Clinical trial NCT01452815 (phase 2, status: completed)
Conditions: gastroparesis, diabetes mellitus, type 1, diabetes mellitus, type 2
ICD codes: K31.84, E10.65, E10.9, E10.21, E10.36, E10.41, E10.42, E10.44, E11.65, E11.9, E11.21, E11.36, E11.41, E11.42, E11.44
Drugs: placebo, 10mg tzp-102, 20mg tzp-102
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  18 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.

        Exclusion Criteria:

          -  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

          -  Bradycardia or hypotension assessed as clinically-significant by the investigator

          -  Requires treatment with concomitant medication that is a substrate of Cytochrome P450
             isoenzyme 3A4 and known to have a clinically recognized risk for Torsades de Pointes

          -  History of acute myocardial infarction, unstable angina or a transient (cerebral)
             ischemic attack within 12 months prior to the Screening Visit

          -  History of severe depression, psychiatric disorder or cognitive impairment

          -  History of alcohol or drug abuse or dependency within 2 years prior to the Screening
             Visit

          -  Taking opiates for abdominal pain

          -  Known history of Hepatitis B or C or HIV infection

          -  Requires dialysis or elevated creatinine at the Screening Visit

          -  Abnormal liver function tests at the Screening Visit

          -  Uncontrolled hypo- or hyperthyroidism

          -  Adrenal insufficiency

          -  Active malignancy other than basal cell or squamous cell carcinoma of the skin

          -  Pregnant or breast-feeding

          -  Allergies to components of the breath test meal or severe lactose intolerance

          -  Any other medical condition or social circumstance that, in the investigator's
             opinion, makes it inappropriate for the patient to participate in this clinical trial