Back to resultsOctreotide Compared to Placebo in Patients With Inoperable Bowel Obstruction Due to Peritoneal Carcinomatosis
Primary Purpose
Peritoneal Neoplasms, Intestinal Obstruction, Carcinomatosis
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Octreotide LAR
Octreotide (Immediate release)
methylprednisolone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Peritoneal Neoplasms focused on measuring bowel obstruction,, peritoneal carcinomatosis, Octreotide, inoperable
Eligibility Criteria
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 : Anticholinergics such as scopolamine Other somatostatin analogues Other protocol-defined inclusion/exclusion criteria may apply
Sites / Locations
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Octreotide
Placebo
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
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.
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.
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.
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.
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.
Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 1
Recurrence of bowel obstruction was confirmed by abdominal X-ray.
Number of Participants With Recurrence of an Episode of Bowel Obstruction at 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
Recurrence of bowel obstruction was confirmed by abdominal X-ray.
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.
Full Information
NCT ID
NCT00332696
First Posted
June 1, 2006
Last Updated
September 20, 2011
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00332696
Brief Title
Octreotide Compared to Placebo in Patients With Inoperable Bowel Obstruction Due to Peritoneal Carcinomatosis
Official Title
Evaluation of the Effect of Octreotide Compared to Placebo in Patients With Inoperable Bowel Obstruction Due to Peritoneal Carcinomatosis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritoneal Neoplasms, Intestinal Obstruction, Carcinomatosis
Keywords
bowel obstruction,, peritoneal carcinomatosis, Octreotide, inoperable
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Octreotide
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Octreotide LAR
Other Intervention Name(s)
Sandostatin® LAR
Intervention Description
Octreotide long-acting release (LAR) 30 mg intramuscular injection.
Intervention Type
Drug
Intervention Name(s)
Octreotide (Immediate release)
Other Intervention Name(s)
Sandostatin®
Intervention Description
Immediate-release Octreotide supplied in 100 µg/mL ampules.
Intervention Type
Drug
Intervention Name(s)
methylprednisolone
Intervention Description
methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Physiologic saline solution
Primary Outcome Measure Information:
Title
Number of Participants With Treatment Success From Day 10 to Day 13
Description
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
Secondary Outcome Measure Information:
Title
Number of Participants With Treatment Success From Day 5 to Day 7
Description
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
Title
Number of Vomiting Episodes Per Day at Day1, Day 2 and Day 14
Description
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
Title
Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 1
Description
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
Title
Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 7
Description
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
Title
Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 14
Description
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
Title
Number of Participants With Relief From Obstruction at Day 7 and Day 14
Description
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
Title
Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 1
Description
Recurrence of bowel obstruction was confirmed by abdominal X-ray.
Time Frame
1 Month
Title
Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 2
Description
Recurrence of bowel obstruction was confirmed by abdominal X-ray.
Time Frame
Month 2
Title
Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 3
Description
Recurrence of bowel obstruction was confirmed by abdominal X-ray.
Time Frame
Month 3
Title
Participant's Quality of Life Using the Edmonton Scale
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 :
Anticholinergics such as scopolamine
Other somatostatin analogues
Other protocol-defined inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Creteil
Country
France
12. IPD Sharing Statement
Learn more about this trial
Octreotide Compared to Placebo in Patients With Inoperable Bowel Obstruction Due to Peritoneal Carcinomatosis
We'll reach out to this number within 24 hrs