Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00220844
Status:
TERMINATED
Last Update Posted:
2021-03-05
First Post:
2005-09-19
Brief Title:
Tricyclic Antidepressants TCAs on Gastric Emptying
Sponsor:
Temple University
Organization:
Temple University
Study Overview
Official Title:
Effect of Tricyclic Antidepressant Agents on Gastric Accommodation and Emptying
Status:
TERMINATED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Futility study coordinator left and were unable to continue data collection missing data
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
The normal control subjects will be randomized to receive either amitriptyline or desipramine as the tricyclic antidepressant agent with 30 subjects per group Subjects will undergo two outpatient gastric emptyingvolume tests and two satiety tests one of each after 7 days of treatment with oral consumption of the study agent and the other one of each after 7 days of treatment with placebo The order of the treatments active drug or placebo will be randomized with 7 days washout between the studies During the study the subjects will consume their regular diet Subjects will also be randomized to receive either amitriptyline 25 mg po qhs as the active drug or desipramine 25 mg po qhs as the active drug Side effects of the agents will be monitored during the study
Each subject will undergo a brief history and physical exam prior to entering the study The subject will have height and weight measured A questionnaire will be administered to the subject inquiring about gastrointestinal symptoms and medical history This is to screen for a history of underlying pulmonary cardiovascular or gastrointestinal disease Females will be studied only during the follicular phase days 1-10 of the menstrual cycle to minimize the effect of the menstrual cycle on motility Wald at al In addition females will be given pregnancy screening with a urine beta-human chorionic gonadotropin pregnancy test Sure-Vue Fisher Scientific Inc prior to the start of the study
For the simultaneous gastric volumeemptying tests subjects will be studied in the fasting condition The study subject history and physical examination form will be filled out which captures information on symptoms for the last week An intravenous line will be started The subject will take study medication with a small sip of water After 10 minutes 10 mCi 99mTc pertechnetate will be infused intravenously over 30 seconds Imaging of the stomach will be performed with a gamma camera 20 minutes after injection with both anterior and posterior imaging followed by SPECT imaging using the General Electric Dual Head MAXXUS General Electric Medical Systems connected to a General Electric Starcam 4000i computer A total of 360o rotation around the subject will be obtained using a circular orbit 32 stops at 15 sec per stop with the heads for the camera close to the subject After this the patient will ingest an egg sandwich labeled with 300 µCi 111Indium-oxine cooked into the eggs to label the solid material The subject will consume 300 ml of unlabelled water Imaging will then commence immediately after meal ingestion time 0 for 111In counts to assess solid-phase gastric emptying using both anterior and posterior imaging This will be followed immediately by imaging for the 99mTc counts to assess gastric volumes Imaging for 99mTc will be performed with SPECT 3-D imaging These will be repeated at 20 40 60 80 100 120 150 180 210 and 240 minutes after the meal ingestion Our prior studies show that 4 hour gastric emptying best characterizes gastric emptying Peak gastric accommodation occurs at 0-40 minutes At the time of each imaging symptoms will be monitored Symptoms of abdominal fullness nausea abdominal discomfort and bloating will be graded by the study subject from 0 none to 5 severe In addition an inquiry into possible side effects to TCAs sedation confusion disturbed concentration dry mouth constipation nausea and urinary retention will be made
On the next day the subject will return in a fasting condition for the satiety test The methods are similar to those of Tack et al and Chial et al The subject will take their study medication After 30 minutes the subject will drink the nutrient drink Ensure at a rate of 100 ml every 5 minutes until the subject feels completely full After each 100 ml symptoms will be monitored scoring the symptoms of satiety fullness nausea abdominal discomfort and bloating on a scale of 0-5 The volume of Ensure consumed by the subject will be recorded
Each subject will undergo a brief history and physical exam prior to entering the study The subject will have height and weight measured A questionnaire will be administered to the subject inquiring about gastrointestinal symptoms and medical history This is to screen for a history of underlying pulmonary cardiovascular or gastrointestinal disease Females will be studied only during the follicular phase days 1-10 of the menstrual cycle to minimize the effect of the menstrual cycle on motility Wald at al In addition females will be given pregnancy screening with a urine beta-human chorionic gonadotropin pregnancy test Sure-Vue Fisher Scientific Inc prior to the start of the study
For the simultaneous gastric volumeemptying tests subjects will be studied in the fasting condition The study subject history and physical examination form will be filled out which captures information on symptoms for the last week An intravenous line will be started The subject will take study medication with a small sip of water After 10 minutes 10 mCi 99mTc pertechnetate will be infused intravenously over 30 seconds Imaging of the stomach will be performed with a gamma camera 20 minutes after injection with both anterior and posterior imaging followed by SPECT imaging using the General Electric Dual Head MAXXUS General Electric Medical Systems connected to a General Electric Starcam 4000i computer A total of 360o rotation around the subject will be obtained using a circular orbit 32 stops at 15 sec per stop with the heads for the camera close to the subject After this the patient will ingest an egg sandwich labeled with 300 µCi 111Indium-oxine cooked into the eggs to label the solid material The subject will consume 300 ml of unlabelled water Imaging will then commence immediately after meal ingestion time 0 for 111In counts to assess solid-phase gastric emptying using both anterior and posterior imaging This will be followed immediately by imaging for the 99mTc counts to assess gastric volumes Imaging for 99mTc will be performed with SPECT 3-D imaging These will be repeated at 20 40 60 80 100 120 150 180 210 and 240 minutes after the meal ingestion Our prior studies show that 4 hour gastric emptying best characterizes gastric emptying Peak gastric accommodation occurs at 0-40 minutes At the time of each imaging symptoms will be monitored Symptoms of abdominal fullness nausea abdominal discomfort and bloating will be graded by the study subject from 0 none to 5 severe In addition an inquiry into possible side effects to TCAs sedation confusion disturbed concentration dry mouth constipation nausea and urinary retention will be made
On the next day the subject will return in a fasting condition for the satiety test The methods are similar to those of Tack et al and Chial et al The subject will take their study medication After 30 minutes the subject will drink the nutrient drink Ensure at a rate of 100 ml every 5 minutes until the subject feels completely full After each 100 ml symptoms will be monitored scoring the symptoms of satiety fullness nausea abdominal discomfort and bloating on a scale of 0-5 The volume of Ensure consumed by the subject will be recorded
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None