Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 7 for:    "Postgastrectomy Syndrome" | "Hormones, Hormone Substitutes, and Hormone Antagonists"

Phase II Study Evaluating Efficacy, Safety and Pharmacokinetics of Pasireotide in Patients With Dumping Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01637272
Recruitment Status : Completed
First Posted : July 11, 2012
Results First Posted : May 10, 2017
Last Update Posted : May 10, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Dumping Syndrome
Intervention Drug: SOM230
Enrollment 43
Recruitment Details 43 patients were enrolled as planned; 33 patients completed the core sc phase, 31 patients completed the core LAR phase. Of the 31 patients who completed core LAR phase, 27 patients entered the extension phase. Of the 27 patients who entered the extension phase, 23 patients completed the study.
Pre-assignment Details All patients underwent an OGTT (75g of glucose) and were evaluated at different time points. If the glucose level was <60 mg/dL at 90, 120, 150 or 180 min during the OGTT and all the other eligibility criteria were met, patients were allowed to start study medication. The study was divided in 2 phases, core phase and extension phase.
Arm/Group Title SOM230
Hide Arm/Group Description Subjects with dumping syndrome treated with pasireotide
Period Title: Overall Study
Started 43
Completed sc Phase 33
Completed Core Phase (sc + LAR) 31
Entered Extension Phase 27
Completed Core But Did no Enter Ext.. 4
Completed 23
Not Completed 20
Reason Not Completed
Adverse Event             6
Unsatisfactory therapeutic effect             2
Withdrawal by Subject             3
Lost to Follow-up             2
completed core, did not enter ext. phase             4
Administrative problems             1
Protocol Violation             2
Arm/Group Title SOM230
Hide Arm/Group Description Subjects with dumping syndrome treated with pasireotide
Overall Number of Baseline Participants 43
Hide Baseline Analysis Population Description
The overall study full analysis set (FAS) consisted of all patients who were enrolled in the study (whether treated or not).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 43 participants
45.9  (9.99)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants
Female
38
  88.4%
Male
5
  11.6%
1.Primary Outcome
Title Response Rate in Plasma Glucose Level
Hide Description Response rate is defined as percentage of patients with no glucose values < 60 mg/dL at 90,120, 150 and 180 min during the Oral Glucose Tolerance Test (OGTT) at the end of s.c. dose escalation phase
Time Frame at Month 3 (M3)
Hide Outcome Measure Data
Hide Analysis Population Description
The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase.
Arm/Group Title SOM230 - 3 Months (sc)
Hide Arm/Group Description:
Subjects with dumping syndrome treated with pasireotide sc
Overall Number of Participants Analyzed 43
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
60.5
(44.41 to 75.02)
2.Secondary Outcome
Title Response Rate in Plasma Glucose Level
Hide Description Response rate is defined as percentage of patients with no glucose values < 60 mg/dL at 90,120, 150 and 180 min during the Oral Glucose Tolerance Test (OGTT) at the end of 6 months (end of LAR/Core phase) and at the end of 12 months (extension phase)
Time Frame at Month 6 (M6), Month 12 (M12)
Hide Outcome Measure Data
Hide Analysis Population Description
The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.
Arm/Group Title SOM230- 6 Months (LAR) SOM230 - 12 Months (Ext)
Hide Arm/Group Description:
Subjects with dumping syndrome treated with pasireotide sc (3M)followed by pasireotide LAR (3M) for a total of 6 months
Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core & 6 months in Ext. phase)
Overall Number of Participants Analyzed 33 33
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
36.4
(20.40 to 54.88)
39.4
(22.91 to 57.86)
3.Secondary Outcome
Title Response Rate in Pulse Rate
Hide Description Pulse rate was defined as percentage of patients with change in pulse rate >=10 bpm from pre-OGTT to 30 minutes post OGTT.
Time Frame at baseline, M3, M6, M12
Hide Outcome Measure Data
Hide Analysis Population Description
The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.
Arm/Group Title SOM230 - 3 Months (sc) SOM230 - 6 Months (LAR) SOM230 - 12 Months (Ext)
Hide Arm/Group Description:
Subjects with dumping syndrome treated with pasireotide sc
Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core & 6 months in Ext. phase)
Overall Number of Participants Analyzed 43 33 33
Measure Type: Number
Unit of Measure: Percentage of participants
rate ≥ 10 bpm at baseline 60.5 24.2 24.2
rate ≥ 10 bpm at post-baseline 18.6 36.4 27.3
4.Secondary Outcome
Title Response Rate in Hematocrit Levels
Hide Description Percentage of patients with change in hematocrit >= 3% from pre-OGTT to 30 minutes post OGTT.
Time Frame M3, M6, M12
Hide Outcome Measure Data
Hide Analysis Population Description
The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.
Arm/Group Title SOM230 - 3 Months (sc) SOM230 - 6 Months (LAR) SOM230 - 12 Months (Ext)
Hide Arm/Group Description:
Subjects with dumping syndrome treated with pasireotide sc
Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core & 6 months in Ext. phase)
Overall Number of Participants Analyzed 43 33 33
Measure Type: Number
Unit of Measure: Percentage of participants
hematocrit >= 3% at baseline 27.9 21.2 21.2
hematocrit >= 3% at post baseline 16.3 27.3 24.2
5.Secondary Outcome
Title Insulin Levels During OGTT
Hide Description Absolute insulin levels at the end of M3, M6, M12
Time Frame M3, M6, M12
Hide Outcome Measure Data
Hide Analysis Population Description
The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.
Arm/Group Title SOM230 - 3 Months (sc) SOM230 - 6 Months (LAR) SOM230 - 12 Months (Ext)
Hide Arm/Group Description:
Subjects with dumping syndrome treated with pasireotide sc
Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core & 6 months in Ext. phase)
Overall Number of Participants Analyzed 43 33 33
Mean (Standard Deviation)
Unit of Measure: pmol/L
Pre-OGTT (n= 31, 29, 21) 37.0  (24.55) 34.7  (19.73) 29.0  (14.43)
30 Minutes (n=30, 29, 23) 196.3  (253.10) 499.8  (276.80) 294.1  (177.25)
60 Minutes (n= 31, 30, 22) 367.5  (354.73) 573.2  (428.46) 602.1  (381.6)
90 Minutes (n=31, 30, 22) 309.1  (263.92) 420.4  (544.78) 472.0  (438.82)
120 Minutes(n=32, 30, 22) 183.7  (209.90) 205.7  (514.45) 195.1  (247.43)
150 Minutes(n=33, 30, 22) 103.2  (166.67) 102.8  (228.92) 76.0  (106.05)
180 Minutes (n=32, 29, 22) 58.5  (52.65) 69.1  (154.11) 52.0  (58.81)
6.Secondary Outcome
Title Glucagon Levels During OGTT
Hide Description Absolute glucagon levels at the end of Months 3, 6 & 12
Time Frame M3, M6, M12
Hide Outcome Measure Data
Hide Analysis Population Description
The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.
Arm/Group Title SOM230 - 3 Months (sc) SOM230 - 6 Months (LAR) SOM230 - 12 Months (Ext)
Hide Arm/Group Description:
Subjects with dumping syndrome treated with pasireotide sc
Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core & 6 months in Ext. phase)
Overall Number of Participants Analyzed 43 33 33
Mean (Standard Deviation)
Unit of Measure: pmol/L
Pre-OGTT (n= 31, 30, 23) 20.70  (6.162) 22.6  (5.85) 21.4  (6.82)
30 Minutes (n= 33, 29, 22) 20.64  (7.037) 25.8  (6.57) 23.8  (6.97)
60 Minutes (n= 33, 28, 22) 20.80  (7.330) 23.7  (5.76) 22.9  (7.07)
90 Minutes (n= 32, 29, 22) 20.07  (7.898) 22.7  (5.16) 21.5  (7.69)
120 Minutes (n= 32, 29, 22) 19.73  (7.369) 23.1  (5.40) 22.0  (7.31)
150 Minutes (n= 32 28, 22) 19.94  (7.169) 23.7  (6.67) 21.8  (7.27)
180 Minutes (n= 32, 29, 22) 20.16  (7.097) 22.7  (5.45) 22.3  (6.58)
7.Secondary Outcome
Title Glucagon-like Peptide 1 (GLP-1) Levels During OGTT
Hide Description Absolute Glucagon-like peptide 1 (GLP-1) levels at the end of at the end of Months 3, 6 and 12 at different time points.
Time Frame M3, M6, M12
Hide Outcome Measure Data
Hide Analysis Population Description
The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.
Arm/Group Title SOM230 - 3 Months (sc) SOM230 - 6 Months (LAR) SOM230 - 12 Months (Ext)
Hide Arm/Group Description:
Subjects with dumping syndrome treated with pasireotide sc
Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core & 6 months in Ext. phase)
Overall Number of Participants Analyzed 43 33 33
Mean (Standard Deviation)
Unit of Measure: pmol/L
Pre-OGTT (n=31, 29, 23) 3.021  (2.1936) 2.1  (1.37) 1.6  (1.26)
30 Minutes(n=32, 29, 22) 12.811  (6.6194) 21.0  (18.01) 17.4  (17.64)
60 Minutes (n= 32, 30, 22) 11.208  (11.1218) 14.6  (18.44) 12.6  (8.76)
90 Minutes (n=31, 29, 22) 6.986  (4.9729) 8.2  (4.96) 7.2  (3.71)
120 Minutes (n=31, 29, 22) 5.003  (4.1183) 5.2  (3.94) 5.0  (2.98)
150 Minutes(n=31, 29, 22) 3.565  (2.3879) 4.2  (4.20) 3.7  (2.46)
180 Minutes (n=31, 29, 22) 2.974  (1.9902) 3.3  (3.49) 3.2  (2.44)
8.Secondary Outcome
Title Gastric Inhibitory Polypeptide (GIP) Levels at During OGTT
Hide Description Absolute Gastric Inhibitory Polypeptide (GIP) levels at the end of Months 3, 6 and 12 at different time points.
Time Frame M3, M6, M12
Hide Outcome Measure Data
Hide Analysis Population Description

The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase.

The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.

Arm/Group Title SOM230 - 3 Months (sc) SOM230 - 6 Months (LAR) SOM230 - 12 Months (Ext)
Hide Arm/Group Description:
Subjects with dumping syndrome treated with pasireotide sc
Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core & 6 months in Ext. phase)
Overall Number of Participants Analyzed 43 33 33
Mean (Standard Deviation)
Unit of Measure: pmol/L
Pre-OGTT (n=31, 29, 23) 2.608  (1.7441) 1.5  (1.00) 1.7  (1.51)
30 Minutes (n=32, 29, 22) 15.704  (10.6395) 30.3  (19.73) 24.8  (18.88)
60 Minutes (n= 32, 30, 22) 9.471  (6.1861) 14.3  (13.37) 11.6  (9.05)
90 Minutes(n=31, 29, 22) 4.141  (2.8978) 6.5  (7.32) 5.2  (5.18)
120 Minutes (n=31, 29, 22) 2.089  (1.4681) 2.4  (1.73) 3.0  (2.81)
150 Minutes (n=30, 29, 22) 1.376  (1.2049) 2.1  (3.22) 1.9  (1.44)
180 Minutes (n=31, 29, 22) 1.260  (1.2218) 3.8  (12.77) 2.5  (3.72)
9.Secondary Outcome
Title Health-related Quality of Live (HRQoL) Short Form- 36 (SF-36) Score(s)
Hide Description Absolute HRQoL SF-36 Scores at end of the Months 3, 6 and 12 from s.c. baseline. SF-36, a 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting. Items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.
Time Frame M3, M6, M12
Hide Outcome Measure Data
Hide Analysis Population Description
The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.
Arm/Group Title SOM230 - 3 Months (sc) SOM230 - 6 Months (LAR) SOM230 - 12 Months (Ext)
Hide Arm/Group Description:
Subjects with dumping syndrome treated with pasireotide sc
Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core & 6 months in Ext. phase)
Overall Number of Participants Analyzed 43 33 33
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Physical Component Summary (n=35, 29, 23) 44.801  (8.3378) 45.306  (9.5622) 46.505  (8.5105)
Mental Component Summary (n=35, 29, 23) 44.093  (12.2144) 44.838  (11.6573) 47.021  (11.5053)
10.Secondary Outcome
Title Dumping Severity Score (DSS) at the End of Months 3, 6 and 8
Hide Description Absolute Dumping Severity Score (DSS) scores at end of M3, M6 & M8. At study start patients were assessed using DSS (older version of DSQ); however after the implementation of protocol amendment 2, all patients were expected to use DSQ. No results available for M12 as last patient that answered the DSS was at M8. DSS = disease-specific patient (Pt.) reported outcome (PRO) questionnaire uses a 4-point Likert scale (0, absent; 1, mild; 2, relevant; 3, severe; 4) to ask Pt. to evaluate intensity of early dumping symptoms (within 30 minutes (<30 minutes) after food ingestion). The questionnaire also evaluates 65 late dumping symptoms (more than 1.5 hours (>90 minutes) after food ingestion). Early & late dumping score calculated by adding the scores of the respective questions. Cumulative dumping score is obtained by adding early & late scores. DSS Range (min (absent) – max (severe)): Early dumping: 0-24; Late Dumping: 0-18; Cumulative: 0-42. Lower scores represent a better outcome.
Time Frame M3, M6, M8
Hide Outcome Measure Data
Hide Analysis Population Description
The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.
Arm/Group Title SOM230 - 3 Months (sc) SOM230 - 6 Months (LAR) SOM230 - 8 Months (Ext)
Hide Arm/Group Description:
Subjects with dumping syndrome treated with pasireotide sc
Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core & 6 months in Ext. phase)
Overall Number of Participants Analyzed 43 33 33
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Early symptoms (n=20, 9, 2) 7.1  (6.38) 6.8  (6.46) 9.0  (8.49)
Late symptoms (n=20, 9, 2) 6.7  (5.42) 6.4  (5.27) 6.0  (4.24)
Overall score (n=20, 9, 2) 13.7  (11.11) 13.2  (10.65) 15.0  (12.73)
11.Secondary Outcome
Title Dumping Score Questionnaire (DSQ) at the End of Months 3, 6 and 12
Hide Description Absolute Dumping Score Questionnaire (DSQ) scores at end of Months 3, 6 & 12 from s.c. baseline. DSQ = disease-specific PRO scale. The questionnaire uses a 5-point Likert scale (0, none; 1, mild; 2, moderate; 3, severe; 4, very severe) to ask Pt. to evaluate intensity of 10 early dumping symptoms (within 30 minutes (<30 minutes) after food ingestion). The questionnaire also evaluates 5 late dumping symptoms (more than 1.5 hours (>90 minutes) after food ingestion). Early & late dumping score calculated by adding the scores of respective questions. A cumulative dumping score is obtained by adding early & late scores. At study start patients were assessed using DSS (older version of DSQ); however after the implementation of protocol amendment 2, all patients used DSQ. DSQ Range: (min (None) – max (Very severe)): Early dumping: 0-40; Late Dumping: 0-20; Cumulative: 0-60. Lower scores represent a better outcome.
Time Frame M3, M6, M12
Hide Outcome Measure Data
Hide Analysis Population Description
The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.
Arm/Group Title SOM230 - 3 Months (sc) SOM230 - 6 Months (LAR) SOM230 - 12 Months (Ext)
Hide Arm/Group Description:
Subjects with dumping syndrome treated with pasireotide sc
Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core & 6 months in Ext. phase)
Overall Number of Participants Analyzed 43 33 33
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Early symptoms (n=15, 20, 23) 9.6  (10.27) 9.2  (10.05) 10.7  (10.94)
Late symptoms (n=15, 20, 23) 4.9  (5.37) 5.6  (6.57) 5.7  (5.93)
Overall score (n=15, 20, 23) 14.5  (15.26) 14.8  (14.65) 16.3  (16.23)
12.Secondary Outcome
Title Patient Global Assessment at the End of Months 3, 6 and 12
Hide Description

Treatment with pasireotide LAR (both early and late dumping scores), was assessed by patient global assessment. Patient Global Assessment served as an additional approach to symptom based measurement by DSQ. It incorporated a patient global assessment question:

“Considering all the ways that your disease affects you, rate how you are feeling during the last 7 days compared with your situation before starting the study” .Patients Global Assessment was measured utilizing a 7 point scale (from 1=a lot worse to 7= a lot better).

Time Frame M3, M6, M12
Hide Outcome Measure Data
Hide Analysis Population Description
The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.
Arm/Group Title SOM230 - 3 Months (sc) SOM230 - 6 Months (LAR) SOM230 - 12 Months (Ext)
Hide Arm/Group Description:
Subjects with dumping syndrome treated with pasireotide sc
Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core & 6 months in Ext. phase)
Overall Number of Participants Analyzed 35 29 23
Mean (Standard Deviation)
Unit of Measure: scores on a scale
5.1  (1.19) 5.1  (1.27) 5.9  (0.95)
13.Secondary Outcome
Title Plasma Pharmacokinetic (PK) Parameter of Pasireotide: Cmax, ss (Steady State) and Ctrough, ss, After s.c. Injection
Hide Description A pre-dose PK blood sample was collected before the morning pasireotide s.c. dose of 50 μg, 100 ug, 150 ug and 200 ug. OGTT was performed right after the morning s.c. dose (Time point zero); additional PK blood samples were collected at the same time points as the OGTT evaluation at 30, 60, 90, 120, 150 and 180 minutes. 'n' = number of subjects with non-missing values
Time Frame M1 to M3
Hide Outcome Measure Data
Hide Analysis Population Description
The sc PK analysis set consisted of all patients who received at least one of the scheduled full daily sc dose (3 injections) and had evaluable PK data (concentration) in the sc dose escalation phase of the study (Visit 2 through Visit 8).
Arm/Group Title SOM sc 50 ug t.i.d. SOM sc 100 ug t.i.d. SOM sc 150 ug t.i.d. SOM sc 200 ug t.i.d.
Hide Arm/Group Description:
Subjects with dumping syndrome treated with pasireotide sc 50 ug t.i.d. for 3 months
Subjects with dumping syndrome treated with pasireotide sc 100 ug t.i.d. for 3 months
Subjects with dumping syndrome treated with pasireotide sc 150 ug t.i.d. for 3 months
Subjects with dumping syndrome treated with pasireotide sc 200 ug t.i.d.
Overall Number of Participants Analyzed 40 31 23 14
Mean (Standard Deviation)
Unit of Measure: ng/mL
Cmax, ss (n=35, 28, 18, 10) 1.49  (0.613) 3.31  (1.78) 4.56  (2.22) 5.62  (3.18)
Ctrough, ss (n=37, 30, 22, 12) 0.574  (0.436) 1.11  (0.909) 1.5  (0.798) 2.03  (1.54)
14.Secondary Outcome
Title Plasma Pharmacokinetic (PK) Parameter of Pasireotide: AUC0-3h, ss, After s.c. Injection
Hide Description A pre-dose PK blood sample was collected before the morning pasireotide s.c. dose of 50 μg, 100 ug, 150 ug and 200 ug. OGTT was performed right after the morning s.c. dose (Time point zero); additional PK blood samples were collected at the same time points as the OGTT evaluation at 30, 60, 90, 120, 150 and 180 minutes.
Time Frame M1 to M3
Hide Outcome Measure Data
Hide Analysis Population Description
The sc PK analysis set consisted of all patients who received at least one of the scheduled full daily sc dose (3 injections) and had evaluable PK data (concentration) in the sc dose escalation phase of the study (Visit 2 through Visit 8).
Arm/Group Title SOM sc 50 ug t.i.d. SOM sc 100 ug t.i.d. SOM sc 150 ug t.i.d. SOM sc 200 ug t.i.d.
Hide Arm/Group Description:
Subjects with dumping syndrome treated with pasireotide sc 50 ug t.i.d. for 3 months
Subjects with dumping syndrome treated with pasireotide sc 100 ug t.i.d. for 3 months
Subjects with dumping syndrome treated with pasireotide sc 150 ug t.i.d. for 3 months
Subjects with dumping syndrome treated with pasireotide sc 200 ug t.i.d.
Overall Number of Participants Analyzed 36 28 18 10
Mean (Standard Deviation)
Unit of Measure: hr*ng/mL
3.04  (1.13) 6.53  (3.45) 8.84  (3.89) 11.5  (6.23)
15.Secondary Outcome
Title Plasma Pharmacokinetic (PK) Parameter of Pasireotide: Tmax, ss, After s.c. Injection
Hide Description A pre-dose PK blood sample was collected before the morning pasireotide s.c. dose of 50 μg, 100 ug, 150 ug and 200 ug. OGTT was performed right after the morning s.c. dose (Time point zero); additional PK blood samples were collected at the same time points as the OGTT evaluation at 30, 60, 90, 120, 150 and 180 minutes.
Time Frame M1 to M3
Hide Outcome Measure Data
Hide Analysis Population Description
The sc PK analysis set consisted of all patients who received at least one of the scheduled full daily sc dose (3 injections) and had evaluable PK data (concentration) in the sc dose escalation phase of the study (Visit 2 through Visit 8).
Arm/Group Title SOM sc 50 ug t.i.d. SOM sc 100 ug t.i.d. SOM sc 150 ug t.i.d. SOM sc 200 ug t.i.d.
Hide Arm/Group Description:
Subjects with dumping syndrome treated with pasireotide sc 50 ug t.i.d. for 3 months
Subjects with dumping syndrome treated with pasireotide sc 100 ug t.i.d. for 3 months
Subjects with dumping syndrome treated with pasireotide sc 150 ug t.i.d. for 3 months
Subjects with dumping syndrome treated with pasireotide sc 200 ug t.i.d.
Overall Number of Participants Analyzed 36 28 20 11
Median (Full Range)
Unit of Measure: hr
0.583
(0 to 1.58)
0.6
(0 to 2.1)
0.583
(0.5 to 2.6)
0.633
(0.5 to 1.22)
16.Secondary Outcome
Title Plasma PK Parameter of AUC0-3h, d21, End _inj and AUC0-3h, d28, 3rd_inj Associated With LAR (LAR Core Phase)
Hide Description [Not Specified]
Time Frame M4 to M6
Hide Outcome Measure Data
Hide Analysis Population Description
The LAR PK analysis set consisted of all patients who received at least one of the scheduled full monthly im LAR injections and had evaluable PK data (concentration) in the LAR phase of the study (Visit 9 through end of LAR phase visit).
Arm/Group Title SOM LAR 10mg SOM LAR 20mg
Hide Arm/Group Description:
Subjects with dumping syndrome treated with pasireotide LAR 10mg
Subjects with dumping syndrome treated with pasireotide LAR 20mg
Overall Number of Participants Analyzed 14 19
Mean (Standard Deviation)
Unit of Measure: hr*ng/mL
AUC0-3h,d21, 2nd injection (n = 12, 14) 6.92  (4.12) 14.9  (6.71)
AUC0-3h,d28, 3rd_injection (n = 9, 16) 5.97  (2.41) 9.3  (4.11)
17.Secondary Outcome
Title Summary of LAR PK Parameters by Dose
Hide Description Summary of plasma PK parameter Cmax, p2 , 2nd injection and Ctrough, d28 associated with LAR injection (LAR Core phase)
Time Frame M4 to M6
Hide Outcome Measure Data
Hide Analysis Population Description
The LAR PK analysis set consisted of all patients who received at least one of the scheduled full monthly im LAR injections and had evaluable PK data (concentration) in the LAR phase of the study (Visit 9 through end of LAR phase visit).
Arm/Group Title SOM LAR 10mg SOM LAR 20mg
Hide Arm/Group Description:
Subjects with dumping syndrome treated with pasireotide LAR 10mg
Subjects with dumping syndrome treated with pasireotide LAR 20mg
Overall Number of Participants Analyzed 14 19
Mean (Standard Deviation)
Unit of Measure: ng/mL
Cmax, p2, 2nd_inj (n = 10, 13) 3.2  (1.55) 6.2  (2.6)
Ctrough (n= 14, 19) 2.29  (1.05) 3.33  (1.34)
18.Secondary Outcome
Title Pasireotide Concentrations in LAR Phase
Hide Description Summary of pasireotide concentrations following monthly i.m. injections of pasireotide LAR by incident dose (LAR Pharmacokinetic set)
Time Frame M7 to M12
Hide Outcome Measure Data
Hide Analysis Population Description
The LAR PK analysis set consisted of all patients who received at least one of the scheduled full monthly im LAR injections and had evaluable PK data (concentration) in the LAR phase of the study (Visit 9 through end of LAR phase visit).
Arm/Group Title SOM LAR 10mg SOM LAR 20mg SOM LAR 30mg SOM LAR 40mg SOM LAR 60mg
Hide Arm/Group Description:
Subjects with dumping syndrome treated with pasireotide LAR 10mg
Subjects with dumping syndrome treated with pasireotide LAR 20mg
Subjects with dumping syndrome treated with pasireotide LAR 30mg
Subjects with dumping syndrome treated with pasireotide LAR 40mg
Subjects with dumping syndrome treated with pasireotide LAR 60mg
Overall Number of Participants Analyzed 6 12 17 9 3
Mean (Standard Deviation)
Unit of Measure: ng/mL
M7 - 0hr (pre-dose) (n = 4, 11, 11, 0, 0) 2.25  (1.56) 4.3  (2.19) 7.76  (4.31) NA [1]   (NA) NA [2]   (NA)
M8 - 0hr (pre-dose) (n = 5, 7, 11, 0, 0) 2.91  (2.42) 3.77  (1.57) 6.5  (2.91) NA [1]   (NA) NA [1]   (NA)
M9 - 0hr (pre-dose) (n = 5, 6, 9, 6, 0) 2.97  (1.68) 4.01  (2.27) 6.38  (3.15) 7.53  (4.45) NA [1]   (NA)
M10 - 0hr (pre-dose) (n = 5, 6, 8, 5, 0) 3.53  (1.75) 5.48  (3.62) 8.38  (2.81) 11.8  (8.26) NA [1]   (NA)
M11 - 0hr (pre-dose) (n = 5, 4, 8, 4, 3) 3.45  (1.98) 3.48  (0.772) 7.99  (3.54) 6.53  (1.83) 17.9  (7.15)
M12 - 0hr (pre-dose) (n = 5, 3, 8, 4, 3) 3.27  (2.02) 4.63  (1.04) 10.3  (6.05) 6.55  (2.05) 18.1  (13.8)
[1]
N/A = No participants took this dose hence no data
[2]
N/A =No participants took this dose hence no data
19.Secondary Outcome
Title LAR PK Parameter: Ctrough - at Steady State (ss) by Dose
Hide Description In the LAR treatment phase, monthly injections of pasireotide LAR 10, 20, 30 and 40 mg were given to participants and trough concentration at steady state (Ctrough,ss) were obtained but due to only 1 participant in the 40mg arm, standard deviation could not be calculated.
Time Frame M4 to M12
Hide Outcome Measure Data
Hide Analysis Population Description
The LAR PK analysis set consisted of all patients who received at least one of the scheduled full monthly im LAR injections and had evaluable PK data (concentration) in the LAR phase of the study (Visit 9 through end of LAR phase visit).
Arm/Group Title SOM LAR 10mg SOM LAR 20mg SOM LAR 30mg SOM LAR 40mg
Hide Arm/Group Description:
Subjects with dumping syndrome treated with pasireotide LAR 10mg
Subjects with dumping syndrome treated with pasireotide LAR 20mg
Subjects with dumping syndrome treated with pasireotide LAR 30mg
Subjects with dumping syndrome treated with pasireotide LAR 40mg
Overall Number of Participants Analyzed 6 6 6 1
Mean (Standard Deviation)
Unit of Measure: ng/mL
3.34  (1.52) 3.76  (1.48) 8.19  (3.22) 4.63 [1]   (NA)
[1]
N/A - due to only one participant at LAR 40 mg, Ctrough,ss for this arm was not enough to a standard deviation
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title s.c. Phase LAR Phase
Hide Arm/Group Description s.c. phase was made up of subjects with dumping syndrome who entered the study and were treated with pasireotide s.c. LAR phase was made up of subjects with dumping syndrome who completed the s.c. phase, entered the LAR phase and were treated with pasireotide LAR
All-Cause Mortality
s.c. Phase LAR Phase
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
s.c. Phase LAR Phase
Affected / at Risk (%) Affected / at Risk (%)
Total   6/43 (13.95%)   10/33 (30.30%) 
Blood and lymphatic system disorders     
Haemorrhagic anaemia  1  0/43 (0.00%)  1/33 (3.03%) 
Gastrointestinal disorders     
Abdominal adhesions  1  0/43 (0.00%)  2/33 (6.06%) 
Abdominal pain  1  1/43 (2.33%)  1/33 (3.03%) 
Abdominal pain upper  1  0/43 (0.00%)  1/33 (3.03%) 
Dysphagia  1  0/43 (0.00%)  1/33 (3.03%) 
Small intestinal obstruction  1  2/43 (4.65%)  0/33 (0.00%) 
General disorders     
Asthenia  1  0/43 (0.00%)  1/33 (3.03%) 
Immune system disorders     
Anaphylactic reaction  1  1/43 (2.33%)  0/33 (0.00%) 
Infections and infestations     
Subdiaphragmatic abscess  1  0/43 (0.00%)  1/33 (3.03%) 
Metabolism and nutrition disorders     
Hypoglycaemia  1  2/43 (4.65%)  1/33 (3.03%) 
Malnutrition  1  0/43 (0.00%)  1/33 (3.03%) 
Nervous system disorders     
Headache  1  0/43 (0.00%)  1/33 (3.03%) 
Paraesthesia  1  0/43 (0.00%)  1/33 (3.03%) 
Sciatica  1  0/43 (0.00%)  1/33 (3.03%) 
Visual field defect  1  0/43 (0.00%)  1/33 (3.03%) 
Psychiatric disorders     
Depression  1  0/43 (0.00%)  1/33 (3.03%) 
Mental status changes  1  0/43 (0.00%)  1/33 (3.03%) 
Renal and urinary disorders     
Acute kidney injury  1  1/43 (2.33%)  0/33 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory failure  1  0/43 (0.00%)  1/33 (3.03%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, 18.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
s.c. Phase LAR Phase
Affected / at Risk (%) Affected / at Risk (%)
Total   31/43 (72.09%)   25/33 (75.76%) 
Blood and lymphatic system disorders     
Anaemia  1  0/43 (0.00%)  2/33 (6.06%) 
Cardiac disorders     
Angina pectoris  1  3/43 (6.98%)  0/33 (0.00%) 
Palpitations  1  3/43 (6.98%)  0/33 (0.00%) 
Gastrointestinal disorders     
Abdominal distension  1  4/43 (9.30%)  1/33 (3.03%) 
Abdominal pain  1  7/43 (16.28%)  7/33 (21.21%) 
Abdominal pain upper  1  5/43 (11.63%)  3/33 (9.09%) 
Constipation  1  3/43 (6.98%)  0/33 (0.00%) 
Diarrhoea  1  9/43 (20.93%)  8/33 (24.24%) 
Dyspepsia  1  0/43 (0.00%)  2/33 (6.06%) 
Nausea  1  6/43 (13.95%)  6/33 (18.18%) 
Steatorrhoea  1  4/43 (9.30%)  0/33 (0.00%) 
Vomiting  1  3/43 (6.98%)  3/33 (9.09%) 
General disorders     
Asthenia  1  5/43 (11.63%)  4/33 (12.12%) 
Chills  1  1/43 (2.33%)  2/33 (6.06%) 
Fatigue  1  3/43 (6.98%)  8/33 (24.24%) 
Injection site pain  1  4/43 (9.30%)  1/33 (3.03%) 
Injection site reaction  1  3/43 (6.98%)  0/33 (0.00%) 
Oedema peripheral  1  0/43 (0.00%)  2/33 (6.06%) 
Thirst  1  3/43 (6.98%)  0/33 (0.00%) 
Hepatobiliary disorders     
Cholelithiasis  1  0/43 (0.00%)  5/33 (15.15%) 
Infections and infestations     
Bronchitis  1  1/43 (2.33%)  2/33 (6.06%) 
Gastroenteritis  1  0/43 (0.00%)  2/33 (6.06%) 
Nasopharyngitis  1  3/43 (6.98%)  6/33 (18.18%) 
Sinusitis  1  0/43 (0.00%)  2/33 (6.06%) 
Injury, poisoning and procedural complications     
Contusion  1  0/43 (0.00%)  3/33 (9.09%) 
Fall  1  0/43 (0.00%)  2/33 (6.06%) 
Post-traumatic pain  1  0/43 (0.00%)  2/33 (6.06%) 
Rib fracture  1  0/43 (0.00%)  2/33 (6.06%) 
Investigations     
Weight increased  1  3/43 (6.98%)  2/33 (6.06%) 
Metabolism and nutrition disorders     
Hyperglycaemia  1  2/43 (4.65%)  3/33 (9.09%) 
Hypoglycaemia  1  5/43 (11.63%)  9/33 (27.27%) 
Hypophosphataemia  1  0/43 (0.00%)  2/33 (6.06%) 
Iron deficiency  1  2/43 (4.65%)  5/33 (15.15%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  3/43 (6.98%)  4/33 (12.12%) 
Muscle spasms  1  2/43 (4.65%)  4/33 (12.12%) 
Nervous system disorders     
Dizziness  1  4/43 (9.30%)  0/33 (0.00%) 
Headache  1  10/43 (23.26%)  9/33 (27.27%) 
Syncope  1  0/43 (0.00%)  2/33 (6.06%) 
Psychiatric disorders     
Anxiety  1  0/43 (0.00%)  2/33 (6.06%) 
Depressed mood  1  1/43 (2.33%)  2/33 (6.06%) 
Depression  1  3/43 (6.98%)  1/33 (3.03%) 
Insomnia  1  0/43 (0.00%)  3/33 (9.09%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  0/43 (0.00%)  2/33 (6.06%) 
Hyperhidrosis  1  3/43 (6.98%)  2/33 (6.06%) 
Vascular disorders     
Haematoma  1  1/43 (2.33%)  2/33 (6.06%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, 18.0
All safety parameters were analyzed by study phase (sc/LAR)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
EMail: trialandresults.registries@novartis.com
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01637272     History of Changes
Other Study ID Numbers: CSOM230X2203
2012-001534-34 ( EudraCT Number )
First Submitted: May 9, 2012
First Posted: July 11, 2012
Results First Submitted: July 29, 2016
Results First Posted: May 10, 2017
Last Update Posted: May 10, 2017