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Lack of recruitment
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| Name | Class |
|---|---|
| American College of Gastroenterology | OTHER |
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Adult diabetic patients (ages 18-65) with gastric emptying scintigraphy-confirmed delayed gastric emptying will be recruited to participate in the study. Using double-blinded methodology, study participants will be randomly assigned to one of two treatment arms: promethazine 12.5 mg three times daily for 28 days or placebo three times daily for 28 days. The primary outcome will be the change in gastroparesis symptom severity, as measured by the Gastroparesis Cardinal Symptom Index (GCSI) at four weeks compared to baseline. Participants will be seen for a clinic evaluation at weeks 0, 2 and 4, during which symptom scores, adverse events and treatment compliance will be assessed. It is hypothesized promethazine treatment will be superior to placebo in improving symptoms of gastroparesis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Promethazine | Experimental | Promethazine 12.5 mg P.O. t.i.d. for 4 weeks |
|
| Sugar Pill | Placebo Comparator | Placebo P.O. t.i.d. for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Promethazine | Drug |
|
| |
| Sugar pill |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient-reported Symptoms as Measured by the Gastroparesis Cardinal Symptom Index Score (GCSI, 14) From Week 0 to Week 4. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Adverse Events | 4 weeks | |
| Use of Rescue Medication | Frequency of use of the "rescue medication" meclizine | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian E. Lacy, MD | Dartmouth-Hitchcock Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22118574 | Background | Cherian D, Parkman HP. Nausea and vomiting in diabetic and idiopathic gastroparesis. Neurogastroenterol Motil. 2012 Mar;24(3):217-22, e103. doi: 10.1111/j.1365-2982.2011.01828.x. Epub 2011 Nov 27. | |
| 24005344 | Background | Janssen P, Harris MS, Jones M, Masaoka T, Farre R, Tornblom H, Van Oudenhove L, Simren M, Tack J. The relation between symptom improvement and gastric emptying in the treatment of diabetic and idiopathic gastroparesis. Am J Gastroenterol. 2013 Sep;108(9):1382-91. doi: 10.1038/ajg.2013.118. |
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Participants were recruited from the gastroenterology clinic at Dartmouth-Hitchcock Medical Center at the time of routine appointments.
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| ID | Title | Description |
|---|---|---|
| FG000 | Promethazine | Promethazine 12.5 mg P.O. t.i.d. for 4 weeks Promethazine |
| FG001 | Sugar Pill | Placebo P.O. t.i.d. for 4 weeks Sugar pill |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Promethazine | Promethazine 12.5 mg P.O. t.i.d. for 4 weeks Promethazine |
| BG001 | Sugar Pill | Placebo P.O. t.i.d. for 4 weeks Sugar pill |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Patient-reported Symptoms as Measured by the Gastroparesis Cardinal Symptom Index Score (GCSI, 14) From Week 0 to Week 4. | Insufficient recruitment resulting in insufficient data to analyze | Posted | 4 weeks |
|
|
From date of ICF signature through study completion, approximately 5 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Promethazine | Promethazine 12.5 mg P.O. t.i.d. for 4 weeks Promethazine | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Auditory Hallucinations | Psychiatric disorders | Non-systematic Assessment |
Insufficient enrollment to provide study results. Study terminated before full enrollment due to lack of participant interest.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gastroenterology Research Team Lead | Dartmouth-Hitchcock | 603-653-9033 | Jessica.I.Chevalier@hitchcock.org |
Not provided
| ID | Term |
|---|---|
| D011398 | Promethazine |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D010640 | Phenothiazines |
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| Drug |
|
|
| The Impact on Work Activity as Measured by the Work Productivity and Activity Impairment Questionnaire. (WPAI). |
| 4 weeks |
| 3884697 | Background | Ricci DA, Saltzman MB, Meyer C, Callachan C, McCallum RW. Effect of metoclopramide in diabetic gastroparesis. J Clin Gastroenterol. 1985 Feb;7(1):25-32. doi: 10.1097/00004836-198502000-00003. |
| 6400707 | Background | McCallum RW, Ricci DA, Rakatansky H, Behar J, Rhodes JB, Salen G, Deren J, Ippoliti A, Olsen HW, Falchuk K, et al. A multicenter placebo-controlled clinical trial of oral metoclopramide in diabetic gastroparesis. Diabetes Care. 1983 Sep-Oct;6(5):463-7. doi: 10.2337/diacare.6.5.463. |
| 385260 | Background | Perkel MS, Moore C, Hersh T, Davidson ED. Metoclopramide therapy in patients with delayed gastric emptying: a randomized, double-blind study. Dig Dis Sci. 1979 Sep;24(9):662-6. doi: 10.1007/BF01314461. |
| 7065559 | Background | Snape WJ Jr, Battle WM, Schwartz SS, Braunstein SN, Goldstein HA, Alavi A. Metoclopramide to treat gastroparesis due to diabetes mellitus: a double-blind, controlled trial. Ann Intern Med. 1982 Apr;96(4):444-6. doi: 10.7326/0003-4819-96-4-444. |
| 10235199 | Background | Patterson D, Abell T, Rothstein R, Koch K, Barnett J. A double-blind multicenter comparison of domperidone and metoclopramide in the treatment of diabetic patients with symptoms of gastroparesis. Am J Gastroenterol. 1999 May;94(5):1230-4. doi: 10.1111/j.1572-0241.1999.00456.x. |
| 8299441 | Background | Erbas T, Varoglu E, Erbas B, Tastekin G, Akalin S. Comparison of metoclopramide and erythromycin in the treatment of diabetic gastroparesis. Diabetes Care. 1993 Nov;16(11):1511-4. doi: 10.2337/diacare.16.11.1511. |
| 1618070 | Background | McHugh S, Lico S, Diamant NE. Cisapride vs metoclopramide. An acute study in diabetic gastroparesis. Dig Dis Sci. 1992 Jul;37(7):997-1001. doi: 10.1007/BF01300277. |
| 3781184 | Background | Feldman M, Smith HJ. Effect of cisapride on gastric emptying of indigestible solids in patients with gastroparesis diabeticorum. A comparison with metoclopramide and placebo. Gastroenterology. 1987 Jan;92(1):171-4. doi: 10.1016/0016-5085(87)90854-7. |
| 23735907 | Background | Ehrenpreis ED, Deepak P, Sifuentes H, Devi R, Du H, Leikin JB. The metoclopramide black box warning for tardive dyskinesia: effect on clinical practice, adverse event reporting, and prescription drug lawsuits. Am J Gastroenterol. 2013 Jun;108(6):866-72. doi: 10.1038/ajg.2012.300. |
| 20410771 | Background | Tan PC, Khine PP, Vallikkannu N, Omar SZ. Promethazine compared with metoclopramide for hyperemesis gravidarum: a randomized controlled trial. Obstet Gynecol. 2010 May;115(5):975-981. doi: 10.1097/AOG.0b013e3181d99290. |
| 18304050 | Background | Braude D, Crandall C. Ondansetron versus promethazine to treat acute undifferentiated nausea in the emergency department: a randomized, double-blind, noninferiority trial. Acad Emerg Med. 2008 Mar;15(3):209-15. doi: 10.1111/j.1553-2712.2008.00060.x. |
| 12848636 | Background | Revicki DA, Rentz AM, Dubois D, Kahrilas P, Stanghellini V, Talley NJ, Tack J. Development and validation of a patient-assessed gastroparesis symptom severity measure: the Gastroparesis Cardinal Symptom Index. Aliment Pharmacol Ther. 2003 Jul 1;18(1):141-50. doi: 10.1046/j.1365-2036.2003.01612.x. |
| 22284754 | Background | Revicki DA, Camilleri M, Kuo B, Szarka LA, McCormack J, Parkman HP. Evaluating symptom outcomes in gastroparesis clinical trials: validity and responsiveness of the Gastroparesis Cardinal Symptom Index-Daily Diary (GCSI-DD). Neurogastroenterol Motil. 2012 May;24(5):456-63, e215-6. doi: 10.1111/j.1365-2982.2012.01879.x. Epub 2012 Jan 27. |
| 15298641 | Background | Reilly MC, Bracco A, Ricci JF, Santoro J, Stevens T. The validity and accuracy of the Work Productivity and Activity Impairment questionnaire--irritable bowel syndrome version (WPAI:IBS). Aliment Pharmacol Ther. 2004 Aug 15;20(4):459-67. doi: 10.1111/j.1365-2036.2004.02091.x. |
| 11918826 | Background | Wahlqvist P, Carlsson J, Stalhammar NO, Wiklund I. Validity of a Work Productivity and Activity Impairment questionnaire for patients with symptoms of gastro-esophageal reflux disease (WPAI-GERD)--results from a cross-sectional study. Value Health. 2002 Mar-Apr;5(2):106-13. doi: 10.1046/j.1524-4733.2002.52101.x. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Participants |
|
| Secondary | Occurrence of Adverse Events | Insufficient recruitment resulting in insufficient data to analyze | Posted | 4 weeks |
|
|
| Secondary | Use of Rescue Medication | Frequency of use of the "rescue medication" meclizine | Data not collected | Posted | 4 weeks |
|
|
| Secondary | The Impact on Work Activity as Measured by the Work Productivity and Activity Impairment Questionnaire. (WPAI). | Insufficient recruitment resulting in insufficient data to analyze | Posted | 4 weeks |
|
|
| 2 |
| 0 |
| 2 |
| 1 |
| 2 |
| EG001 | Sugar Pill | Placebo P.O. t.i.d. for 4 weeks Sugar pill | 0 | 1 | 0 | 1 | 0 | 1 |
| Nightmares | Psychiatric disorders | Non-systematic Assessment |
|
| Chest Pain | Cardiac disorders | Non-systematic Assessment |
|
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| D013457 |
| Sulfur Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002241 | Carbohydrates |