Trial · NCT00332696

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

NCT00332696, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2011-06-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Octreotide Compared to Placebo in Patients With Inoperable Bowel Obstruction Due to Peritoneal Carcinomatosis. Trials, record NCT00332696. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00332696

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Octreotide Compared to Placebo in Patients With Inoperable Bowel Obstruction Due to Peritoneal Carcinomatosis
NCT number: NCT00332696
Status: Completed
Phases: Phase 2
Enrollment: 64 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Peritoneal Neoplasms, Intestinal Obstruction, Carcinomatosis
Interventions: Octreotide LAR, Octreotide (Immediate release), methylprednisolone, Placebo
First posted: 2006-06-02
Last updated: 2011-09-23
Results first posted: 2011-06-15
Limitations and caveats: Study was terminated prematurely due to low enrollment

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Treatment Success From Day 10 to Day 13	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	Number of Participants With Treatment Success From Day 5 to Day 7	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).
Secondary	Number of Vomiting Episodes Per Day at Day1, Day 2 and Day 14	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.
Secondary	Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 1	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.
Secondary	Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 7	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.
Secondary	Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 14	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.
Secondary	Number of Participants With Relief From Obstruction at Day 7 and Day 14	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.
Secondary	Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 1	1 Month	Recurrence of bowel obstruction was confirmed by abdominal X-ray.
Secondary	Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 2	Month 2	Recurrence of bowel obstruction was confirmed by abdominal X-ray.
Secondary	Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 3	Month 3	Recurrence of bowel obstruction was confirmed by abdominal X-ray.

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Treatment Success From Day 10 to Day 13	Day 10 to Day 13	Intent-to-treat population consisted of all randomized participants who received at least one dose of study drug.	Participants	NUMBER
SECONDARY	Number of Participants With Treatment Success From Day 5 to Day 7	Day 5 to Day 7	Intent-to-treat population consisted of all randomized participants who received at least one dose of study drug.	Participants	NUMBER
SECONDARY	Number of Vomiting Episodes Per Day at Day1, Day 2 and Day 14	Day 1, Day 7 and Day 14	Intent-to-treat population consisted of all randomized participants who received study drug. n in each of the categories is the number of participants with data at the given time point.	Vomiting episodes	MEAN
SECONDARY	Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 1	Day 1	Intent-to-treat population consisted of all randomized participants who received at least one dose of study drug.	Participants	NUMBER
SECONDARY	Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 7	Day 7	Participants from the Intent-to-treat population consisting of all randomized participants who received study drug and for whom data was available at Day 7.	Participants	NUMBER
SECONDARY	Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 14	Day 14	Participants from the Intent-to-treat population consisting of all randomized participants who received study drug and for whom data was available at Day 14.	Participants	NUMBER
SECONDARY	Number of Participants With Relief From Obstruction at Day 7 and Day 14	Day 7 and Day 14	Intent-to-treat population consisted of all randomized participants who received at least one dose of study drug.	Participants	NUMBER
SECONDARY	Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 1	1 Month	Participants from the Intent-to-treat population (consisting of all randomized participants who received at least one dose of study drug) for whom data was available at Month 1.	Participants	NUMBER
SECONDARY	Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 2	Month 2	Participants from the Intent-to-treat population (consisting of all randomized participants who received at least one dose of study drug) for whom data was available at Month 2.	Participants	NUMBER
SECONDARY	Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 3	Month 3	Participants from the Intent-to-treat population (consisting of all randomized participants who received at least one dose of study drug) for whom data was available at Month 3.	Participants	NUMBER

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group94

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Participants With Treatment Success From Day 10 to Day 13	Octreotide	TREATMENT SUCCESS	12	Participants
Number of Participants With Treatment Success From Day 10 to Day 13	Placebo	TREATMENT SUCCESS	9	Participants
Number of Participants With Treatment Success From Day 10 to Day 13	Octreotide	Vomiting episodes <2 (per day)	19	Participants
Number of Participants With Treatment Success From Day 10 to Day 13	Placebo	Vomiting episodes <2 (per day)	13	Participants
Number of Participants With Treatment Success From Day 10 to Day 13	Octreotide	Vomiting episodes ≥2 (per day)	2	Participants
Number of Participants With Treatment Success From Day 10 to Day 13	Placebo	Vomiting episodes ≥2 (per day)	2	Participants
Number of Participants With Treatment Success From Day 10 to Day 13	Octreotide	No Nasogastric Tube since Day 10	14	Participants
Number of Participants With Treatment Success From Day 10 to Day 13	Placebo	No Nasogastric Tube since Day 10	13	Participants
Number of Participants With Treatment Success From Day 10 to Day 13	Octreotide	Nasogastric Tube used since Day 10	7	Participants
Number of Participants With Treatment Success From Day 10 to Day 13	Placebo	Nasogastric Tube used since Day 10	2	Participants

1 to 10 of 94Source ClinicalTrials.gov

See all 94 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Octreotide	32
Overall Study	STARTED	Placebo	32
Overall Study	Completed Day 14 Visit	Octreotide	21
Overall Study	Completed Day 14 Visit	Placebo	15
Overall Study	COMPLETED	Octreotide	2
Overall Study	COMPLETED	Placebo	2
Overall Study	NOT COMPLETED	Octreotide	30
Overall Study	NOT COMPLETED	Placebo	30

Source ClinicalTrials.gov

Adverse events150

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anaemia	Blood and lymphatic system disorders	Octreotide	2	32
other	Anaemia	Blood and lymphatic system disorders	Placebo	1	32
other	Thrombocytopenia	Blood and lymphatic system disorders	Octreotide	1	32
other	Thrombocytopenia	Blood and lymphatic system disorders	Placebo	2	32
other	Cardiogenic shock	Cardiac disorders	Octreotide	0	32
other	Cardiogenic shock	Cardiac disorders	Placebo	2	32
other	Abdominal pain	Gastrointestinal disorders	Octreotide	7	32
other	Abdominal pain	Gastrointestinal disorders	Placebo	4	32
other	Diarrhoea	Gastrointestinal disorders	Octreotide	5	32
other	Diarrhoea	Gastrointestinal disorders	Placebo	3	32

1 to 10 of 150Source ClinicalTrials.gov

See all 150 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Octreotide
Total, all-cause mortality	Placebo
Total, other adverse events	Octreotide	24	32
Total, other adverse events	Placebo	19	32
Total, serious adverse events	Octreotide	6	32
Total, serious adverse events	Placebo	6	32

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Octreotide vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00332696

GET https://conductscience.org/api/trials/v1/NCT00332696/results?page=2

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