Extended Safety Study of Montelukast in Infants and Young Children With Chronic Asthma

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00943397

First received: July 21, 2009

Last updated: May 18, 2010

Last verified: May 2010

History of Changes

Results First Received: July 27, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Asthma
Interventions:	Drug: montelukast sodium Drug: Comparator: Usual Care

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited at 27 sites in Africa, Europe, North America, and South America Therapy period: May 2001 to Mar 2003.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This was an open-label, controlled extended safety study. Patients were treated with either montelukast 4-mg oral granules or usual care. Patients who completed Protocol 176-01 had the option to enroll in this study. Additionally, patients with asthma who were 6 to 11 months of age and who had not participated in Protocol 176-01, could also enroll.

Reporting Groups

	Description
Usual Care	Usual care: defined as inhaled/nebulized cromolyn or inhaled nedocromil or inhaled/nebulized corticosteroids, according to the investigator’s usual clinical practice for 52 weeks
Montelukast	Montelukast 4-mg oral granules mixed with 1 tablespoon soft food once daily at bedtime for 52 weeks.

Participant Flow: Overall Study

	Usual Care	Montelukast
STARTED	32	158
COMPLETED	17 ^[1]	86 ^[2]
NOT COMPLETED	15	72
Adverse Event	0	6
Lost to Follow-up	0	4
Protocol Violation	2	5
Withdrawal by Subject	1	1
Site terminated and other	12	56

[1]	Site terminated - Merck administrative decision (11); Discontinued for other (1)
[2]	Site terminated - Merck administrative decision (52); Patient moved (1); Discontinued for other (3)

Baseline Characteristics

Show Baseline Characteristics

Outcome Measures

1. Primary:

Number of Clinical Adverse Experiences (CAEs) Reported by Patients With up to 52 Weeks of Treatment [ Time Frame: Up to 52 weeks of treatment ]

Show Outcome Measure 1

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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: Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire 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
No text entered.

Results Point of Contact:

Name/Title: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00943397 History of Changes
Other Study ID Numbers:	2009_619, MK0476-232
Study First Received:	July 21, 2009
Results First Received:	July 27, 2009
Last Updated:	May 18, 2010
Health Authority:	United States: Food and Drug Administration

To Top