Tricyclic Antidepressants (TCAs) on Gastric Emptying

NCT00220844 | Terminated

• 1 other identifier: TU4255
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effects of two tricyclic antidepressant agents (TCAs), amitriptyline and desipramine, on gastric emptying and gastric accommodation using a newly developed scintigraphic test that simultaneously measures both gastric emptying and gastric volume (accommodation). These two tricyclic antidepressant agents are commonly used at low doses to treat patients with refractory functional dyspepsia.

Conditions

Dyspepsia

Outcome Measures

Primary Outcomes (2)

• Gastric emptying

  4 hours

• Gastric volume

  30 minutes

Study Arms (2)

Nortriptyline

EXPERIMENTAL

Drug: Desipramine

Placebo

EXPERIMENTAL

Drug: Amitriptyline

Interventions

Desipramine DRUG

Nortriptyline

Amitriptyline DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sixty normal subjects, males and females within the ages of 18 to 65 years, will be studied. Normal control subjects will be recruited for voluntary participation through poster advertisements. A normal subject is defined as a person with no gastrointestinal (GI) symptoms; no prior history of peptic ulcer disease or irritable bowel disease; no previous history of a GI motility disorder (including, but not limited to, achalasia, gastroparesis); on no medications for GI disorders; no history of prior surgery on the GI tract (esophagus, stomach, large or small intestine); and a normal physical examination.

You may not qualify if:

• History of a motility disorder (including, but not limited to, achalasia, gastroparesis)
• History of peptic ulcer disease
• Symptoms referable to gastric dysmotility (nausea, vomiting, early satiety, heartburn, postprandial abdominal distension)
• Use of medications that may affect GI motor function (beta adrenergic receptor blockers, calcium channel blockers, histamine type 2 receptor antagonists, proton pump inhibitors, prokinetic agents, antidepressants, and the use of narcotic analgesics)
• Regular use of nonsteroidal anti-inflammatory medications
• Use of monoamine oxidase inhibitors
• Pregnancy or breast feeding
• Prior gastrointestinal surgery (except appendectomy)

Sponsors & Collaborators

• Temple University: lead

Study Sites (1)

Temple University School of Medicine

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

Dyspepsia

Interventions

Desipramine; Amitriptyline

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Henry P Parkman, MD

  Temple University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2005
• First Posted: September 22, 2005
• Study Start: September 1, 2005
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: March 5, 2021

Record last verified: 2021-03

Locations

US (1)