparesis Cardinal Symptom Index (GCSI) score of \>21 Exclusion Criteria: * Known history of GH deficiency, hypothalamic or pituitary disease * Diabetes * Prior use of GH therapy * Age-adjusted low serum IGF1 * Women on oral estrogen therapy6 * Pregnancy or nursing * History of malignant solid tumors * Obesity (BMI \> 30)History of coronary and thromboembolic diseases. * History of sarcoidosis * History of pituitary surgery * History of thyroid nodules. * Any other condition, which in the opinion of the investigator would impede compliance or hinder completion of the study. * Failure to give informed consent.

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