Affects of Once-daily Oral Administration of TZP-102 on the Treatment of Symptoms Associated With Diabetic Gastroparesis

NCT01452815 | Completed Phase 2

• 1 other identifier: TZP-102-CL-G003
• Study Type: interventional
• Target: 201
• Locations: 8 countries
• Sites: 52

Brief Summary

The purpose of this study is to test the safety and effectiveness of two dosage levels (10mg and 20mg) of TZP-102 compared to placebo (capsule that looks like the study drug but contains no active drug), administered once-daily for 12 weeks, in diabetic subjects with symptoms associated with gastroparesis.

Conditions

Gastroparesis; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Keywords

diabetic gastroparesis; delayed gastric emptying; gastroparesis; diabetes mellitus, Type 1; diabetes mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change from baseline in symptoms associated with diabetic gastroparesis

  12 Weeks

Secondary Outcomes (4)

• Change from baseline on health-related quality of life

  12 Weeks

• Adverse Events (AEs)

  12 Weeks

• Cardiovascular Parameters (blood pressure, heart rate, 12-Lead ECG)

  12 Weeks

• Clinical Chemistry and Hematology Parameters

  12 Weeks

Study Arms (3)

1

PLACEBO COMPARATOR

Drug: placebo

Drug: Placebo

2

EXPERIMENTAL

10mg TZP-102

Drug: 10mg TZP-102

3

EXPERIMENTAL

20mg TZP-102

Drug: 20mg TZP-102

Interventions

Placebo DRUG

Two #2 oval shaped,opaque-white, hard gelatin shell capsules containing inactive ingredients taken orally once daily for 12 weeks.

1

10mg TZP-102 DRUG

One 10mg #2 oval shaped, opaque-white, hard gelatin shell capsule containing active ingredients and one placebo capsule each taken orally once daily for 12 Weeks

2

20mg TZP-102 DRUG

Two 10mg #2 oval shaped, opaque-white, hard gelatin shell capsules containing active ingredients

3

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 80 years of age, inclusive
• Type 1 or type 2 diabetes mellitus
• History of symptoms of gastroparesis for at least 3 months leading up to the Screening Visit
• Gastric half-emptying time \>82 minutes, demonstrated by the Gastric Emptying Breath Test performed at the Screening Visit OR documented delayed gastric emptying within the previous 24 months
• Mild to moderate severity of gastroparesis symptoms during the screening period
• Body Mass Index (BMI) \< 45.0 at the Screening Visit
• Glycosylated hemoglobin (HbA1c) level \< 11.0% at the Screening Visit
• Upper gastrointestinal obstruction ruled out by endoscopy or barium scan
• Concomitant medications must be stable for at least 2 weeks leading up to the Baseline Visit and must be maintained during the study.
• Females of child-bearing potential must have a negative serum pregnancy test and use (and agree to continue to use throughout the study) an acceptable form of contraception.

You may not qualify if:

• Persistent daily vomiting
• Gastrectomy, bariatric surgery, fundoplication or vagotomy/pyloroplasty
• Has had or plans to have endoscopic pyloric injections of botulinum toxin within 6 months prior to the Screening Visit or during the study.
• NG, PEG or PEJ feeding tube within 2 weeks prior to the Screening Visit
• Required in-patient hospitalization for treatment of gastroparesis within 2 weeks prior to the Screening Visit
• Required parenteral nutrition for treatment of gastroparesis within 2 months prior to the Screening Visit
• Active gastric pacemaker within 3 months prior to the Screening Visit
• Participated in an investigational study within 30 days prior to the Screening Visit
• Chronic severe diarrhea
• Diabetic ketoacidosis that required inpatient hospitalization within 30 days prior to the Screening Visit
• History of any eating disorder within 2 years prior to the Screening Visit
• Chronic obstructive pulmonary disease (COPD) or chronic asthma
• Chronic smoker that is unable or unwilling to abstain from smoking during the two visits that the gastric emptying breath test will be performed
• History of risk factors for Torsades de Pointes
• Corrected QT interval calculated using Fredericia's formula \>= 500 msec, recorded and confirmed on any of the three ECG assessments performed during the screening period

Sponsors & Collaborators

• Tranzyme, Inc.: lead

Study Sites (52)

Tranzyme Investigational Site

Huntsville, Alabama, 35801, United States

Location

Tranzyme Investigational Site

Tucson, Arizona, 85710, United States

Location

Tranzyme Investigational Site

Jonesboro, Arkansas, 72401, United States

Location

Tranzyme Investigational Site

Little Rock, Arkansas, 72117, United States

Location

Tranzyme Investigational Site

Long Beach, California, 90822, United States

Location

Tranzyme Investigational Site

Stanford, California, 94305, United States

Location

Tranzyme Investigational Site

Ventura, California, 93003, United States

Location

Tranzyme Investigational Site

Hialeah, Florida, 33016, United States

Location

Tranzyme Investigational Site

Inverness, Florida, 34450, United States

Location

Tranzyme Investigational Site

Jacksonville, Florida, 32256, United States

Location

Tranzyme Investigational Site

Miami, Florida, 33144, United States

Location

Tranzyme Investigational Site

Miami, Florida, 33183, United States

Location

Tranzyme Investigational Site

New Smyrna Beach, Florida, 32168, United States

Location

Tranzyme Investigational Site

Port Orange, Florida, 32127, United States

Location

Tranzyme Investigational Site

Oak Lawn, Illinois, 60453, United States

Location

Tranzyme Investigational Site

Anderson, Indiana, 46016, United States

Location

Tranzyme Investigational Site

Kansas City, Kansas, 66160, United States

Location

Tranzyme Investigational Site

Monroe, Louisiana, 71201, United States

Location

Tranzyme Investigational Site

Boston, Massachusetts, 02215, United States

Location

Tranzyme Investigational Site

Mexico, Missouri, 65265, United States

Location

Tranzyme Investigational Site

Fayetteville, North Carolina, 28304, United States

Location

Tranzyme Investigational Site

Raleigh, North Carolina, 27612, United States

Location

Tranzyme Investigational Site

Salisbury, North Carolina, 28144, United States

Location

Tranzyme Investigational Site

Winston-Salem, North Carolina, 27103, United States

Location

Tranzyme Investigational Site

Oklahoma City, Oklahoma, 73104, United States

Location

Tranzyme Investigational Site

Portland, Oregon, 97210, United States

Location

Tranzyme Investigational Site

Philadelphia, Pennsylvania, 19140, United States

Location

Tranzyme Investigational Site

Jackson, Tennessee, 38305, United States

Location

Tranzyme Investigational Site

El Paso, Texas, 79905, United States

Location

Tranzyme Investigational Site

Houston, Texas, 77034, United States

Location

Tranzyme Investigational Site

Tacoma, Washington, 98405, United States

Location

Tranzyme Investigational Site

Bruges, 8310, Belgium

Location

Tranzyme Investigational Site

Brussels, 1200, Belgium

Location

Tranzyme Investigational Site

Ghent, B-9000, Belgium

Location

Tranzyme Investigational Site

Aarhus, 8000, Denmark

Location

Tranzyme Investigational Site

Gentofte Municipality, Denmark

Location

Tranzyme Investigational Site

Odense, 5000, Denmark

Location

Tranzyme Investigational Site

Porvoo, 06151, Finland

Location

Tranzyme Investigational Site

Tampere, Finland

Location

Tranzyme Investigational Site

Essen, 45136, Germany

Location

Tranzyme Investigational Site

Mainz, 55116, Germany

Location

Tranzyme Investigational Site

Stuttgart, 70191, Germany

Location

Tranzyme Investigational Site

Bergen, 5021, Norway

Location

Tranzyme Investigational Site

Bialystok, Poland

Location

Tranzyme Investigational Site

Bydgoszcz, 85-094, Poland

Location

Tranzyme Investigational Site

Kielce, 25-035, Poland

Location

Tranzyme Investigational Site

Krakow, Poland

Location

Tranzyme Investigational Site

Lodz, Poland

Location

Tranzyme Investigational Site

Olsztyn, Poland

Location

Tranzyme Investigational Site

Warsaw, 02-097, Poland

Location

Tranzyme Investigational Site

Stockholm, Sweden

Location

Tranzyme Investigational Site

Uppsala, Sweden

Location

Related Publications (1)

• McCallum RW, Lembo A, Esfandyari T, Bhandari BR, Ejskjaer N, Cosentino C, Helton N, Mondou E, Quinn J, Rousseau F; TZP-102 Phase 2b Study Group. Phase 2b, randomized, double-blind 12-week studies of TZP-102, a ghrelin receptor agonist for diabetic gastroparesis. Neurogastroenterol Motil. 2013 Nov;25(11):e705-17. doi: 10.1111/nmo.12184. Epub 2013 Jul 15.

  PMID: 23848826 DERIVED

MeSH Terms

Conditions

Gastroparesis; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Officials

• Connie Cosentino

  Tranzyme Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2011
• First Posted: October 17, 2011
• Study Start: September 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: April 25, 2013

Record last verified: 2012-08

Locations

FI (2); DE (3); PL (7); US (31); DK (3); NO (1); SE (2); BE (3)