scholarly journals Granisetron Transdermal System for Gastroparesis: A Prospective Study using the GCSI-Daily Diary

2018 ◽  
Vol 4 (1) ◽  
Author(s):  
Jason Heckert ◽  
Ron Schey ◽  
Henry Paul Parkman
Keyword(s):  
Abdominal Pain ◽  
Daily Diary ◽  
Open Label ◽  
Symptom Index ◽  
Early Satiety ◽  
Postprandial Fullness ◽  
Fda Guidance ◽  
Idiopathic Gastroparesis ◽  
A Prospective Study ◽  
Cardinal Symptom

Granisetron transdermal system (GTS; Sancuso®), a patch delivering a 5-HT3 receptor antagonist, has been shown to improve nausea and vomiting in gastroparesis. Recent FDA guidance on gastroparesis suggests daily scoring of symptoms to show efficacy. Aim: Determine the efficacy and onset of therapeutic response of GTS in improving specific symptoms and overall symptoms of gastroparesis in patients with gastroparesis using a daily symptom diary for gastroparesis. Methods: Symptomatic patients with diabetic or idiopathic gastroparesis with nausea and/or vomiting were enrolled. Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) captured severity of symptoms at baseline for one week and during two weeks of treatment with GTS. Key Results: 14 patients (age 41.5±17 years; 13 females) with refractory gastroparesis (5 idiopathic, 9 diabetic) participated in this open label study. Nausea, early satiety, postprandial fullness, abdominal pain, GCSI-DD composite score, and overall symptom severity significantly improved (p<0.05) during treatment when compared to the baseline week. Nausea significantly decreased on day 5 (p<0.01) of treatment. Episodes of vomiting did not significantly change. Side effects included pruritus (2 patients) and redness (1) at the patch site, headache (1), constipation (1), and poor patch adherence (5). Conclusions & Inferences: GTS significantly reduced nausea severity in patients with gastroparesis. There were also significant improvements in early satiety, postprandial fullness, and abdominal pain. Nausea improvement occurred on the fifth day of treatment. Thus, GTS has therapeutic effect on nausea, as well as other gastroparesis symptoms, in patients with gastroparesis as captured using a daily diary for gastroparesis.

scholarly journals Development and content validity of a gastroparesis cardinal symptom index daily diary

2009 ◽  
Vol 30 (6) ◽  
pp. 670-680 ◽  
Author(s):  
D. A. REVICKI ◽  
M. CAMILLERI ◽  
B. KUO ◽  
N. J. NORTON ◽  
L. MURRAY ◽  
...  
Keyword(s):  
Content Validity ◽  
Daily Diary ◽  
Symptom Index ◽  
Cardinal Symptom

M1216 Gastroparesis Cardinal Symptom Index (GCSI): Use of a Daily Diary Versus Two Week Recall

2009 ◽  
Vol 136 (5) ◽  
pp. A-374-A-375
Author(s):  
Henry P. Parkman ◽  
Michael Camilleri ◽  
Braden Kuo ◽  
Nancy J. Norton ◽  
Susmita Paladugu ◽  
...  
Keyword(s):  
Daily Diary ◽  
Symptom Index ◽  
Cardinal Symptom

T1267 Content Validity of a Gastroparesis Cardinal Symptom Index Daily Diary

2009 ◽  
Vol 136 (5) ◽  
pp. A-535-A-536
Author(s):  
Dennis A. Revicki ◽  
Michael Camilleri ◽  
Braden Kuo ◽  
Nancy J. Norton ◽  
Lindsey Murray ◽  
...  
Keyword(s):  
Content Validity ◽  
Daily Diary ◽  
Symptom Index ◽  
Cardinal Symptom

scholarly journals Efficacy and Safety of Tradipitant in Diabetic and Idiopathic Gastroparesis: A Randomized, Placebo-Controlled Study

2020 ◽  
Author(s):  
Jesse L. Carlin ◽  
V. Rose Lieberman ◽  
Arya Dahal ◽  
Madison S. Keefe ◽  
Changfu Xiao ◽  
...  
Keyword(s):  
Unmet Need ◽  
Nausea And Vomiting ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Symptom Index ◽  
Idiopathic Gastroparesis ◽  
Patient Reported ◽  
Cardinal Symptom ◽  
To Receive

AbstractBackground and AimsThere is a high unmet need for the treatment of gastroparesis and studies of NK1-R antagonists suggest potential benefit in reducing the symptoms of nausea and vomiting. We hypothesized that tradipitant, an NK1-R antagonist, would be effective in treating patients with idiopathic or diabetic gastroparesis.MethodsIn a randomized, double-blind, placebo-controlled study across 47 U.S. sites, 152 gastroparesis patients were randomized to receive oral 85mg BID tradipitant (n=77) or placebo (n=75) daily for four weeks. Symptoms were assessed using a daily symptom dairy, Gastroparesis Cardinal Symptom Index (GCSI), and other patient reported questionnaires.ResultsPatients receiving tradipitant had a significant decrease in nausea score at Week 4 compared to placebo (−1.2 improvement vs −0.7, respectively, p=0.0099), and a significant increase in nausea-free days (28.8% increase on tradipitant vs 15.0% on placebo p=0.0160). Patients with both nausea and vomiting at baseline (n=101) showed an even greater decrease in nausea score (−1.4 improvement on tradipitant vs −0.4 on placebo p<0.0001) and an increase in nausea free days (32.3% improvement on tradipitant vs 7.6% on placebo p=0.0003). 32.9% of patients treated with tradipitant were nausea responders (average nausea score ≤ 1 at week 4) compared to 11.8% of patients on placebo (p=0.0013). 46.6% of patients treated with tradipitant had a greater than 1-point improvement in GCSI score compared to 23.5% of patients on placebo (p=0.0053).ConclusionsTradipitant treatment resulted in statistically and clinically meaningful improvements in nausea and overall gastroparesis symptoms. These robust efficacy results suggest tradipitant has the potential to become a useful pharmacological treatment for gastroparesis.

scholarly journals Gastric peroral endoscopic pyloromyotomy for decompensated gastroparesis: comprehensive motility analysis in relation to treatment outcomes

2021 ◽  
Vol 09 (02) ◽  
pp. E137-E144
Author(s):  
José M. Conchillo ◽  
Jan Willem A. Straathof ◽  
Zlatan Mujagic ◽  
Jenny H. Brouns ◽  
Nicole D. Bouvy ◽  
...  
Keyword(s):  
Clinical Response ◽  
Technical Success ◽  
Open Label ◽  
Motor Patterns ◽  
Symptom Index ◽  
Open Label Study ◽  
Technical Success Rate ◽  
Duodenal Motility ◽  
Predictors Of Response ◽  
Cardinal Symptom

Abstract Background and study aims There are no reliable data to predict which patients with gastroparesis (GP) would benefit the most from gastric peroral endoscopic pyloromyotomy (G-POEM). The aim of the present study was to assess whether antro-duodenal motility patterns and pyloric distensibility can predict the outcome of G-POEM in patients with decompensated GP. Patients and methods In an open-label study, patients with GP and refractory symptoms were eligible for treatment with G-POEM if treatment attempts according to a standardized stepwise protocol had failed. Baseline assessment included Gastroparesis Cardinal Symptom Index (GCSI), C13-octanoic gastric emptying breath test and high-resolution antro-duodenal manometry. Pyloric distensibility using EndoFlip measurements was assessed at baseline and 3 months after the procedure. Explorative analyses were performed on potential predictors of response using logistic regression analyses. Results Twenty-four patients with decompensated GP underwent G-POEM. At baseline, 78.3 % and 61.9 % of patients showed antral hypomotility and neuropathic motor patterns, respectively. The technical success rate was 100 % (24/24). Mean GCSI improved significantly at 3, 6, and 12 months after G-POEM (P = 0.01). Median distensibility index (DI) improved significantly as compared with baseline (7.5 [6.9;11.7] vs. 5.3[3.1;8.1], P = 0.004). A significant correlation was found between clinical response at 6 months and pyloric DI improvement (P = 0.003). No potential predictors of clinical response after G-POEM could be identified in an explorative analysis. Conclusions G-POEM improved pyloric distensibility patterns in patients with decompensated GP. Clinical response at 6 months after G-POEM was associated with pyloric distensibility improvement. However, no potential predictors of response could be identified from either antro-duodenal motility patterns or pyloric distensibility.

scholarly journals W1391 Reliability and Validity of the Gastroparesis Cardinal Symptom Index-Daily Diary

2010 ◽  
Vol 138 (5) ◽  
pp. S-714
Author(s):  
Henry P. Parkman ◽  
Braden Kuo ◽  
Lawrence A. Szarka ◽  
Julie McCormack ◽  
Michael Camilleri ◽  
...  
Keyword(s):  
Reliability And Validity ◽  
Daily Diary ◽  
Symptom Index ◽  
Cardinal Symptom
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