Trial Outcomes & Findings for Octreotide Compared to Placebo in Patients With Inoperable Bowel Obstruction Due to Peritoneal Carcinomatosis (NCT NCT00332696)

Last Updated: 2011-09-23

Results Overview

Treatment Success was defined as: less than 2 episodes of vomiting on average per day for the 4 days prior to Day 14 \[from Day 10 to Day 13\] and no use of an Nasogastric Tube (NGT) since at least Day 10 and no use of an anticholinergic agent until Day 14. Treatment Failure is defined as: 2 or more episodes of vomiting per day on average for the 4 days prior to Day 14 or use of an NGT after Day 9 or use of an anticholinergic agent before Day 14 or withdrawal from the trial between Day 1 and Day 14 (included), whatever the cause.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

64 participants

Primary outcome timeframe

Day 10 to Day 13

Results posted on

2011-09-23

Participant Flow

Participant milestones

Participant milestones
Measure	Octreotide Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.	Placebo Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
Overall Study STARTED	32	32
Overall Study Completed Day 14 Visit	21	15
Overall Study COMPLETED	2	2
Overall Study NOT COMPLETED	30	30

Reasons for withdrawal

Reasons for withdrawal
Measure	Octreotide Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.	Placebo Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
Overall Study Death	24	14
Overall Study Insufficient therapeutic effect	4	11
Overall Study Adverse Event	1	2
Overall Study Condition does not justify treatment	0	2
Overall Study Lost to Follow-up	0	1
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Octreotide Compared to Placebo in Patients With Inoperable Bowel Obstruction Due to Peritoneal Carcinomatosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Octreotide n=32 Participants Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.	Placebo n=32 Participants Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.	Total n=64 Participants Total of all reporting groups
Age Continuous	65.3 years STANDARD_DEVIATION 9.57 • n=5 Participants	63.1 years STANDARD_DEVIATION 12.36 • n=7 Participants	64.2 years STANDARD_DEVIATION 11.02 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	21 Participants n=7 Participants	46 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	11 Participants n=7 Participants	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 10 to Day 13

Population: Intent-to-treat population consisted of all randomized participants who received at least one dose of study drug.

Outcome measures

Outcome measures
Measure	Octreotide n=32 Participants Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.	Placebo n=32 Participants Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
Number of Participants With Treatment Success From Day 10 to Day 13 TREATMENT SUCCESS	12 Participants	9 Participants
Number of Participants With Treatment Success From Day 10 to Day 13 Vomiting episodes <2 (per day)	19 Participants	13 Participants
Number of Participants With Treatment Success From Day 10 to Day 13 Vomiting episodes ≥2 (per day)	2 Participants	2 Participants
Number of Participants With Treatment Success From Day 10 to Day 13 No Nasogastric Tube since Day 10	14 Participants	13 Participants
Number of Participants With Treatment Success From Day 10 to Day 13 Nasogastric Tube used since Day 10	7 Participants	2 Participants
Number of Participants With Treatment Success From Day 10 to Day 13 No Anticholinergic agents	18 Participants	11 Participants
Number of Participants With Treatment Success From Day 10 to Day 13 Anticholinergic agents taken	3 Participants	4 Participants
Number of Participants With Treatment Success From Day 10 to Day 13 Premature discontinuation/missing data, failure	11 Participants	17 Participants

SECONDARY outcome

Timeframe: Day 5 to Day 7

Population: Intent-to-treat population consisted of all randomized participants who received at least one dose of study drug.

Day 7 treatment success was defined as improvement of symptoms in the previous 2 days (average number of vomiting episodes less than 2 from Day 5, no Nasogastric Tube (NGT) since Day 5 and no anticholinergic agent or withdrawal from trial).

Outcome measures

Outcome measures
Measure	Octreotide n=32 Participants Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.	Placebo n=32 Participants Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
Number of Participants With Treatment Success From Day 5 to Day 7 TREATMENT SUCCESS	22 Participants	20 Participants
Number of Participants With Treatment Success From Day 5 to Day 7 Vomiting episodes <2 (per day) since Day 5	28 Participants	25 Participants
Number of Participants With Treatment Success From Day 5 to Day 7 Vomiting episodes ≥2 (per day) since Day 5	1 Participants	2 Participants
Number of Participants With Treatment Success From Day 5 to Day 7 No Nasogastric Tube since Day 5	22 Participants	24 Participants
Number of Participants With Treatment Success From Day 5 to Day 7 Nasogastric Tube used since Day 5	7 Participants	3 Participants
Number of Participants With Treatment Success From Day 5 to Day 7 No Anticholinergic agents	26 Participants	25 Participants
Number of Participants With Treatment Success From Day 5 to Day 7 Anticholinergic agents taken	3 Participants	2 Participants
Number of Participants With Treatment Success From Day 5 to Day 7 Premature discontinuation/missing data	3 Participants	5 Participants

SECONDARY outcome

Timeframe: Day 1, Day 7 and Day 14

Population: Intent-to-treat population consisted of all randomized participants who received study drug. "n" in each of the categories is the number of participants with data at the given time point.

The mean number of vomiting episodes per a 24 hour period is presented for Day 1, Day 7 and Day 14.

Outcome measures

Outcome measures
Measure	Octreotide n=32 Participants Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.	Placebo n=32 Participants Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
Number of Vomiting Episodes Per Day at Day1, Day 2 and Day 14 Day 1	1.2 Vomiting episodes Standard Deviation 2.14	0.6 Vomiting episodes Standard Deviation 1.85
Number of Vomiting Episodes Per Day at Day1, Day 2 and Day 14 Day 7 (n=31,31)	0.3 Vomiting episodes Standard Deviation 0.64	0.4 Vomiting episodes Standard Deviation 0.84
Number of Vomiting Episodes Per Day at Day1, Day 2 and Day 14 Day 14 (n=28,27)	0.3 Vomiting episodes Standard Deviation 0.81	0.5 Vomiting episodes Standard Deviation 2.12

SECONDARY outcome

Timeframe: Day 1

Population: Intent-to-treat population consisted of all randomized participants who received at least one dose of study drug.

Participants rated their nausea intensity on a scale of 0 to 3, with 3 being the worse. The number of participants with a score of 0, a score of 1, a score of 2 and a score of 3 are presented for Day 1.

Outcome measures

Outcome measures
Measure	Octreotide n=32 Participants Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.	Placebo n=32 Participants Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 1 Score=0	16 Participants	13 Participants
Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 1 Score=1	1 Participants	2 Participants
Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 1 Score=2	7 Participants	9 Participants
Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 1 Score=3	8 Participants	8 Participants

SECONDARY outcome

Timeframe: Day 7

Population: Participants from the Intent-to-treat population consisting of all randomized participants who received study drug and for whom data was available at Day 7.

Outcome measures

Outcome measures
Measure	Octreotide n=31 Participants Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.	Placebo n=31 Participants Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 7 Score=0	21 Participants	15 Participants
Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 7 Score=1	2 Participants	9 Participants
Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 7 Score=2	5 Participants	6 Participants
Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 7 Score=3	3 Participants	1 Participants

SECONDARY outcome

Timeframe: Day 14

Population: Participants from the Intent-to-treat population consisting of all randomized participants who received study drug and for whom data was available at Day 14.

Outcome measures

Outcome measures
Measure	Octreotide n=28 Participants Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.	Placebo n=27 Participants Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 14 Score=0	22 Participants	22 Participants
Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 14 Score=1	2 Participants	3 Participants
Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 14 Score=2	2 Participants	1 Participants
Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 14 Score=3	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Day 7 and Day 14

Population: Intent-to-treat population consisted of all randomized participants who received at least one dose of study drug.

Relief from obstruction is defined by combining restart of stools for at least the previous 3 days, less than 2 episodes of vomiting on average for the previous 4 days and the restarting of flatus (gas generated in the stomach or bowels) for at least the previous 12 hours.

Outcome measures

Outcome measures
Measure	Octreotide n=32 Participants Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.	Placebo n=32 Participants Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
Number of Participants With Relief From Obstruction at Day 7 and Day 14 Relief from Obstruction: Day 7	9 Participants	15 Participants
Number of Participants With Relief From Obstruction at Day 7 and Day 14 No Relief from Obstruction: Day 7	20 Participants	12 Participants
Number of Participants With Relief From Obstruction at Day 7 and Day 14 Relief from Obstruction: Day 14	11 Participants	10 Participants
Number of Participants With Relief From Obstruction at Day 7 and Day 14 No Relief from Obstruction: Day 14	10 Participants	5 Participants

SECONDARY outcome

Timeframe: 1 Month

Population: Participants from the Intent-to-treat population (consisting of all randomized participants who received at least one dose of study drug) for whom data was available at Month 1.

Recurrence of bowel obstruction was confirmed by abdominal X-ray.

Outcome measures

Outcome measures
Measure	Octreotide n=14 Participants Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.	Placebo n=15 Participants Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 1 Recurrence at Month 1	1 Participants	2 Participants
Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 1 No Recurrence at Month 1	13 Participants	13 Participants

SECONDARY outcome

Timeframe: Month 2

Population: Participants from the Intent-to-treat population (consisting of all randomized participants who received at least one dose of study drug) for whom data was available at Month 2.

Recurrence of bowel obstruction was confirmed by abdominal X-ray.

Outcome measures

Outcome measures
Measure	Octreotide n=8 Participants Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.	Placebo n=7 Participants Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 2 Recurrence at Month 2	2 Participants	2 Participants
Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 2 No Recurrence at Month 2	6 Participants	5 Participants

SECONDARY outcome

Timeframe: Month 3

Population: Participants from the Intent-to-treat population (consisting of all randomized participants who received at least one dose of study drug) for whom data was available at Month 3.

Recurrence of bowel obstruction was confirmed by abdominal X-ray.

Outcome measures

Outcome measures
Measure	Octreotide n=3 Participants Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.	Placebo n=2 Participants Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 3 Recurrence at Month 3	0 Participants	0 Participants
Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 3 No Recurrence at Month 3	3 Participants	2 Participants

SECONDARY outcome

Timeframe: Day 1, Day 7, Day 14, Month 1, Month 2 and Month 3

Population: Intent-to-treat population consisted of all participants who received at least one dose of study drug. "n" in each of the categories is the number of participants who had Quality of Life data at that time point.

The Edmonton Scale consisted of 9 items: pain, activity, nausea, depression, anxiety, fatigue, appetite, sensation of well-being and dyspnea (difficult or labored breathing). Participants rated these items on a scale of 0 to 10, with 10 being the worse.

Outcome measures

Outcome measures
Measure	Octreotide n=32 Participants Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.	Placebo n=32 Participants Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
Participant's Quality of Life Using the Edmonton Scale Month 3 (n=2,2)	0.05 Scores on a scale Standard Deviation 0.071	1.60 Scores on a scale Standard Deviation 0.283
Participant's Quality of Life Using the Edmonton Scale Day 1 (n=30,29)	4.12 Scores on a scale Standard Deviation 1.174	4.12 Scores on a scale Standard Deviation 1.360
Participant's Quality of Life Using the Edmonton Scale Day 7 (n=24,26)	4.23 Scores on a scale Standard Deviation 1.695	3.37 Scores on a scale Standard Deviation 1.247
Participant's Quality of Life Using the Edmonton Scale Day 14 (n=20,14)	4.30 Scores on a scale Standard Deviation 1.652	3.85 Scores on a scale Standard Deviation 1.860
Participant's Quality of Life Using the Edmonton Scale Month 1 (n=11,13)	4.18 Scores on a scale Standard Deviation 1.905	4.49 Scores on a scale Standard Deviation 1.820
Participant's Quality of Life Using the Edmonton Scale Month 2 (n=7,4)	3.46 Scores on a scale Standard Deviation 2.339	3.23 Scores on a scale Standard Deviation 1.609

Adverse Events

Octreotide

Serious events: 6 serious events

Other events: 24 other events

Deaths: 0 deaths

Placebo

Serious events: 6 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Octreotide n=32 participants at risk Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.	Placebo n=32 participants at risk Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
Cardiac disorders Cardiac arrest	3.1% 1/32	0.00% 0/32
Gastrointestinal disorders Abdominal pain	0.00% 0/32	3.1% 1/32
Gastrointestinal disorders Ascites	3.1% 1/32	0.00% 0/32
Gastrointestinal disorders Intestinal obstruction	0.00% 0/32	3.1% 1/32
Gastrointestinal disorders Vomiting	0.00% 0/32	3.1% 1/32
General disorders Disease progression	0.00% 0/32	3.1% 1/32
General disorders General physical health deterioration	3.1% 1/32	9.4% 3/32
General disorders Hyperthermia	3.1% 1/32	3.1% 1/32
General disorders Oedema	3.1% 1/32	0.00% 0/32
General disorders Oedema peripheral	0.00% 0/32	3.1% 1/32
Hepatobiliary disorders Cholestasis	3.1% 1/32	0.00% 0/32
Hepatobiliary disorders Cytolytic hepatitis	3.1% 1/32	0.00% 0/32
Infections and infestations Sepsis	3.1% 1/32	6.2% 2/32
Infections and infestations Septic shock	3.1% 1/32	3.1% 1/32
Infections and infestations Staphylococcal infection	3.1% 1/32	0.00% 0/32
Metabolism and nutrition disorders Anorexia	0.00% 0/32	3.1% 1/32
Metabolism and nutrition disorders Diabetes mellitus inadequate control	3.1% 1/32	0.00% 0/32
Metabolism and nutrition disorders Hyperglycaemia	3.1% 1/32	0.00% 0/32
Nervous system disorders Coma	3.1% 1/32	0.00% 0/32
Nervous system disorders Depressed level of consciousness	3.1% 1/32	0.00% 0/32
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	3.1% 1/32	0.00% 0/32
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/32	6.2% 2/32
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/32	6.2% 2/32
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/32	3.1% 1/32
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/32	3.1% 1/32
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/32	3.1% 1/32
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/32	3.1% 1/32
Surgical and medical procedures Ileostomy	0.00% 0/32	3.1% 1/32
Surgical and medical procedures Laparotomy	0.00% 0/32	3.1% 1/32
Vascular disorders Hypotension	0.00% 0/32	3.1% 1/32

Other adverse events

Other adverse events
Measure	Octreotide n=32 participants at risk Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.	Placebo n=32 participants at risk Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
Blood and lymphatic system disorders Anaemia	6.2% 2/32	3.1% 1/32
Blood and lymphatic system disorders Thrombocytopenia	3.1% 1/32	6.2% 2/32
Cardiac disorders Cardiogenic shock	0.00% 0/32	6.2% 2/32
Gastrointestinal disorders Abdominal pain	21.9% 7/32	12.5% 4/32
Gastrointestinal disorders Diarrhoea	15.6% 5/32	9.4% 3/32
Gastrointestinal disorders Dyspepsia	9.4% 3/32	0.00% 0/32
Gastrointestinal disorders Gastrooesophageal reflux disease	3.1% 1/32	6.2% 2/32
Gastrointestinal disorders Melaena	0.00% 0/32	6.2% 2/32
Gastrointestinal disorders Nausea	21.9% 7/32	6.2% 2/32
Gastrointestinal disorders Vomiting	18.8% 6/32	15.6% 5/32
General disorders Asthenia	21.9% 7/32	9.4% 3/32
General disorders Chills	6.2% 2/32	0.00% 0/32
General disorders Condition aggravated	9.4% 3/32	3.1% 1/32
General disorders Disease progression	21.9% 7/32	6.2% 2/32
General disorders Fatigue	9.4% 3/32	3.1% 1/32
General disorders General physical health deterioration	9.4% 3/32	9.4% 3/32
General disorders Hypothermia	6.2% 2/32	0.00% 0/32
General disorders Oedema	6.2% 2/32	0.00% 0/32
General disorders Oedema peripheral	6.2% 2/32	9.4% 3/32
General disorders Pain	3.1% 1/32	6.2% 2/32
General disorders Pyrexia	9.4% 3/32	3.1% 1/32
Hepatobiliary disorders Jaundice	6.2% 2/32	3.1% 1/32
Infections and infestations Oral fungal infection	6.2% 2/32	0.00% 0/32
Infections and infestations Sepsis	3.1% 1/32	6.2% 2/32
Infections and infestations Septic shock	6.2% 2/32	3.1% 1/32
Infections and infestations Urinary tract infection	9.4% 3/32	3.1% 1/32
Metabolism and nutrition disorders Diabetes mellitus inadequate control	3.1% 1/32	6.2% 2/32
Metabolism and nutrition disorders Hyperglycaemia	6.2% 2/32	6.2% 2/32
Metabolism and nutrition disorders Hyponatraemia	12.5% 4/32	0.00% 0/32
Musculoskeletal and connective tissue disorders Back pain	6.2% 2/32	0.00% 0/32
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm progression	9.4% 3/32	3.1% 1/32
Nervous system disorders Headache	6.2% 2/32	3.1% 1/32
Psychiatric disorders Anxiety	9.4% 3/32	12.5% 4/32
Psychiatric disorders Confusional state	12.5% 4/32	6.2% 2/32
Psychiatric disorders Disorientation	6.2% 2/32	0.00% 0/32
Psychiatric disorders Insomnia	6.2% 2/32	3.1% 1/32
Renal and urinary disorders Dysuria	6.2% 2/32	0.00% 0/32
Renal and urinary disorders Urinary incontinence	9.4% 3/32	0.00% 0/32
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	0.00% 0/32	9.4% 3/32
Respiratory, thoracic and mediastinal disorders Dyspnoea	15.6% 5/32	9.4% 3/32
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/32	6.2% 2/32
Respiratory, thoracic and mediastinal disorders Productive cough	6.2% 2/32	0.00% 0/32
Skin and subcutaneous tissue disorders Decubitus ulcer	6.2% 2/32	0.00% 0/32
Skin and subcutaneous tissue disorders Erythema	9.4% 3/32	0.00% 0/32
Skin and subcutaneous tissue disorders Hyperhidrosis	6.2% 2/32	0.00% 0/32

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Results disclosure agreements

Principal investigator is a sponsor employee Disclosure Restriction Description: 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 the pooled data (i.e., data from all sites) in the clinical trial; or of the trial results in their entirety.
Publication restrictions are in place

Restriction type: OTHER