Phase 2
N=43
Phase II Study Evaluating Efficacy, Safety and Pharmacokinetics of Pasireotide in Patients With Dumping Syndrome
Dumping Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01637272 ↗Enrolled (actual)
43
Serious AEs
21.1%
Results posted
May 2017
Primary outcome: Primary: Response Rate in Plasma Glucose Level — 60.5 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SOM230 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response Rate in Plasma Glucose Level |
36.4; 39.4 | — |
| SECONDARY Response Rate in Plasma Glucose Level |
36.4; 39.4 | — |
| SECONDARY Response Rate in Pulse Rate |
60.5; 24.2; 24.2; 18.6; 36.4; 27.3 | — |
| SECONDARY Response Rate in Hematocrit Levels |
27.9; 21.2; 21.2; 16.3; 27.3; 24.2 | — |
| SECONDARY Insulin Levels During OGTT |
37.0; 34.7; 29.0; 196.3; 499.8; 294.1 | — |
| SECONDARY Glucagon Levels During OGTT |
20.70; 22.6; 21.4; 20.64; 25.8; 23.8 | — |
| SECONDARY Glucagon-like Peptide 1 (GLP-1) Levels During OGTT |
3.021; 2.1; 1.6; 12.811; 21.0; 17.4 | — |
| SECONDARY Gastric Inhibitory Polypeptide (GIP) Levels at During OGTT |
2.608; 1.5; 1.7; 15.704; 30.3; 24.8 | — |
| SECONDARY Health-related Quality of Live (HRQoL) Short Form- 36 (SF-36) Score(s) |
44.801; 45.306; 46.505; 44.093; 44.838; 47.021 | — |
| SECONDARY Dumping Severity Score (DSS) at the End of Months 3, 6 and 8 |
7.1; 6.8; 9.0; 6.7; 6.4; 6.0 | — |
| SECONDARY Dumping Score Questionnaire (DSQ) at the End of Months 3, 6 and 12 |
9.6; 9.2; 10.7; 4.9; 5.6; 5.7 | — |
| SECONDARY Patient Global Assessment at the End of Months 3, 6 and 12 |
5.1; 5.1; 5.9 | — |
| SECONDARY Plasma Pharmacokinetic (PK) Parameter of Pasireotide: Cmax, ss (Steady State) and Ctrough, ss, After s.c. Injection |
1.49; 3.31; 4.56; 5.62; 0.574; 1.11 | — |
| SECONDARY Plasma Pharmacokinetic (PK) Parameter of Pasireotide: AUC0-3h, ss, After s.c. Injection |
3.04; 6.53; 8.84; 11.5 | — |
| SECONDARY Plasma Pharmacokinetic (PK) Parameter of Pasireotide: Tmax, ss, After s.c. Injection |
0.583; 0.6; 0.583; 0.633 | — |
| SECONDARY Plasma PK Parameter of AUC0-3h, d21, End _inj and AUC0-3h, d28, 3rd_inj Associated With LAR (LAR Core Phase) |
6.92; 14.9; 5.97; 9.3 | — |
| SECONDARY Summary of LAR PK Parameters by Dose |
3.2; 6.2; 2.29; 3.33 | — |
| SECONDARY Pasireotide Concentrations in LAR Phase |
2.25; 4.3; 7.76; NA; NA; 2.91 | — |
| SECONDARY LAR PK Parameter: Ctrough - at Steady State (ss) by Dose |
3.34; 3.76; 8.19; 4.63 | — |
Summary
multi-center, phase II study evaluating efficacy, safety and pharmacokinetics of pasireotide in patients with dumping syndrome
Eligibility Criteria
Inclusion criteria:.
- Male or female patients ≥ 18 years of age.
- Post-gastric or esophageal bypass surgery, matching one of the criteria below:
- Bariatric surgery: more than 6 months before signing the informed consent
- Esophageal cancer surgery: were disease free at study entry
- Gastric cancer surgery: were at stage 0 or I and were disease free at study entry
- Patient with a documented diagnosis of Dumping Syndrome defined as having:
- History of/or active symptoms associated with dumping syndrome (e.g. post-prandial tachycardia, bloating, diarrhea) and
- Documented history of hypoglycemia based on either:
- glucose 2.0 mg/dL
- Alkaline phosphatase (ALP) >2.5 x upper limit of normal (ULN)
- Serum total bilirubin >1.5 x ULN
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >2 x ULN
- History of liver disease, such as cirrhosis or chronic active hepatitis B and C.
- Presence of Hepatitis B surface antigen (HbsAg) and/ or presence of Hepatitis C antibody test (anti-Hepatitis C Virus).
Data sourced from ClinicalTrials.gov (NCT01637272). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.