Nortriptyline for Idiopathic Gastroparesis - NCT00765895-79905 (Clinical Trial 344020)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy344020.aspx
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| City: |
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El Paso |
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State:
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TX |
| Zip Code: |
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79905 |
| Conditions: |
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Idiopathic Gastroparesis |
| Purpose: |
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The principal objective of this multicenter, randomized, placebo-controlled trial is to
evaluate whether treatment with nortriptyline will improve gastroparesis symptoms compared
with placebo.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- Age 25 through 65 years old at registration
- Documentation of delayed gastric emptying on gastric emptying scintigraphy within 2
years of registration, defined as greater than 60% retention at 2 hours or greater
than 10% retention at 4 hours
- Symptoms of gastroparesis for at least 6 months (does not have to be contiguous)
prior to registration with Gastroparesis Cardinal Symptom Index (GCSI) score of 21 or
greater
- Negative upper endoscopy or upper GI series within 2 years of registration
Exclusion Criteria:
- Normal gastric emptying confirmed with scintigraphy
- Diabetic gastroparesis or post-surgical gastroparesis including fundoplication
- Another active disorder which could explain symptoms in the opinion of the
investigator
- History of significant cardiac arrhythmias and/or prolonged QTc
- History of seizures
- Use of narcotics more than 3 days per week
- Use of tricyclic antidepressants for refractory symptoms of gastroparesis within 6
weeks prior to randomization
- Use of strongly anticholinergic medications
- Use of calcium channel blockers
- Use of erythromycin
- Clear history of failed trial of nortriptyline use for gastroparetic symptoms
- Symptoms of primary depression or suicidal ideation
- Contraindications to nortriptyline:
1. hypersensitivity or allergy to any tricyclic antidepressant drug
2. concomitant therapy with a monoamine oxidase inhibitor (MAOI)
3. recent myocardial infarction
4. glaucoma
- Contraindications to gastric emptying breath test such as a known allergy to egg,
wheat, or algae
- Pregnancy or nursing
- Any other condition, which in the opinion of the investigator would impede compliance
or hinder completion of the study
- Use of a G tube, J tube, central catheter, or gastric electrical stimulator
- Failure to give informed consent |
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| Study is available at: |
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Texas Tech University Health Sciences Center
El Paso, TX 79905
United States
Primary Contact:
Richard W McCallum, MD
Email: richard.mccallum@ttuhsc.edu
Phone: 915-545-6618
Secondary Contact:
James Tonascia, PhD
Email: jtonasci@jhsph.edu
Phone: 410-955-3704 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 16, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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