Validation of Patient-reported Outcomes Measures for the Assessment of Gastroesophageal Reflux Disease (GERD) Symptoms (C27)

This study has been completed.

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00703534

First received: June 19, 2008

Last updated: May 20, 2011

Last verified: May 2011

History of Changes

Results First Received: February 4, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator)
Conditions:	GERD Acid Reflux Disease Heartburn Regurgitation
Interventions:	Drug: AZD3355 Drug: Placebo Drug: Gelusil®

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
AZD3355	AZD3355 capsules 65 mg twice daily, Gelusil tablets as rescue medication if needed
Placebo	Placebo capsules twice daily, Gelusil tablets as rescue medication if needed

Participant Flow: Overall Study

	AZD3355	Placebo
STARTED	235	243
COMPLETED	205	218
NOT COMPLETED	30	25
Adverse Event	14	3
Withdrawal by Subject	8	7
Incorrect Enrollment	6	6
Lost to Follow-up	1	4
Severe Non Compliance	1	5

Baseline Characteristics

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Reporting Groups

	Description
AZD3355	AZD3355 capsules 65 mg twice daily, Gelusil tablets as rescue medication if needed
Placebo	Placebo capsules twice daily, Gelusil tablets as rescue medication if needed
Total	Total of all reporting groups

Baseline Measures

	AZD3355	Placebo	Total
Number of Participants [units: participants]	235	243	478
Age [units: Years] Mean ± Standard Deviation	49.7 ± 10.09	47.8 ± 11.5	48.7 ± 11.2
Gender [units: Participants]
Female	145	135	280
Male	90	108	198

Outcome Measures

1. Primary:

Symptom Intensity Rated by Participants Twice Daily Using an Electronic Reflux Symptom Questionnaire Diary [ Time Frame: Run-in period of 8-12 days and treatment period of 26-30 days ]

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Serious Adverse Events

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Additional Description	No text entered.

Reporting Groups

	Description
AZD3355	AZD3355 capsules 65 mg twice daily, Gelusil tablets as rescue medication if needed
Placebo	Placebo capsules twice daily, Gelusil tablets as rescue medication if needed

Serious Adverse Events

	AZD3355	Placebo
Total, serious adverse events
# participants affected	1	2
Cardiac disorders
Myocardial Infarction ^{* 1}
# participants affected / at risk	0/235 (0.00%)	1/243 (0.41%)
Injury, poisoning and procedural complications
Operative Hemorrhage ^{* 1}
# participants affected / at risk	1/235 (0.43%)	0/243 (0.00%)
Psychiatric disorders
Suicide Attemp ^{* 1}
# participants affected / at risk	0/235 (0.00%)	1/243 (0.41%)
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema ^{* 1}
# participants affected / at risk	0/235 (0.00%)	1/243 (0.41%)
Respiratory Failure ^{* 1}
# participants affected / at risk	0/235 (0.00%)	1/243 (0.41%)

*	Events were collected by non-systematic assessment
1	Term from vocabulary, MedDRA 10.0

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: AZ shall have 30 days from the proposed final manuscript for any disclosure to review it and may within such time require that submission for publication/disclosure be delayed in order for AZ to file patent applications. If study site/investigator requests permission to publish data(incl oral presentations) it is to be agreed with AZ prior to publ.

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: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com

No publications provided

Responsible Party:	Debra Silberg, MD, Director of Clinical Research, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00703534 History of Changes
Other Study ID Numbers:	D9120C00027
Study First Received:	June 19, 2008
Results First Received:	February 4, 2011
Last Updated:	May 20, 2011
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board

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