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

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00703534
• Collaborator: (none)
• Enrollment: 478
• Locations: 84
• Arms: 2
• Duration (Months): 8
• Patients Per Site: 5.7
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

This research study is being done to gather information about how to do further clinical studies using AZD3355 as an add-on treatment to proton pump inhibitors (PPI).

Condition or Disease	Intervention/Treatment	Phase
GERD; Acid Reflux Disease; Heartburn; Regurgitation	Drug: AZD3355; Drug: Placebo; Drug: Gelusil®	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 478 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Official Title: Validation of Patient-reported Outcomes Measures for the Assessment of GERD Symptoms and Their Subsequent Impact on Patients With Partial Response to Proton Pump Inhibitor (PPI) Treatment in a Two Part Multi-center Phase IIa Study Including a Four Week Randomised, Double-blind, Placebo-controlled, Parallel-group Treatment Period
• Study Start Date: May 1, 2008
• Actual Primary Completion Date: Jan 1, 2009
• Actual Study Completion Date: Jan 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AZD3355	Drug: AZD3355; Immediate Release capsule administered as a single dose, 65mg, twice daily for 4 weeks; Other Names: Lesogaberan ; Drug: Gelusil®; Chewable tablets taken as needed
Placebo Comparator: Placebo	Drug: Placebo; capsule. administered as a single dose twice daily for 4 weeks; Drug: Gelusil®; Chewable tablets taken as needed

Outcome Measures

Primary Outcome Measures

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

   Symptom intensity rated on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subject able to read and write US english and able to use electronic devices

• Subjects who have experienced GERD symptoms for at least six months

• Subjects currently taking a prescription or over-the-counter PPI medications for GERD

• Body Mass Index (BMI) 18.5-35.0, inclusive

Exclusion Criteria:

• Subjects that have not experienced any GERD symptoms improvement at all after PPI treatment

• Subjects who have any of the following conditions or diseases- Heart disease, Angina, Seizure disorders such as epilepsy, Congestive Heart Failure (CHF), Liver disease such as Cirrhosis or Hepatitis, Kidney disease, Lung disease or lung cancer, Cancer

• Prior surgery of the upper Gastrointestinal (GI) tract

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Athens	Alabama	United States
2	Research Site	Tucson	Arizona	United States
3	Research Site	Little Rock	Arkansas	United States
4	Research Site	Sherwood	Arkansas	United States
5	Research Site	Anaheim	California	United States
6	Research Site	Los Angeles	California	United States
7	Research Site	Monterey	California	United States
8	Research Site	Murrieta	California	United States
9	Research Site	Orange	California	United States
10	Research Site	San Diego	California	United States
11	Research Site	Torrance	California	United States
12	Research Site	Colorado Springs	Colorado	United States
13	Research Site	Pueblo	Colorado	United States
14	Research Site	Boynton Beach	Florida	United States
15	Research Site	Deland	Florida	United States
16	Research Site	Hialeah	Florida	United States
17	Research Site	Jacksonville	Florida	United States
18	Research Site	Jupiter	Florida	United States
19	Research Site	Lauderdale Lakes	Florida	United States
20	Research Site	Miami	Florida	United States
21	Research Site	New Smyrna Beach	Florida	United States
22	Research Site	Pembroke Pines	Florida	United States
23	Research Site	Port Orange	Florida	United States
24	Research Site	Tampa	Florida	United States
25	Research Site	Zephyrhills	Florida	United States
26	Research Site	Atlanta	Georgia	United States
27	Research Site	Stockbridge	Georgia	United States
28	Research Site	Chicago	Illinois	United States
29	Research Site	Arkansas City	Kansas	United States
30	Research Site	Newton	Kansas	United States
31	Research Site	Wichita	Kansas	United States
32	Research Site	Madisonville	Kentucky	United States
33	Research Site	Monroe	Louisiana	United States
34	Research Site	Shreveport	Louisiana	United States
35	Research Site	Baltimore	Maryland	United States
36	Research Site	Chevy Chase	Maryland	United States
37	Research Site	Columbia	Maryland	United States
38	Research Site	Elkridge	Maryland	United States
39	Research Site	Hollywood	Maryland	United States
40	Research Site	Brockton	Massachusetts	United States
41	Research Site	Chesterfield	Michigan	United States
42	Research Site	Biloxi	Mississippi	United States
43	Research Site	Jackson	Mississippi	United States
44	Research Site	Jefferson City	Missouri	United States
45	Research Site	Las Vegas	Nevada	United States
46	Research Site	Great Neck	New York	United States
47	Research Site	New York	New York	United States
48	Research Site	Asheville	North Carolina	United States
49	Research Site	Elkin	North Carolina	United States
50	Research Site	Fayetteville	North Carolina	United States
51	Research Site	Greensboro	North Carolina	United States
52	Research Site	Harrisburg	North Carolina	United States
53	Research Site	Morgantown	North Carolina	United States
54	Research Site	Wilmington	North Carolina	United States
55	Research Site	Winston-salem	North Carolina	United States
56	Research Site	Akron	Ohio	United States
57	Research Site	Canton	Ohio	United States
58	Research Site	Norman	Oklahoma	United States
59	Research Site	Oklahoma City	Oklahoma	United States
60	Research Site	Portland	Oregon	United States
61	Research Site	Duncansville	Pennsylvania	United States
62	Research Site	Harrisburg	Pennsylvania	United States
63	Research Site	Sayre	Pennsylvania	United States
64	Research Site	Cranston	Rhode Island	United States
65	Research Site	Anderson	South Carolina	United States
66	Research Site	Simpsonville	South Carolina	United States
67	Research Site	Chattanooga	Tennessee	United States
68	Research Site	Germantown	Tennessee	United States
69	Research Site	Jackson	Tennessee	United States
70	Research Site	Johnson City	Tennessee	United States
71	Research Site	Knoxville	Tennessee	United States
72	Research Site	Nashville	Tennessee	United States
73	Research Site	Houston	Texas	United States
74	Research Site	San Antonio	Texas	United States
75	Research Site	Ogden	Utah	United States
76	Research Site	Charlottesville	Virginia	United States
77	Research Site	Chesapeake	Virginia	United States
78	Research Site	Christiansburg	Virginia	United States
79	Research Site	Newport News	Virginia	United States
80	Research Site	Norfolk	Virginia	United States
81	Research Site	Richmond	Virginia	United States
82	Research Site	Milwaukee	Wisconsin	United States
83	Research Site	Waukesha	Wisconsin	United States
84	Research Site	West End	Wisconsin	United States

Sponsors and Collaborators

• AstraZeneca

Investigators

• Study Director: Debra Silberg, MD, AstraZeneca
• Principal Investigator: Nimish Vakil, MD, Aurora Health Center/Waukesha

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00703534
• Other Study ID Numbers: D9120C00027
• First Posted: Jun 23, 2008
• Last Update Posted: Jun 20, 2011
• Last Verified: May 1, 2011

• Keywords provided by , ,: GERD; Acid Reflux; Heartburn; Regurgitation; non-acid reflux; PRO measures
• Additional relevant MeSH terms: Gastroesophageal Reflux; Heartburn; Lesogaberan

Study Results

Participant Flow

Arm/Group Title	AZD3355	Placebo
Arm/Group Description	AZD3355 capsules 65 mg twice daily, Gelusil tablets as rescue medication if needed	Placebo capsules twice daily, Gelusil tablets as rescue medication if needed
Period Title: Overall Study
STARTED	235	243
COMPLETED	205	218
NOT COMPLETED	30	25

Baseline Characteristics

Arm/Group Title	AZD3355	Placebo	Total
Arm/Group Description	AZD3355 capsules 65 mg twice daily, Gelusil tablets as rescue medication if needed	Placebo capsules twice daily, Gelusil tablets as rescue medication if needed	Total of all reporting groups
Overall Participants	235	243	478
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	49.7 (10.09)	47.8 (11.5)	48.7 (11.2)
Sex: Female, Male (Count of Participants)
Female	145 61.7%	135 55.6%	280 58.6%
Male	90 38.3%	108 44.4%	198 41.4%

Outcome Measures

1. Primary Outcome

Title	Symptom Intensity Rated by Participants Twice Daily Using an Electronic Reflux Symptom Questionnaire Diary
Description	Symptom intensity rated on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe)
Time Frame	Run-in period of 8-12 days and treatment period of 26-30 days

Outcome Measure Data

Analysis Population Description

None of the analyses addressing the objectives related to validation of the patient reported outcome measures were made per treatment arm and can therefore not be reported in this format.

Arm/Group Title	AZD3355	Placebo
Arm/Group Description	AZD3355 capsules 65 mg twice daily, Gelusil tablets as rescue medication if needed	Placebo capsules twice daily, Gelusil tablets as rescue medication if needed
Measure Participants	0	0

Adverse Events

Arm/Group Title	AZD3355		Placebo
Arm/Group Description	AZD3355 capsules 65 mg twice daily, Gelusil tablets as rescue medication if needed		Placebo capsules twice daily, Gelusil tablets as rescue medication if needed
All Cause Mortality
	AZD3355		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	AZD3355		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/ (NaN)		2/ (NaN)
Cardiac disorders
Myocardial Infarction	0/235 (0%)		1/243 (0.4%)
Injury, poisoning and procedural complications
Operative Hemorrhage	1/235 (0.4%)		0/243 (0%)
Psychiatric disorders
Suicide Attemp	0/235 (0%)		1/243 (0.4%)
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema	0/235 (0%)		1/243 (0.4%)
Respiratory Failure	0/235 (0%)		1/243 (0.4%)
Other (Not Including Serious) Adverse Events
	AZD3355		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	18/ (NaN)		7/ (NaN)
Gastrointestinal disorders
Diarrhoea	18/235 (7.7%)		7/243 (2.9%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

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.