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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT00332696

First received: June 1, 2006

Last updated: September 20, 2011

Last verified: September 2011

History of Changes

Results First Received: January 17, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Conditions:	Peritoneal Neoplasms Intestinal Obstruction Carcinomatosis
Interventions:	Drug: Octreotide LAR Drug: Octreotide (Immediate release) Drug: methylprednisolone Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

Description

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

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.

Participant Flow: Overall Study

	Octreotide	Placebo
STARTED	32	32
Completed Day 14 Visit	21 ^[1]	15
COMPLETED	2 ^[2]	2
NOT COMPLETED	30	30
Death	24	14
Insufficient therapeutic effect	4	11
Adverse Event	1	2
Condition does not justify treatment	0	2
Lost to Follow-up	0	1
Withdrawal by Subject	1	0

[1]	Primary Endpoint
[2]	Completed Month 3 Visit

Baseline Characteristics

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Reporting Groups

	Description
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	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.
Total	Total of all reporting groups

Baseline Measures

	Octreotide	Placebo	Total
Number of Participants [units: participants]	32	32	64
Age [units: years] Mean ± Standard Deviation	65.3 ± 9.57	63.1 ± 12.36	64.2 ± 11.02
Gender [units: participants]
Female	25	21	46
Male	7	11	18

Outcome Measures

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1. Primary:

Number of Participants With Treatment Success From Day 10 to Day 13 [ Time Frame: Day 10 to Day 13 ]

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2. Secondary:

Number of Participants With Treatment Success From Day 5 to Day 7 [ Time Frame: Day 5 to Day 7 ]

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3. Secondary:

Number of Vomiting Episodes Per Day at Day1, Day 2 and Day 14 [ Time Frame: Day 1, Day 7 and Day 14 ]

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4. Secondary:

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

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5. Secondary:

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

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6. Secondary:

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

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7. Secondary:

Number of Participants With Relief From Obstruction at Day 7 and Day 14 [ Time Frame: Day 7 and Day 14 ]

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8. Secondary:

Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 1 [ Time Frame: 1 Month ]

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9. Secondary:

Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 2 [ Time Frame: Month 2 ]

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10. Secondary:

Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 3 [ Time Frame: Month 3 ]

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11. Secondary:

Participant's Quality of Life Using the Edmonton Scale [ Time Frame: Day 1, Day 7, Day 14, Month 1, Month 2 and Month 3 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Disclosure Restriction Description: The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial; or of the trial results in their entirety.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study was terminated prematurely due to low enrollment

Results Point of Contact:

Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300

No publications provided

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT00332696 History of Changes
Other Study ID Numbers:	CSMS995AFR08
Study First Received:	June 1, 2006
Results First Received:	January 17, 2011
Last Updated:	September 20, 2011
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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