Peritoneal Neoplasms, Intestinal Obstruction, Carcinomatosis
Conditions
Keywords
bowel obstruction,, peritoneal carcinomatosis, Octreotide, inoperable
Brief summary
To evaluate in combination with corticosteroid and local standard medical care the efficacy and safety of long-acting octreotide compared to placebo for the treatment of symptoms of inoperable bowel obstruction in patients with peritoneal carcinomatosis
Interventions
DRUGOctreotide LAR
Octreotide long-acting release (LAR) 30 mg intramuscular injection.
DRUGOctreotide (Immediate release)
Immediate-release Octreotide supplied in 100 µg/mL ampules.
DRUGmethylprednisolone
methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections).
DRUGPlacebo
Physiologic saline solution
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with symptoms and signs of inoperable bowel obstruction confirmed by a surgeon or clinic and radiographic assessment (CT scan or at least abdominal X-ray); * Confirmed peritoneal carcinomatosis (with one of the following criteria : surgery, imaging and/or cytology); * No corticotherapy at dose more than 1mg/kg equivalent-methylprednisolone, in the previous 2 weeks ; * No chemotherapy in the previous week; * No radio or chemotherapy planned at the inclusion and within the two weeks following inclusion * Authorized concomitant treatments for local standard medical care : antiemetics, antispasmodics, anti-Histamine2 (H2) drugs blockers or proton pump inhibitor, analgesics; nasogastric tube
Exclusion criteria
* Abnormal coagulation (prothrombin time \< 60%, platelets \< 50x10\^9/L). * Non authorized concomitant treatments : 1. Anticholinergics such as scopolamine 2. Other somatostatin analogues Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Success From Day 10 to Day 13 | Day 10 to Day 13 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Vomiting Episodes Per Day at Day1, Day 2 and Day 14 | Day 1, Day 7 and Day 14 | The mean number of vomiting episodes per a 24 hour period is presented for Day 1, Day 7 and Day 14. |
| Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 1 | Day 1 | 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. |
| Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 7 | Day 7 | 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 7. |
| Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 14 | Day 14 | 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 14. |
| Number of Participants With Treatment Success From Day 5 to Day 7 | Day 5 to Day 7 | 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). |
| Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 1 | 1 Month | Recurrence of bowel obstruction was confirmed by abdominal X-ray. |
| Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 2 | Month 2 | Recurrence of bowel obstruction was confirmed by abdominal X-ray. |
| Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 3 | Month 3 | Recurrence of bowel obstruction was confirmed by abdominal X-ray. |
| Participant's Quality of Life Using the Edmonton Scale | Day 1, Day 7, Day 14, Month 1, Month 2 and Month 3 | 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. |
| Number of Participants With Relief From Obstruction at Day 7 and Day 14 | Day 7 and Day 14 | 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. |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 32 |
| 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. | 32 |
| Total | 64 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 |
| Overall Study | Condition does not justify treatment | 0 | 2 |
| Overall Study | Death | 24 | 14 |
| Overall Study | Insufficient therapeutic effect | 4 | 11 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Octreotide | Placebo | Total |
|---|---|---|---|
| Age Continuous | 65.3 years STANDARD_DEVIATION 9.57 | 63.1 years STANDARD_DEVIATION 12.36 | 64.2 years STANDARD_DEVIATION 11.02 |
| Sex: Female, Male Female | 25 Participants | 21 Participants | 46 Participants |
| Sex: Female, Male Male | 7 Participants | 11 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 24 / 32 | 19 / 32 |
| serious Total, serious adverse events | 6 / 32 | 6 / 32 |
Outcome results
Primary
Number of Participants With Treatment Success From Day 10 to Day 13
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.
Time frame: Day 10 to Day 13
Population: Intent-to-treat population consisted of all randomized participants who received at least one dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Octreotide | Number of Participants With Treatment Success From Day 10 to Day 13 | Nasogastric Tube used since Day 10 | 7 Participants |
| Octreotide | Number of Participants With Treatment Success From Day 10 to Day 13 | TREATMENT SUCCESS | 12 Participants |
| Octreotide | Number of Participants With Treatment Success From Day 10 to Day 13 | No Anticholinergic agents | 18 Participants |
| Octreotide | Number of Participants With Treatment Success From Day 10 to Day 13 | Vomiting episodes ≥2 (per day) | 2 Participants |
| Octreotide | Number of Participants With Treatment Success From Day 10 to Day 13 | Anticholinergic agents taken | 3 Participants |
| Octreotide | Number of Participants With Treatment Success From Day 10 to Day 13 | Vomiting episodes <2 (per day) | 19 Participants |
| Octreotide | Number of Participants With Treatment Success From Day 10 to Day 13 | Premature discontinuation/missing data, failure | 11 Participants |
| Octreotide | Number of Participants With Treatment Success From Day 10 to Day 13 | No Nasogastric Tube since Day 10 | 14 Participants |
| Placebo | Number of Participants With Treatment Success From Day 10 to Day 13 | Premature discontinuation/missing data, failure | 17 Participants |
| Placebo | Number of Participants With Treatment Success From Day 10 to Day 13 | TREATMENT SUCCESS | 9 Participants |
| Placebo | Number of Participants With Treatment Success From Day 10 to Day 13 | Vomiting episodes <2 (per day) | 13 Participants |
| Placebo | Number of Participants With Treatment Success From Day 10 to Day 13 | Vomiting episodes ≥2 (per day) | 2 Participants |
| Placebo | Number of Participants With Treatment Success From Day 10 to Day 13 | Nasogastric Tube used since Day 10 | 2 Participants |
| Placebo | Number of Participants With Treatment Success From Day 10 to Day 13 | No Anticholinergic agents | 11 Participants |
| Placebo | Number of Participants With Treatment Success From Day 10 to Day 13 | Anticholinergic agents taken | 4 Participants |
| Placebo | Number of Participants With Treatment Success From Day 10 to Day 13 | No Nasogastric Tube since Day 10 | 13 Participants |
Secondary
Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 1
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.
Time frame: Day 1
Population: Intent-to-treat population consisted of all randomized participants who received at least one dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Octreotide | Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 1 | Score=0 | 16 Participants |
| Octreotide | Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 1 | Score=1 | 1 Participants |
| Octreotide | Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 1 | Score=2 | 7 Participants |
| Octreotide | Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 1 | Score=3 | 8 Participants |
| Placebo | Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 1 | Score=3 | 8 Participants |
| Placebo | Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 1 | Score=0 | 13 Participants |
| Placebo | Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 1 | Score=2 | 9 Participants |
| Placebo | Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 1 | Score=1 | 2 Participants |
Secondary
Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 14
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 14.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Octreotide | Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 14 | Score=0 | 22 Participants |
| Octreotide | Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 14 | Score=1 | 2 Participants |
| Octreotide | Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 14 | Score=2 | 2 Participants |
| Octreotide | Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 14 | Score=3 | 2 Participants |
| Placebo | Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 14 | Score=3 | 1 Participants |
| Placebo | Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 14 | Score=0 | 22 Participants |
| Placebo | Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 14 | Score=2 | 1 Participants |
| Placebo | Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 14 | Score=1 | 3 Participants |
Secondary
Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 7
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 7.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Octreotide | Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 7 | Score=0 | 21 Participants |
| Octreotide | Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 7 | Score=1 | 2 Participants |
| Octreotide | Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 7 | Score=2 | 5 Participants |
| Octreotide | Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 7 | Score=3 | 3 Participants |
| Placebo | Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 7 | Score=3 | 1 Participants |
| Placebo | Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 7 | Score=0 | 15 Participants |
| Placebo | Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 7 | Score=2 | 6 Participants |
| Placebo | Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 7 | Score=1 | 9 Participants |
Secondary
Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 1
Recurrence of bowel obstruction was confirmed by abdominal X-ray.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Octreotide | Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 1 | Recurrence at Month 1 | 1 Participants |
| Octreotide | Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 1 | No Recurrence at Month 1 | 13 Participants |
| Placebo | Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 1 | Recurrence at Month 1 | 2 Participants |
| Placebo | Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 1 | No Recurrence at Month 1 | 13 Participants |
Secondary
Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 2
Recurrence of bowel obstruction was confirmed by abdominal X-ray.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Octreotide | Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 2 | No Recurrence at Month 2 | 6 Participants |
| Octreotide | Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 2 | Recurrence at Month 2 | 2 Participants |
| Placebo | Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 2 | Recurrence at Month 2 | 2 Participants |
| Placebo | Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 2 | No Recurrence at Month 2 | 5 Participants |
Secondary
Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 3
Recurrence of bowel obstruction was confirmed by abdominal X-ray.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Octreotide | Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 3 | Recurrence at Month 3 | 0 Participants |
| Octreotide | Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 3 | No Recurrence at Month 3 | 3 Participants |
| Placebo | Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 3 | Recurrence at Month 3 | 0 Participants |
| Placebo | Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 3 | No Recurrence at Month 3 | 2 Participants |
Secondary
Number of Participants With Relief From Obstruction at Day 7 and Day 14
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.
Time frame: Day 7 and Day 14
Population: Intent-to-treat population consisted of all randomized participants who received at least one dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Octreotide | Number of Participants With Relief From Obstruction at Day 7 and Day 14 | Relief from Obstruction: Day 7 | 9 Participants |
| Octreotide | Number of Participants With Relief From Obstruction at Day 7 and Day 14 | No Relief from Obstruction: Day 7 | 20 Participants |
| Octreotide | Number of Participants With Relief From Obstruction at Day 7 and Day 14 | Relief from Obstruction: Day 14 | 11 Participants |
| Octreotide | Number of Participants With Relief From Obstruction at Day 7 and Day 14 | No Relief from Obstruction: Day 14 | 10 Participants |
| Placebo | Number of Participants With Relief From Obstruction at Day 7 and Day 14 | No Relief from Obstruction: Day 14 | 5 Participants |
| Placebo | Number of Participants With Relief From Obstruction at Day 7 and Day 14 | Relief from Obstruction: Day 7 | 15 Participants |
| Placebo | Number of Participants With Relief From Obstruction at Day 7 and Day 14 | Relief from Obstruction: Day 14 | 10 Participants |
| Placebo | Number of Participants With Relief From Obstruction at Day 7 and Day 14 | No Relief from Obstruction: Day 7 | 12 Participants |
Secondary
Number of Participants With Treatment Success From Day 5 to Day 7
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).
Time frame: Day 5 to Day 7
Population: Intent-to-treat population consisted of all randomized participants who received at least one dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Octreotide | Number of Participants With Treatment Success From Day 5 to Day 7 | TREATMENT SUCCESS | 22 Participants |
| Octreotide | Number of Participants With Treatment Success From Day 5 to Day 7 | Vomiting episodes <2 (per day) since Day 5 | 28 Participants |
| Octreotide | Number of Participants With Treatment Success From Day 5 to Day 7 | Vomiting episodes ≥2 (per day) since Day 5 | 1 Participants |
| Octreotide | Number of Participants With Treatment Success From Day 5 to Day 7 | No Nasogastric Tube since Day 5 | 22 Participants |
| Octreotide | Number of Participants With Treatment Success From Day 5 to Day 7 | Nasogastric Tube used since Day 5 | 7 Participants |
| Octreotide | Number of Participants With Treatment Success From Day 5 to Day 7 | No Anticholinergic agents | 26 Participants |
| Octreotide | Number of Participants With Treatment Success From Day 5 to Day 7 | Anticholinergic agents taken | 3 Participants |
| Octreotide | Number of Participants With Treatment Success From Day 5 to Day 7 | Premature discontinuation/missing data | 3 Participants |
| Placebo | Number of Participants With Treatment Success From Day 5 to Day 7 | Premature discontinuation/missing data | 5 Participants |
| Placebo | Number of Participants With Treatment Success From Day 5 to Day 7 | TREATMENT SUCCESS | 20 Participants |
| Placebo | Number of Participants With Treatment Success From Day 5 to Day 7 | Nasogastric Tube used since Day 5 | 3 Participants |
| Placebo | Number of Participants With Treatment Success From Day 5 to Day 7 | Vomiting episodes <2 (per day) since Day 5 | 25 Participants |
| Placebo | Number of Participants With Treatment Success From Day 5 to Day 7 | Anticholinergic agents taken | 2 Participants |
| Placebo | Number of Participants With Treatment Success From Day 5 to Day 7 | Vomiting episodes ≥2 (per day) since Day 5 | 2 Participants |
| Placebo | Number of Participants With Treatment Success From Day 5 to Day 7 | No Anticholinergic agents | 25 Participants |
| Placebo | Number of Participants With Treatment Success From Day 5 to Day 7 | No Nasogastric Tube since Day 5 | 24 Participants |
Secondary
Number of Vomiting Episodes Per Day at Day1, Day 2 and Day 14
The mean number of vomiting episodes per a 24 hour period is presented for Day 1, Day 7 and Day 14.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Octreotide | Number of Vomiting Episodes Per Day at Day1, Day 2 and Day 14 | Day 1 | 1.2 Vomiting episodes | Standard Deviation 2.14 |
| Octreotide | 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 |
| Octreotide | 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 |
| Placebo | Number of Vomiting Episodes Per Day at Day1, Day 2 and Day 14 | Day 1 | 0.6 Vomiting episodes | Standard Deviation 1.85 |
| Placebo | Number of Vomiting Episodes Per Day at Day1, Day 2 and Day 14 | Day 7 (n=31,31) | 0.4 Vomiting episodes | Standard Deviation 0.84 |
| Placebo | Number of Vomiting Episodes Per Day at Day1, Day 2 and Day 14 | Day 14 (n=28,27) | 0.5 Vomiting episodes | Standard Deviation 2.12 |
Secondary
Participant's Quality of Life Using the Edmonton Scale
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Octreotide | Participant's Quality of Life Using the Edmonton Scale | Day 1 (n=30,29) | 4.12 Scores on a scale | Standard Deviation 1.174 |
| Octreotide | Participant's Quality of Life Using the Edmonton Scale | Day 7 (n=24,26) | 4.23 Scores on a scale | Standard Deviation 1.695 |
| Octreotide | Participant's Quality of Life Using the Edmonton Scale | Day 14 (n=20,14) | 4.30 Scores on a scale | Standard Deviation 1.652 |
| Octreotide | Participant's Quality of Life Using the Edmonton Scale | Month 1 (n=11,13) | 4.18 Scores on a scale | Standard Deviation 1.905 |
| Octreotide | Participant's Quality of Life Using the Edmonton Scale | Month 2 (n=7,4) | 3.46 Scores on a scale | Standard Deviation 2.339 |
| Octreotide | Participant's Quality of Life Using the Edmonton Scale | Month 3 (n=2,2) | 0.05 Scores on a scale | Standard Deviation 0.071 |
| Placebo | Participant's Quality of Life Using the Edmonton Scale | Month 2 (n=7,4) | 3.23 Scores on a scale | Standard Deviation 1.609 |
| Placebo | Participant's Quality of Life Using the Edmonton Scale | Day 1 (n=30,29) | 4.12 Scores on a scale | Standard Deviation 1.36 |
| Placebo | Participant's Quality of Life Using the Edmonton Scale | Month 1 (n=11,13) | 4.49 Scores on a scale | Standard Deviation 1.82 |
| Placebo | Participant's Quality of Life Using the Edmonton Scale | Day 7 (n=24,26) | 3.37 Scores on a scale | Standard Deviation 1.247 |
| Placebo | Participant's Quality of Life Using the Edmonton Scale | Month 3 (n=2,2) | 1.60 Scores on a scale | Standard Deviation 0.283 |
| Placebo | Participant's Quality of Life Using the Edmonton Scale | Day 14 (n=20,14) | 3.85 Scores on a scale | Standard Deviation 1.86 |