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Completed

NCT Number: NCT00332696

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

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

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Key information

Conditions

Peritoneal Neoplasms Abdominal Neoplasms Carcinoma Carcinomatosis Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Intestinal Diseases Intestinal Obstruction Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Peritoneal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site

Créteil, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Octreotide LAR

Drug

Octreotide long-acting release (LAR) 30 mg intramuscular injection.

Other names: Sandostatin® LAR

Octreotide (Immediate release)

Drug

Immediate-release Octreotide supplied in 100 µg/mL ampules.

Other names: Sandostatin®

methylprednisolone

Drug

methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections).

Placebo

Drug

Physiologic saline solution

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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.

  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

    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

    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

    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

    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

    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

    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

    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

    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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

Evaluation of the Effect of Octreotide Compared to Placebo in Patients With Inoperable Bowel Obstruction Due to Peritoneal Carcinomatosis

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Jun 2, 2006
Registry last updated
Sep 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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