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Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

NCTNCT00332696 (opens ClinicalTrials.gov in a new tab)Other idCSMS995AFR08
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
64 participants (actual)
Sponsor
Novartis Pharmaceuticals · Industry
Design
Randomized · Double masking
Countries
1 country

France

Start
Sept 2005
Primary completion
Sept 2008
Completion
Sept 2008
First posted
2 Jun 2006 (estimated)
Last update posted
23 Sept 2011 (estimated)
Conditions
Peritoneal Neoplasms · Intestinal Obstruction · Carcinomatosis

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20052006200720082009
  1. Ph 2

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

    NCT00332696

    Sept 2005 to Sept 2008

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

  • Octreotide LARDrug
  • Octreotide (Immediate release)Drug
  • methylprednisoloneDrug
  • PlaceboDrug

Arms2

  • Experimental

    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 comparator

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of Participants With Treatment Success From Day 10 to Day 13

    Time frame · Day 10 to Day 13

    Registry 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.

Secondary outcomes(10)

  1. Number of Participants With Treatment Success From Day 5 to Day 7

    Time frame · Day 5 to Day 7

    Registry 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).

  2. Number of Vomiting Episodes Per Day at Day1, Day 2 and Day 14

    Time frame · Day 1, Day 7 and Day 14

    Registry description

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

  3. Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 1

    Time frame · Day 1

    Registry 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.

  4. Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 7

    Time frame · Day 7

    Registry 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.

  5. Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 14

    Time frame · Day 14

    Registry 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.

  6. Number of Participants With Relief From Obstruction at Day 7 and Day 14

    Time frame · Day 7 and Day 14

    Registry 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.

  7. Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 1

    Time frame · 1 Month

    Registry description

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

  8. Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 2

    Time frame · Month 2

    Registry description

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

  9. Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 3

    Time frame · Month 3

    Registry description

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

  10. Participant's Quality of Life Using the Edmonton Scale

    Time frame · Day 1, Day 7, Day 14, Month 1, Month 2 and Month 3

    Registry 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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Day 10 to Day 13

Number of Participants With Treatment Success From Day 10 to Day 13

GroupValue (Participants)
Octreotide12
Placebo9
Secondary and other outcome results(7)
Secondary outcomeNumber· Day 5 to Day 7

Number of Participants With Treatment Success From Day 5 to Day 7

GroupValue (Participants)
Octreotide22
Placebo20
Secondary outcomeMean· Day 1, Day 7 and Day 14

Number of Vomiting Episodes Per Day at Day1, Day 2 and Day 14

GroupValue (Vomiting episodes)Spread
Octreotide1.22.14
Placebo0.61.85
Secondary outcomeNumber· Day 1

Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 1

GroupValue (Participants)
Octreotide16
Placebo13
Secondary outcomeNumber· Day 7

Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 7

GroupValue (Participants)
Octreotide21
Placebo15
Secondary outcomeNumber· Day 14

Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 14

GroupValue (Participants)
Octreotide22
Placebo22
Secondary outcomeNumber· Day 7 and Day 14

Number of Participants With Relief From Obstruction at Day 7 and Day 14

GroupValue (Participants)
Octreotide9
Placebo15
Secondary outcomeNumber· 1 Month

Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 1

GroupValue (Participants)
Octreotide1
Placebo2

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
OctreotideParticipants 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.–6 / 3224 / 32
PlaceboParticipants 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.–6 / 3219 / 32

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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/exclusion criteria may apply

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