Trial Outcomes & Findings for Role of Pain Modulation in GERD Patients Who Failed Standard Dose PPI (NCT NCT00539240)
NCT ID: NCT00539240
Last Updated: 2014-08-18
Results Overview
the number of days with Symptom Intensity Score \< 3 (better) for daytime heartburn during week 6 as compared to baseline
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
236 participants
Primary outcome timeframe
Symptom control after 6 weeks of treatment
Results posted on
2014-08-18
Participant Flow
Recruitment from GI clinic in VA medical center between 4/19/2006 and 3/31/2010
Eligibility screening occurred prior to randomization. Of 236 patients enrolled, 68 patients were not randomized due to abnormal endoscopy (14 patients), asymptomatic during run-in period (2 patients), lost to follow-up (11 patients), consent withdrawal, protocol deviation and screen failure (32 patients) and other causes (9 patients).
Participant milestones
| Measure |
Arm 1
AciPhex 20 mg BID and once daily placebo
Rabeprazole 20mg, placebo dinner and bedtime: Breakfast study medication - Rabeprazole 20mg, matching placebo at dinner , Placebo for tricyclic antidepressant at bedtime
|
Arm 2
AcipHex 20 mg once daily and BID placebo
Rabeprazole 20 mg two times, Placebo at bedtime: Breakfast \& Dinner study medication - Rabeprazole, placebo for tricyclic antidepressant at bedtime
|
Arm 3
AcipHex 20 mg once daily, placebo once daily and nortriptyline once daily
Rabeprazole 20mg,placebo dinner ,Low dose Tricyclic Antidepressant: Rabeprazole (Breakfast) study medication, dinner placebo medication, tricyclic antidepressant at bedtime
|
|---|---|---|---|
|
Overall Study
STARTED
|
59
|
55
|
54
|
|
Overall Study
COMPLETED
|
53
|
48
|
39
|
|
Overall Study
NOT COMPLETED
|
6
|
7
|
15
|
Reasons for withdrawal
| Measure |
Arm 1
AciPhex 20 mg BID and once daily placebo
Rabeprazole 20mg, placebo dinner and bedtime: Breakfast study medication - Rabeprazole 20mg, matching placebo at dinner , Placebo for tricyclic antidepressant at bedtime
|
Arm 2
AcipHex 20 mg once daily and BID placebo
Rabeprazole 20 mg two times, Placebo at bedtime: Breakfast \& Dinner study medication - Rabeprazole, placebo for tricyclic antidepressant at bedtime
|
Arm 3
AcipHex 20 mg once daily, placebo once daily and nortriptyline once daily
Rabeprazole 20mg,placebo dinner ,Low dose Tricyclic Antidepressant: Rabeprazole (Breakfast) study medication, dinner placebo medication, tricyclic antidepressant at bedtime
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
0
|
|
Overall Study
Protocol Violation
|
1
|
1
|
4
|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
1
|
|
Overall Study
Adverse Event
|
3
|
1
|
10
|
Baseline Characteristics
Role of Pain Modulation in GERD Patients Who Failed Standard Dose PPI
Baseline characteristics by cohort
| Measure |
AciPhex 20 mg BID and Once Daily Placebo
n=59 Participants
AciPhex 20 mg BID and once daily placebo
Rabeprazole 20mg, placebo dinner and bedtime: Breakfast study medication - Rabeprazole 20mg, matching placebo at dinner , Placebo for tricyclic antidepressant at bedtime
|
AcipHex 20 mg Once Daily and BID Placebo
n=55 Participants
AcipHex 20 mg once daily and BID placebo
Rabeprazole 20 mg two times, Placebo at bedtime: Breakfast \& Dinner study medication - Rabeprazole, placebo for tricyclic antidepressant at bedtime
|
AcipHex 20 mg Once, Placebo Once, Nortriptyline
n=54 Participants
AcipHex 20 mg once daily, placebo once daily and nortriptyline once daily
Rabeprazole 20mg,placebo dinner ,Low dose Tricyclic Antidepressant: Rabeprazole (Breakfast) study medication, dinner placebo medication, tricyclic antidepressant at bedtime
|
Total
n=168 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
54.8 years
STANDARD_DEVIATION 13.4 • n=7 Participants
|
56 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
55.6 years
STANDARD_DEVIATION 13.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
120 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
59 participants
n=5 Participants
|
55 participants
n=7 Participants
|
54 participants
n=5 Participants
|
168 participants
n=4 Participants
|
|
Body Mass Index
|
29.4 kg/meter-squared
STANDARD_DEVIATION 6.1 • n=5 Participants
|
29.3 kg/meter-squared
STANDARD_DEVIATION 6.5 • n=7 Participants
|
29.8 kg/meter-squared
STANDARD_DEVIATION 4.6 • n=5 Participants
|
29.5 kg/meter-squared
STANDARD_DEVIATION 5.9 • n=4 Participants
|
PRIMARY outcome
Timeframe: Symptom control after 6 weeks of treatmentPopulation: intention to treat (ITT)
the number of days with Symptom Intensity Score \< 3 (better) for daytime heartburn during week 6 as compared to baseline
Outcome measures
| Measure |
Arm 1
n=53 Participants
AciPhex 20 mg BID and once daily placebo
Rabeprazole 20mg, placebo dinner and bedtime: Breakfast study medication - Rabeprazole 20mg, matching placebo at dinner , Placebo for tricyclic antidepressant at bedtime
|
Arm 2
n=48 Participants
AcipHex 20 mg once daily and BID placebo
Rabeprazole 20 mg two times, Placebo at bedtime: Breakfast \& Dinner study medication - Rabeprazole, placebo for tricyclic antidepressant at bedtime
|
Arm 3
n=39 Participants
AcipHex 20 mg once daily, placebo once daily and nortriptyline once daily
Rabeprazole 20mg,placebo dinner ,Low dose Tricyclic Antidepressant: Rabeprazole (Breakfast) study medication, dinner placebo medication, tricyclic antidepressant at bedtime
|
|---|---|---|---|
|
Daytime Heartburn, Number of Days in Week Symptoms Intensity Score < 3 (Better)
|
6.6 days
Standard Deviation 0.9
|
5.9 days
Standard Deviation 2.2
|
6.1 days
Standard Deviation 1.8
|
PRIMARY outcome
Timeframe: Symptom control after 6 weeks of treatmentPopulation: ITT
the number of days with Symptom Intensity Score \< 3 (better) for nighttime heartburn during week 6 as compared to baseline
Outcome measures
| Measure |
Arm 1
n=53 Participants
AciPhex 20 mg BID and once daily placebo
Rabeprazole 20mg, placebo dinner and bedtime: Breakfast study medication - Rabeprazole 20mg, matching placebo at dinner , Placebo for tricyclic antidepressant at bedtime
|
Arm 2
n=48 Participants
AcipHex 20 mg once daily and BID placebo
Rabeprazole 20 mg two times, Placebo at bedtime: Breakfast \& Dinner study medication - Rabeprazole, placebo for tricyclic antidepressant at bedtime
|
Arm 3
n=39 Participants
AcipHex 20 mg once daily, placebo once daily and nortriptyline once daily
Rabeprazole 20mg,placebo dinner ,Low dose Tricyclic Antidepressant: Rabeprazole (Breakfast) study medication, dinner placebo medication, tricyclic antidepressant at bedtime
|
|---|---|---|---|
|
Nighttime Heartburn, Number of Days in Week Symptom Activity Score <3 (Better) in Week 6 Compared to Baseline
|
6.6 days
Standard Deviation 0.9
|
5.8 days
Standard Deviation 2.0
|
6.0 days
Standard Deviation 1.6
|
PRIMARY outcome
Timeframe: Symptom control after 6 weeks of treatmentPopulation: ITT
the number of days with Symptom Intensity Score \< 3 (better) for acid regurgitation during week 6 as compared to baseline
Outcome measures
| Measure |
Arm 1
n=53 Participants
AciPhex 20 mg BID and once daily placebo
Rabeprazole 20mg, placebo dinner and bedtime: Breakfast study medication - Rabeprazole 20mg, matching placebo at dinner , Placebo for tricyclic antidepressant at bedtime
|
Arm 2
n=48 Participants
AcipHex 20 mg once daily and BID placebo
Rabeprazole 20 mg two times, Placebo at bedtime: Breakfast \& Dinner study medication - Rabeprazole, placebo for tricyclic antidepressant at bedtime
|
Arm 3
n=39 Participants
AcipHex 20 mg once daily, placebo once daily and nortriptyline once daily
Rabeprazole 20mg,placebo dinner ,Low dose Tricyclic Antidepressant: Rabeprazole (Breakfast) study medication, dinner placebo medication, tricyclic antidepressant at bedtime
|
|---|---|---|---|
|
Acid Regurgitation, Number of Days in Week Symptoms Intensity Score < 3 (Better)
|
6.7 days
Standard Deviation 0.8
|
5.9 days
Standard Deviation 2.1
|
6.3 days
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: end of studyPopulation: ITT
SF-36 Physical Component Score (higher number better quality of life), is a measure of overall physical quality of life distinct from mental health. The range is 0 - 100. It has been adjusted to US national norms so that a score of 50 corresponds to the national mean.
Outcome measures
| Measure |
Arm 1
n=53 Participants
AciPhex 20 mg BID and once daily placebo
Rabeprazole 20mg, placebo dinner and bedtime: Breakfast study medication - Rabeprazole 20mg, matching placebo at dinner , Placebo for tricyclic antidepressant at bedtime
|
Arm 2
n=48 Participants
AcipHex 20 mg once daily and BID placebo
Rabeprazole 20 mg two times, Placebo at bedtime: Breakfast \& Dinner study medication - Rabeprazole, placebo for tricyclic antidepressant at bedtime
|
Arm 3
n=39 Participants
AcipHex 20 mg once daily, placebo once daily and nortriptyline once daily
Rabeprazole 20mg,placebo dinner ,Low dose Tricyclic Antidepressant: Rabeprazole (Breakfast) study medication, dinner placebo medication, tricyclic antidepressant at bedtime
|
|---|---|---|---|
|
Health Related Quality of Life
|
42.0 units on a scale
Standard Deviation 10.3
|
37.7 units on a scale
Standard Deviation 11.0
|
37.7 units on a scale
Standard Deviation 11.0
|
Adverse Events
Arm 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Arm 3
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm 1
n=59 participants at risk
AciPhex 20 mg BID and once daily placebo
Rabeprazole 20mg, placebo dinner and bedtime: Breakfast study medication - Rabeprazole 20mg, matching placebo at dinner , Placebo for tricyclic antidepressant at bedtime
|
Arm 2
n=55 participants at risk
AcipHex 20 mg once daily and BID placebo
Rabeprazole 20 mg two times, Placebo at bedtime: Breakfast \& Dinner study medication - Rabeprazole, placebo for tricyclic antidepressant at bedtime
|
Arm 3
n=54 participants at risk
AcipHex 20 mg once daily, placebo once daily and nortriptyline once daily
Rabeprazole 20mg,placebo dinner ,Low dose Tricyclic Antidepressant: Rabeprazole (Breakfast) study medication, dinner placebo medication, tricyclic antidepressant at bedtime
|
|---|---|---|---|
|
General disorders
Flu like symptoms
|
0.00%
0/59 • 6 weeks
|
1.8%
1/55 • 6 weeks
|
0.00%
0/54 • 6 weeks
|
|
Gastrointestinal disorders
skin ulceration
|
1.7%
1/59 • 6 weeks
|
0.00%
0/55 • 6 weeks
|
0.00%
0/54 • 6 weeks
|
|
Skin and subcutaneous tissue disorders
Other, Skin and subcutaneous tissue disorders
|
1.7%
1/59 • 6 weeks
|
0.00%
0/55 • 6 weeks
|
0.00%
0/54 • 6 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/59 • 6 weeks
|
0.00%
0/55 • 6 weeks
|
3.7%
2/54 • 6 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/59 • 6 weeks
|
0.00%
0/55 • 6 weeks
|
5.6%
3/54 • 6 weeks
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
1.7%
1/59 • 6 weeks
|
0.00%
0/55 • 6 weeks
|
0.00%
0/54 • 6 weeks
|
|
Nervous system disorders
Somnolence
|
1.7%
1/59 • 6 weeks
|
0.00%
0/55 • 6 weeks
|
5.6%
3/54 • 6 weeks
|
|
Renal and urinary disorders
Other, Renal and urinary disorders
|
0.00%
0/59 • 6 weeks
|
0.00%
0/55 • 6 weeks
|
1.9%
1/54 • 6 weeks
|
|
Vascular disorders
Flushing
|
0.00%
0/59 • 6 weeks
|
0.00%
0/55 • 6 weeks
|
1.9%
1/54 • 6 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/59 • 6 weeks
|
0.00%
0/55 • 6 weeks
|
1.9%
1/54 • 6 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/59 • 6 weeks
|
0.00%
0/55 • 6 weeks
|
1.9%
1/54 • 6 weeks
|
|
Eye disorders
Blurred vision
|
0.00%
0/59 • 6 weeks
|
0.00%
0/55 • 6 weeks
|
3.7%
2/54 • 6 weeks
|
|
Nervous system disorders
Lethargy
|
0.00%
0/59 • 6 weeks
|
0.00%
0/55 • 6 weeks
|
1.9%
1/54 • 6 weeks
|
|
General disorders
Fatigue
|
0.00%
0/59 • 6 weeks
|
0.00%
0/55 • 6 weeks
|
1.9%
1/54 • 6 weeks
|
Additional Information
Christopher Wendel, MS
Southern Arizona VA Health Care System
Phone: 520 792 1450
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place