Clinical trial · Interventional
Octreotide Compared to Placebo in Patients With Inoperable Bowel Obstruction Due to Peritoneal Carcinomatosis
Evaluation of the Effect of Octreotide Compared to Placebo in Patients With Inoperable Bowel Obstruction Due to Peritoneal Carcinomatosis
NCT00332696CI-TRIAL-00005531completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (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
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinomatosis | Carcinomatosis | ONTOLOGY_EXACT | 0.98 |
| Intestinal Obstruction | — | UNRESOLVED | — |
| Peritoneal Neoplasms | Peritoneal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| methylprednisolone | Drug | — | UNRESOLVED |
| Octreotide (Immediate release) | Drug | — | UNRESOLVED |
| Octreotide LAR | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Octreotide
- 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.
- interventionNames
- Drug: Octreotide LAR
- Drug: Octreotide (Immediate release)
- Drug: methylprednisolone
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.