Phase 2
N=64
Octreotide Compared to Placebo in Patients With Inoperable Bowel Obstruction Due to Peritoneal Carcinomatosis
Peritoneal Neoplasms · Intestinal Obstruction · Carcinomatosis
Bottom Line
View on ClinicalTrials.gov: NCT00332696 ↗Enrolled (actual)
64
Serious AEs
18.8%
Results posted
Jun 2011
Primary outcome: Primary: Number of Participants With Treatment Success From Day 10 to Day 13 — 12; 9; 19; 13 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Octreotide LAR (Drug); Octreotide (Immediate release) (Drug); methylprednisolone (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Sep 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Success From Day 10 to Day 13 |
12; 9; 19; 13; 2; 2 | — |
| SECONDARY Number of Participants With Treatment Success From Day 5 to Day 7 |
22; 20; 28; 25; 1; 2 | — |
| SECONDARY Number of Vomiting Episodes Per Day at Day1, Day 2 and Day 14 |
1.2; 0.6; 0.3; 0.4; 0.3; 0.5 | — |
| SECONDARY Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 1 |
16; 13; 1; 2; 7; 9 | — |
| SECONDARY Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 7 |
21; 15; 2; 9; 5; 6 | — |
| SECONDARY Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 14 |
22; 22; 2; 3; 2; 1 | — |
| SECONDARY Number of Participants With Relief From Obstruction at Day 7 and Day 14 |
9; 15; 20; 12; 11; 10 | — |
| SECONDARY Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 1 |
1; 2; 13; 13 | — |
| SECONDARY Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 2 |
2; 2; 6; 5 | — |
| SECONDARY Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 3 |
0; 0; 3; 2 | — |
| SECONDARY Participant's Quality of Life Using the Edmonton Scale |
4.12; 4.12; 4.23; 3.37; 4.30; 3.85 | — |
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
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
Data sourced from ClinicalTrials.gov (NCT00332696). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.