Clinical Trial: Octreotide Compared to Placebo in Patients With Inoperable Bowel Obstruction Due to Peritoneal Carcinomatosis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Evaluation of the Effect of Octreotide Compared to Placebo in Patients With Inoperable Bowel Obstruction Due to Peritoneal Carcinomatosis
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
Detailed Summary:
Sponsor: Novartis Pharmaceuticals
Current Primary Outcome: Number of Participants With Treatment Success From Day 10 to Day 13 [ Time Frame: 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.
Original Primary Outcome:
- Binary criterion, success or failure at D14 defined as follows
- Success: Relief of bowel obstruction symptoms defined by :
- Less than (exclusive) 2 vomiting episodes/day (mean of the four days from D10 to D13)
- And remove of NGT (since at least D10) (for patients included with NGT)
- And no start of treatment with anticholinergics such as scopolamine
- Failure :
- More than 2 (inclusive) vomiting episodes day (mean of the four days from D10 to D13)
- Or persistence of NGT after D9
- Or start of treatment with anticholinergics such as scopolamine before D14
- Or drop-out between D1 and D14 (inclusive) whatever the reason.
Current Secondary Outcome:
- Number of Participants With Treatment Success From Day 5 to Day 7 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Month 3 ]Recurrence of bowel obstruction was confirmed by abdominal X-ray.
- Participant's Quality of Life Using the Edmonton Scale [ Time Frame: 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.
Original Secondary Outcome:
- Secondary efficacy criteria: at D7 (success/failure), at M1, M2 and M3: recurrence of bowel obstruction (confirmed by imaging).
- Safety
Information By: Novartis
Dates:
Date Received: June 1, 2006
Date Started: September 2005
Date Completion:
Last Updated: September 20, 2011
Last Verified: September 2011