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Symptom Improvements in Gastroesophageal Reflux Disease (GERD) Patients

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ClinicalTrials.gov Identifier: NCT00394472
Recruitment Status : Completed
First Posted : November 1, 2006
Results First Posted : March 18, 2013
Last Update Posted : March 18, 2013
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition Gastroesophageal Reflux Disease (GERD)
Intervention Drug: AZD3355
Enrollment 244
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AZD3355 Placebo
Hide Arm/Group Description AZD3355 capsules 65 mg bid Placebo capsules bid
Period Title: Overall Study
Started 122 122
Completed 113 111
Not Completed 9 11
Reason Not Completed
Protocol Violation             1             3
incorrect enrolment             4             2
Adverse Event             4             2
Withdrawal by Subject             0             2
Physician Decision             0             1
Lost to Follow-up             0             1
Arm/Group Title AZD3355 Placebo Total
Hide Arm/Group Description AZD3355 capsules 65 mg bid Placebo capsules bid Total of all reporting groups
Overall Number of Baseline Participants 122 122 244
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 122 participants 122 participants 244 participants
51.1  (11.9) 48.7  (12.6) 49.9  (12.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 122 participants 122 participants 244 participants
Female
51
  41.8%
31
  25.4%
82
  33.6%
Male
71
  58.2%
91
  74.6%
162
  66.4%
1.Primary Outcome
Title Number of Participants With at Most One Day With Not More Than Mild Intensity of the Symptoms ‘a Burning Feeling Behind the Breastbone’ and ‘Unpleasant Movement of Material Upwards From the Stomach’ During the Last Seven Days of Treatment
Hide Description Symptom intensity rated by participants twice daily on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe) using an electronic Reflux Disease Questionnaire (RDQ) diary
Time Frame Twice daily during the last seven days on treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AZD3355 Placebo
Hide Arm/Group Description:
AZD3355 capsules 65 mg bid
Placebo capsules bid
Overall Number of Participants Analyzed 114 118
Measure Type: Number
Unit of Measure: Participants
17 8
2.Secondary Outcome
Title Plasma Concentration (µmol/L) of AZD3355 Analysed From Blood Sample Taken in the Interval One to Two Hours After the First Intake of AZD3355 65 mg Capsule
Hide Description [Not Specified]
Time Frame An interval of one to two hours after the first intake of AZD3355 65 mg capsule
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AZD3355 Placebo
Hide Arm/Group Description:
AZD3355 capsules 65 mg bid
Placebo capsules bid
Overall Number of Participants Analyzed 122 0
Mean (Standard Deviation)
Unit of Measure: μmol/L
0.96  (0.74)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AZD3355 Placebo
Hide Arm/Group Description AZD3355 capsules 65 mg bid Placebo capsules bid
All-Cause Mortality
AZD3355 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
AZD3355 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   2   0 
Infections and infestations     
Appendicitis * 1  1/122 (0.82%)  0/122 (0.00%) 
Vascular disorders     
Hypertension * 1  1/122 (0.82%)  0/122 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AZD3355 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   28   19 
Gastrointestinal disorders     
DIARRHOEA * 1  13/122 (10.66%)  4/122 (3.28%) 
NAUSEA * 1  9/122 (7.38%)  4/122 (3.28%) 
General disorders     
FATIGUE * 1  7/122 (5.74%)  7/122 (5.74%) 
Nervous system disorders     
PARAESTHESIA * 1  10/122 (8.20%)  6/122 (4.92%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.0
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.
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 before publ.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gerard Lynch
Organization: AstraZeneca
EMail: aztrial_results_posting@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00394472     History of Changes
Other Study ID Numbers: D9120C00011
EUDRACT No 2006-003541-16
First Submitted: October 31, 2006
First Posted: November 1, 2006
Results First Submitted: August 11, 2011
Results First Posted: March 18, 2013
Last Update Posted: March 18, 2013