Safety and Efficacy of IV Infusion of Investigational Agent (TZP-101) in Patients With Diabetic Gastroparesis

NCT00639808 | Completed Phase 1

• 2 other identifiers: TZP-101-CL-002EudraCT 2006-002730-38
• Study Type: interventional
• Target: 10
• Locations: 2 countries
• Sites: 3

Brief Summary

The purpose of this study is to determine whether TZP-101 is safe in people with diabetes. Also to determine if TZP-101 is effective in increasing the gastric emptying rate in diabetic patients.

Conditions

Gastroparesis; Diabetes Mellitus

Keywords

delayed gastric emptying; symptomatic gastroparesis; diabetes mellitus

Outcome Measures

Primary Outcomes (1)

• 12-lead ECG data

  8 assessments including baseline (prior to start of infusion of study drug) until 24 four hours after start of infusion.

Secondary Outcomes (1)

• Scintigraphy to measure rate of gastric emptying after ingestion of a radio-labeled meal

  Measurements at: 30, 60, 120, 180, 210, and 240 minutes after the meal is eaten

Study Arms (2)

1

PLACEBO COMPARATOR

Drug: 5% dextrose in water

2

EXPERIMENTAL

TZP-101

Drug: TZP-101

Interventions

5% dextrose in water DRUG

60 ml IV infusion over 30 minutes

Also known as: D5W

1

TZP-101 DRUG

1 infusion: IV 2ml/min for 30 minutes for 1 day of either 160, 320 or 600 micrograms/kg

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has type 1 or type 2 diabetes mellitus
• Subject has documented diagnosis of gastroparesis by:
• Delayed gastric emptying (gastric retention ≥60% at 2h and ≥10% at 4 h; based on scintigraphy -4h standardized radionuclide solid meal)
• A minimum 3 month history of chronic upper abdominal discomfort (two or more: chronic postprandial fullness, bloating, epigastric discomfort, early satiety, belching after meal, postprandial nausea, vomiting)
• Subject has normal upper endoscopy
• If female, must be permanently sterilized or postmenopausa.

You may not qualify if:

• Patient has received any investigational drug within the preceding 30 days
• Patient is taking unstable doses of medication that affects gastric motility
• Patient has co-morbid condition
• Patient has a positive laboratory test result for hepatitis B, hepatitis C, HIV, or controlled substances.
• Patient has a history of a psychiatric disorder (including drug or alcohol addiction) requiring care by a psychiatrist or psychologist within the preceding 12 months.
• Patient has a recent,adult history of clinically significanthypersensitivity reaction(s) to any drug.
• Patient has known history of alcoholism

Sponsors & Collaborators

• Tranzyme, Inc.: lead

Study Sites (3)

Aarhus Hospital

Aarhus, Denmark

Location

Hvidore Hospital

Copenhagen, Denmark

Location

Karolinska University Hospital

Stockholm, Sweden

Location

MeSH Terms

Conditions

Gastroparesis; Diabetes Mellitus

Interventions

Glucose; Water; ulimorelin

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 13, 2008
• First Posted: March 20, 2008
• Study Start: August 1, 2006
• Primary Completion: July 1, 2007
• Study Completion: March 1, 2008
• Last Updated: March 20, 2008

Record last verified: 2008-03

Locations

DK (2); SE (1)