Expired Study
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Omaha, Nebraska 68198


Purpose:

Treatment for 3.5-8 weeks with GH (0.05 mg/kg/day) +GLN+Diet, followed by continued compliance to the individualized oral diet and enteral GLN, will result in reduced volume of TPN infusion/week and/or reduced frequency of TPN infusions/week.


Criteria:

Inclusion Criteria: - Be male or female between 19 and 78 years of age, inclusive - Have a diagnosis of SBS and 1 or more of the following characteristics: - Dependent upon TPN and/or IV fluids - Unable to receive TPN because of a documented history of complications associated with the long-term parenteral infusions (e.g. lack of venous access, multiple septic events, progressive liver dysfunction while on TPN, etc) - A documented remnant bowel anatomy that is inconsistent with adequately supporting life without parenteral support (e.g. < 70 cm of healthy small intestine and a portion of colon, or less than 150 cm in patients with no colon) - A documented history of diarrhea and/or malabsorption that has significantly compromised the patient's nutritional and hydration status (e.g. significant weight loss - 5% over 1 month or 10% over 6 months, or a serum albumin < 3.5 g/dl, documented nutrient deficiencies, documented episodes of dehydration, etc). - Is able to eat at least some (>500 calories) of solid food on a regular basis or tolerate at least some (>500 calories) of an enteral feeding formula - Have stable liver and renal function - For patients with known hypertension and other cardiovascular disorders, be both compensated and stabilized on a regular therapeutic regimen - For women participating in the study, manifest or give assent to 1 of the following criteria to ensure that the patient does not become pregnant during the study: - The patient must be surgically sterile or demonstrably postmenopausal. - Any patient capable of becoming pregnant must have a negative urine pregnancy test and must agree to practice a method of contraception documented to have at least 90% reliability throughout the treatment period. - Have the ability to understand the requirements of the study, to provide written Informed Consent, and to abide by the study restrictions and agree to complete the required assessments in the Follow-up Period Exclusion Criteria: - Be pregnant or lactating - Have a history of mental deficiency or illness that might compromise compliance with the requirements of the study - Have clinically serious neurological dysfunction - Have hypoxemic pulmonary diseases (i.e., resting pAO2 < 75 torr) - Have unstable ischemic heart disease or uncompensated cardiac failure - Have participated in any study involving an investigations drug within 30 days prior to entry into this trial.


Study is Available At:


Original ID:

061-03


NCT ID:

NCT00742157


Secondary ID:


Study Acronym:


Brief Title:

Evaluate the Efficacy and Safety Growth Hormone, Glutamine and Diet in Patients With Short Bowel Syndrome (SBS)


Official Title:

An Open-label Evaluation of the Long-term Efficacy and Safety of a Standardized Regimen of Growth Hormone, Glutamine and a Modified Diet in the Treatment of Patients With Short Bowel Syndrome


Overall Status:

Terminated


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

19 Years


Maximum Age:

78 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Nebraska


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:

Lack of Enrollment


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

30


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Fedja Rochling, MB ChB
Principal Investigator
University of Nebraska

Study Dates

Start Date:March 2003
Completion Date:October 2008
Completion Type:Actual
Primary Completion Date:October 2008
Primary Completion Type:Actual
Verification Date:August 2011
Last Changed Date:August 15, 2011
First Received Date:August 26, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Utilize pooled data from previously studied patients (high-dose GH) and current patients (lower dose GH). Compare changes in nutritional status, hydration status and kidney function, liver function and physical functioning capacity in patients with SBS
Time Frame:6 months
Safety Issues:True
Outcome Type:Primary Outcome
Measure:Evaluate the change in volume and frequency of TPN infusions at 6 months compared to baseline following 3.5 - 8 weeks of treatment with GH+GLN+Diet, followed by the individualized oral diet and enteral GLN over a 6-month period.
Time Frame:6 months
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Growth Hormone
Description:dosage = 0.05mg/kg/day, in diluent for injection, once a day, for 23 - 54 days.
Arm Name:UNMC Group
Other Name:Humatrope = Somatropin (rDNA origin) for injection

Study Arms

Study Arm Type:No Intervention
Arm Name:UNMC Group
Description:Compare the low and high dose effects of Growth Hormone from previously pooled patients (high dose) and UNMC patients (low dose).

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Nebraska
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Eli Lilly and Company

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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