Study to Evaluate the Efficacy and Safety of Sandostatin LAR at High Dose or in Combination Either With GH-receptor Antagonist or Dopamine-agonist in Acromegalic Patients (HOSCAR)

This study has been completed.

Sponsor:

Information provided by:

Novartis

ClinicalTrials.gov Identifier:

NCT01278342

First received: January 14, 2011

Last updated: April 20, 2011

Last verified: April 2011

History of Changes

Results First Received: January 22, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Acromegaly
Interventions:	Drug: Sandostatin LAR Drug: pegvisomant Drug: cabergoline

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

Sandostatin LAR High Dose Alone

All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with controlled GH and IGF-I after 3 months of Sandostatin LAR monotherapy continued to receive Sandostatin LAR 40 mg i.m. every 28 days for an additional 4 months.

Sandostatin LAR High Dose + Pegvisomat

All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Pegvisomant 70 mg subcutaneously (s.c.) for a further 4 months.

Sandostatin LAR High Dose + Cabergoline

All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Cabergoline for a further 4 months, with Cabergoline doses as follows:

1st week: 0.25 mg twice a week (0.50 mg/week)
2nd week: 0.50 mg/week twice a week (1 mg/week)
3rd week: 0.50 mg four times a week (2 mg/week)
4th week: 0.50 mg daily (3.5 mg/week) Subsequent 3 months: 0.50 mg daily (3.5 mg/week)

Participant Flow: Overall Study

	Sandostatin LAR High Dose Alone	Sandostatin LAR High Dose + Pegvisomat	Sandostatin LAR High Dose + Cabergoline
STARTED	7	31	32
COMPLETED	3	30	32
NOT COMPLETED	4	1	0
Physician Decision	0	1	0
Lost to Follow-up	1	0	0
Administrative problems	2	0	0
Other	1	0	0

Baseline Characteristics

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Reporting Groups

	Description
Sandostatin LAR High Dose Alone	All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with controlled GH and IGF-I after 3 months of Sandostatin LAR monotherapy continued to receive Sandostatin LAR 40 mg i.m. every 28 days for an additional 4 months.
Sandostatin LAR High Dose + Pegvisomat	All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Pegvisomant 70 mg subcutaneously (s.c.) for a further 4 months.
Sandostatin LAR High Dose + Cabergoline	All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Cabergoline for a further 4 months, with Cabergoline doses as follows: 1st week: 0.25 mg twice a week (0.50 mg/week) 2nd week: 0.50 mg/week twice a week (1 mg/week) 3rd week: 0.50 mg four times a week (2 mg/week) 4th week: 0.50 mg daily (3.5 mg/week) Subsequent 3 months: 0.50 mg daily (3.5 mg/week)
Total	Total of all reporting groups

Baseline Measures

	Sandostatin LAR High Dose Alone	Sandostatin LAR High Dose + Pegvisomat	Sandostatin LAR High Dose + Cabergoline	Total
Number of Participants [units: participants]	7	31	32	70
Age [units: years] Mean ± Standard Deviation	57.9 ± 7.71	44.6 ± 10.54	49.3 ± 10.50	48.1 ± 10.90
Gender [units: participants]
Female	3	17	18	38
Male	4	14	14	32

Outcome Measures

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1. Primary:

The Percentage of Participants With Complete Response (CR) at 8 Months [ Time Frame: From Baseline to 8 months ]

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2. Secondary:

The Percentage of Participants With Complete Response (CR) At 3 Months [ Time Frame: From Baseline to 3 months ]

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3. Secondary:

The Percentage of Participants With Partial Response (PR) at 8 Months [ Time Frame: From Baseline to 8 months ]

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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: 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.

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
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Results Point of Contact:

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

No publications provided

Responsible Party:	External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01278342 History of Changes
Other Study ID Numbers:	CSMS995BIC03, 2005-005852-42
Study First Received:	January 14, 2011
Results First Received:	January 22, 2011
Last Updated:	April 20, 2011
Health Authority:	France: National Consultative Ethics Committee for Health and Life Sciences Italy: National Monitoring Centre for Clinical Trials - Ministry of Health Portugal: Health Ethic Committee Switzerland: Swissmedic Poland: Ministry of Health

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