Trial Outcomes & Findings for Efficacy and Safety of Quadruple Therapy in Eradication of H. Pylori: A Comparison to Triple Therapy (NCT NCT00669955)

NCT ID: NCT00669955

Last Updated: 2017-03-16

Results Overview

H. pylori Eradication defined as a negative C13-UBT (urea breath test) result at both Week 6 and Week 10 follow-up visits.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 440 participants
• Primary outcome timeframe: Week 6 and week 10 follow-up visits
• Results posted on: 2017-03-16

Participant Flow

First patient in: 11 June 2008 Last patient out: 22 June 2009 Patients were recruited from clinics and hospitals located in seven European Countries: Germany, Poland, Italy, France, Ireland, Spain, United Kingdom.

If patient was on any contraindicated medications, such as H2 antagonists, sucralfate, or proton pump inhibitors, a washout period of 2 weeks began following informed consent signature, and patient returned to the clinic to perform the endoscopy and the C-13 UBT. Presence of H. pylori needed to be confirmed by C-13 UBT and RUT at least.

Participant milestones

Measure	Quadruple Therapy (OBMT) 10 Days Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)	Triple Therapy (OAC) 7 Days Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
Overall Study STARTED	218	222
Overall Study COMPLETED	204	195
Overall Study NOT COMPLETED	14	27

Reasons for withdrawal

Measure	Quadruple Therapy (OBMT) 10 Days Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)	Triple Therapy (OAC) 7 Days Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
Overall Study Adverse Event	3	5
Overall Study Death	0	1
Overall Study Withdrawal by Subject	2	3
Overall Study Lost to Follow-up	5	7
Overall Study Protocol Violation	2	7
Overall Study Investigator Sponsor Judgement	0	1
Overall Study not compliant with study drug/visit	2	3

Baseline Characteristics

Efficacy and Safety of Quadruple Therapy in Eradication of H. Pylori: A Comparison to Triple Therapy

Baseline characteristics by cohort

Measure	Quadruple Therapy (OBMT) 10 Days n=218 Participants Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)	Triple Therapy (OAC) 7 Days n=222 Participants Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID	Total n=440 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	184 Participants n=5 Participants	194 Participants n=7 Participants	378 Participants n=5 Participants
Age, Categorical >=65 years	34 Participants n=5 Participants	28 Participants n=7 Participants	62 Participants n=5 Participants
Age, Continuous	48.53 years STANDARD_DEVIATION 14.64 • n=5 Participants	47.95 years STANDARD_DEVIATION 14.52 • n=7 Participants	48.24 years STANDARD_DEVIATION 14.58 • n=5 Participants
Sex: Female, Male Female	105 Participants n=5 Participants	100 Participants n=7 Participants	205 Participants n=5 Participants
Sex: Female, Male Male	113 Participants n=5 Participants	122 Participants n=7 Participants	235 Participants n=5 Participants
Region of Enrollment Italy	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants
Region of Enrollment Spain	7 participants n=5 Participants	6 participants n=7 Participants	13 participants n=5 Participants
Region of Enrollment France	15 participants n=5 Participants	17 participants n=7 Participants	32 participants n=5 Participants
Region of Enrollment Germany	92 participants n=5 Participants	91 participants n=7 Participants	183 participants n=5 Participants
Region of Enrollment Poland	91 participants n=5 Participants	93 participants n=7 Participants	184 participants n=5 Participants
Region of Enrollment United Kingdom	3 participants n=5 Participants	5 participants n=7 Participants	8 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 6 and week 10 follow-up visits

Population: No imputation method used, as this is the per protocol population, which excludes patients with missing values, or with protocol violations.

H. pylori Eradication defined as a negative C13-UBT (urea breath test) result at both Week 6 and Week 10 follow-up visits.

Outcome measures

Measure	Quadruple Therapy (OBMT) 10 Days n=178 Participants Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)	Triple Therapy (OAC) 7 Days n=161 Participants Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
Helicobacter Pylori Eradication Confirmed by Urea Breath Test	166 Participants	112 Participants

SECONDARY outcome

Timeframe: at the end of treatment (day 8-14), week 6 and wek 10 follow-up visits.

Population: Safety population, described as all randomized patients having received at least one dose of study medication

A treatment-emergent adverse event is defined as an event not present prior to exposure to the study medication or any event already present that worsens in either intensity or frequency following exposure to study medication up to 30 days after study discontinuation.

All safety analysis based on the safety population.

Outcome measures

Measure	Quadruple Therapy (OBMT) 10 Days n=216 Participants Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)	Triple Therapy (OAC) 7 Days n=222 Participants Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
Number of Patients Experiencing Treatment Emergent Adverse Events.	101 Participants	112 Participants

SECONDARY outcome

Timeframe: Week 6 and week 10 follow-up visits

Population: Per protocol population.

Eradication rates in the subset of patients with peptic ulcer (current or past history) at baseline are reported based on the per protocol population. Eradication must be confirmed at week 6 and week 10 by a negative Urea Breath Test conducted within the allocated windows.

Outcome measures

Measure	Quadruple Therapy (OBMT) 10 Days n=19 Participants Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)	Triple Therapy (OAC) 7 Days n=18 Participants Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
H. Pylori Eradication and Presence or Past History of Peptic Ulcers	18 Participants	15 Participants

SECONDARY outcome

Timeframe: Measured at baseline

Population: Per protocol analysis population

Eradication rates in subset of patients infected with a bacterial strain confirmed as resistant to clarithromycin at baseline. Resistance to clarithromycin defined as Minimum Inhibitory Concentration (MIC) of 1 ug/ml and above

Outcome measures

Measure	Quadruple Therapy (OBMT) 10 Days n=33 Participants Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)	Triple Therapy (OAC) 7 Days n=25 Participants Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
Clarithromycin Resistance	30 participants	2 participants

SECONDARY outcome

Timeframe: Measured at baseline

Population: Per protocol population

Eradication rates in subset of patients infected with a bacterial strain confirmed as resistant to metronidazole at baseline. Resistance to metronidazole defined as Minimum Inhibitory Concentration (MIC) above 8 ug/ml

Outcome measures

Measure	Quadruple Therapy (OBMT) 10 Days n=42 Participants Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)	Triple Therapy (OAC) 7 Days n=41 Participants Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
Metronidazole Resistance	38 participants	28 participants

SECONDARY outcome

Timeframe: At the end of the treatment phase (days 8-14)

Population: Safety population.

Overall compliance: number of capsules dispensed - number of capsules returned/Number of prescribed capsules X 100. Percentages based on safety population

Outcome measures

Measure	Quadruple Therapy (OBMT) 10 Days n=216 Participants Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)	Triple Therapy (OAC) 7 Days n=218 Participants Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
Overall Compliance to Study Medications	97.58 participants Standard Deviation 10.71	97.47 participants Standard Deviation 14.91

SECONDARY outcome

Timeframe: Baseline (both arms), end of treatment (Day 11-14) and end of study (Day 70) OBMT arm only

Population: Plasma bismuth concentrations were analysed in the OBMT arm only. The goal was to determine whether bismuth plasma concentrations would be of 50 ug/l or above at end of treatment, or at the end of study. The results report the number of patients having reached 50 ug/l in the OBMT arm at either of these timepoints.

Tolerability of OBMT with respect to plasma bismuth concentrations: number of patients with bismuth concentrations above the toxic level (50 ug per liter)

Outcome measures

Measure	Quadruple Therapy (OBMT) 10 Days n=216 Participants Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)	Triple Therapy (OAC) 7 Days Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
Number of Patients With Bismuth Plasma Concentrations Above the Toxic Level	0 participants	—

Adverse Events

Quadruple Therapy (OBMT) 10 Days

Serious events: 4 serious events

Other events: 98 other events

Deaths: 0 deaths

Triple Therapy (OAC) 7 Days

Serious events: 3 serious events

Other events: 105 other events

Deaths: 0 deaths

Serious adverse events

Measure	Quadruple Therapy (OBMT) 10 Days n=216 participants at risk Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)	Triple Therapy (OAC) 7 Days n=222 participants at risk Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
Infections and infestations Appendicitis	0.00% 0/216 • Adverse events were recorded starting at the signing of the informed consent until the final visit (Day 70) or early withdrawal visit. Serious adverse events were followed until 30 days after the patient had stopped study participation. Systematic assessment done for laboratory evaluations and bismuth plasma levels.	0.45% 1/222 • Number of events 1 • Adverse events were recorded starting at the signing of the informed consent until the final visit (Day 70) or early withdrawal visit. Serious adverse events were followed until 30 days after the patient had stopped study participation. Systematic assessment done for laboratory evaluations and bismuth plasma levels.
General disorders Condition aggravated	0.00% 0/216 • Adverse events were recorded starting at the signing of the informed consent until the final visit (Day 70) or early withdrawal visit. Serious adverse events were followed until 30 days after the patient had stopped study participation. Systematic assessment done for laboratory evaluations and bismuth plasma levels.	0.45% 1/222 • Number of events 1 • Adverse events were recorded starting at the signing of the informed consent until the final visit (Day 70) or early withdrawal visit. Serious adverse events were followed until 30 days after the patient had stopped study participation. Systematic assessment done for laboratory evaluations and bismuth plasma levels.
Metabolism and nutrition disorders Dehydration	0.00% 0/216 • Adverse events were recorded starting at the signing of the informed consent until the final visit (Day 70) or early withdrawal visit. Serious adverse events were followed until 30 days after the patient had stopped study participation. Systematic assessment done for laboratory evaluations and bismuth plasma levels.	0.45% 1/222 • Number of events 1 • Adverse events were recorded starting at the signing of the informed consent until the final visit (Day 70) or early withdrawal visit. Serious adverse events were followed until 30 days after the patient had stopped study participation. Systematic assessment done for laboratory evaluations and bismuth plasma levels.
Skin and subcutaneous tissue disorders Eczema	0.46% 1/216 • Number of events 1 • Adverse events were recorded starting at the signing of the informed consent until the final visit (Day 70) or early withdrawal visit. Serious adverse events were followed until 30 days after the patient had stopped study participation. Systematic assessment done for laboratory evaluations and bismuth plasma levels.	0.00% 0/222 • Adverse events were recorded starting at the signing of the informed consent until the final visit (Day 70) or early withdrawal visit. Serious adverse events were followed until 30 days after the patient had stopped study participation. Systematic assessment done for laboratory evaluations and bismuth plasma levels.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal carcinoma	0.46% 1/216 • Number of events 1 • Adverse events were recorded starting at the signing of the informed consent until the final visit (Day 70) or early withdrawal visit. Serious adverse events were followed until 30 days after the patient had stopped study participation. Systematic assessment done for laboratory evaluations and bismuth plasma levels.	0.00% 0/222 • Adverse events were recorded starting at the signing of the informed consent until the final visit (Day 70) or early withdrawal visit. Serious adverse events were followed until 30 days after the patient had stopped study participation. Systematic assessment done for laboratory evaluations and bismuth plasma levels.
Metabolism and nutrition disorders Malnutrition	0.00% 0/216 • Adverse events were recorded starting at the signing of the informed consent until the final visit (Day 70) or early withdrawal visit. Serious adverse events were followed until 30 days after the patient had stopped study participation. Systematic assessment done for laboratory evaluations and bismuth plasma levels.	0.45% 1/222 • Number of events 1 • Adverse events were recorded starting at the signing of the informed consent until the final visit (Day 70) or early withdrawal visit. Serious adverse events were followed until 30 days after the patient had stopped study participation. Systematic assessment done for laboratory evaluations and bismuth plasma levels.
Gastrointestinal disorders Pancreatitis	0.00% 0/216 • Adverse events were recorded starting at the signing of the informed consent until the final visit (Day 70) or early withdrawal visit. Serious adverse events were followed until 30 days after the patient had stopped study participation. Systematic assessment done for laboratory evaluations and bismuth plasma levels.	0.45% 1/222 • Number of events 1 • Adverse events were recorded starting at the signing of the informed consent until the final visit (Day 70) or early withdrawal visit. Serious adverse events were followed until 30 days after the patient had stopped study participation. Systematic assessment done for laboratory evaluations and bismuth plasma levels.
Infections and infestations Proteus infection	0.46% 1/216 • Number of events 1 • Adverse events were recorded starting at the signing of the informed consent until the final visit (Day 70) or early withdrawal visit. Serious adverse events were followed until 30 days after the patient had stopped study participation. Systematic assessment done for laboratory evaluations and bismuth plasma levels.	0.00% 0/222 • Adverse events were recorded starting at the signing of the informed consent until the final visit (Day 70) or early withdrawal visit. Serious adverse events were followed until 30 days after the patient had stopped study participation. Systematic assessment done for laboratory evaluations and bismuth plasma levels.
General disorders Pyrexia	0.00% 0/216 • Adverse events were recorded starting at the signing of the informed consent until the final visit (Day 70) or early withdrawal visit. Serious adverse events were followed until 30 days after the patient had stopped study participation. Systematic assessment done for laboratory evaluations and bismuth plasma levels.	0.45% 1/222 • Number of events 1 • Adverse events were recorded starting at the signing of the informed consent until the final visit (Day 70) or early withdrawal visit. Serious adverse events were followed until 30 days after the patient had stopped study participation. Systematic assessment done for laboratory evaluations and bismuth plasma levels.
Renal and urinary disorders Renal artery stenosis	0.46% 1/216 • Number of events 1 • Adverse events were recorded starting at the signing of the informed consent until the final visit (Day 70) or early withdrawal visit. Serious adverse events were followed until 30 days after the patient had stopped study participation. Systematic assessment done for laboratory evaluations and bismuth plasma levels.	0.00% 0/222 • Adverse events were recorded starting at the signing of the informed consent until the final visit (Day 70) or early withdrawal visit. Serious adverse events were followed until 30 days after the patient had stopped study participation. Systematic assessment done for laboratory evaluations and bismuth plasma levels.
Renal and urinary disorders Renal failure acute	0.46% 1/216 • Number of events 1 • Adverse events were recorded starting at the signing of the informed consent until the final visit (Day 70) or early withdrawal visit. Serious adverse events were followed until 30 days after the patient had stopped study participation. Systematic assessment done for laboratory evaluations and bismuth plasma levels.	0.00% 0/222 • Adverse events were recorded starting at the signing of the informed consent until the final visit (Day 70) or early withdrawal visit. Serious adverse events were followed until 30 days after the patient had stopped study participation. Systematic assessment done for laboratory evaluations and bismuth plasma levels.
Psychiatric disorders Schizophrenia	0.46% 1/216 • Number of events 1 • Adverse events were recorded starting at the signing of the informed consent until the final visit (Day 70) or early withdrawal visit. Serious adverse events were followed until 30 days after the patient had stopped study participation. Systematic assessment done for laboratory evaluations and bismuth plasma levels.	0.00% 0/222 • Adverse events were recorded starting at the signing of the informed consent until the final visit (Day 70) or early withdrawal visit. Serious adverse events were followed until 30 days after the patient had stopped study participation. Systematic assessment done for laboratory evaluations and bismuth plasma levels.
Nervous system disorders Vascular dementia	0.00% 0/216 • Adverse events were recorded starting at the signing of the informed consent until the final visit (Day 70) or early withdrawal visit. Serious adverse events were followed until 30 days after the patient had stopped study participation. Systematic assessment done for laboratory evaluations and bismuth plasma levels.	0.45% 1/222 • Number of events 1 • Adverse events were recorded starting at the signing of the informed consent until the final visit (Day 70) or early withdrawal visit. Serious adverse events were followed until 30 days after the patient had stopped study participation. Systematic assessment done for laboratory evaluations and bismuth plasma levels.
Cardiac disorders Ventricular extrasystoles	0.00% 0/216 • Adverse events were recorded starting at the signing of the informed consent until the final visit (Day 70) or early withdrawal visit. Serious adverse events were followed until 30 days after the patient had stopped study participation. Systematic assessment done for laboratory evaluations and bismuth plasma levels.	0.45% 1/222 • Number of events 1 • Adverse events were recorded starting at the signing of the informed consent until the final visit (Day 70) or early withdrawal visit. Serious adverse events were followed until 30 days after the patient had stopped study participation. Systematic assessment done for laboratory evaluations and bismuth plasma levels.
Gastrointestinal disorders Vomiting	0.00% 0/216 • Adverse events were recorded starting at the signing of the informed consent until the final visit (Day 70) or early withdrawal visit. Serious adverse events were followed until 30 days after the patient had stopped study participation. Systematic assessment done for laboratory evaluations and bismuth plasma levels.	0.45% 1/222 • Number of events 1 • Adverse events were recorded starting at the signing of the informed consent until the final visit (Day 70) or early withdrawal visit. Serious adverse events were followed until 30 days after the patient had stopped study participation. Systematic assessment done for laboratory evaluations and bismuth plasma levels.
Infections and infestations e coli urinary tract infection	0.46% 1/216 • Number of events 1 • Adverse events were recorded starting at the signing of the informed consent until the final visit (Day 70) or early withdrawal visit. Serious adverse events were followed until 30 days after the patient had stopped study participation. Systematic assessment done for laboratory evaluations and bismuth plasma levels.	0.00% 0/222 • Adverse events were recorded starting at the signing of the informed consent until the final visit (Day 70) or early withdrawal visit. Serious adverse events were followed until 30 days after the patient had stopped study participation. Systematic assessment done for laboratory evaluations and bismuth plasma levels.

Other adverse events

Measure	Quadruple Therapy (OBMT) 10 Days n=216 participants at risk Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)	Triple Therapy (OAC) 7 Days n=222 participants at risk Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
Gastrointestinal disorders Dyspepsia	10.2% 22/216 • Adverse events were recorded starting at the signing of the informed consent until the final visit (Day 70) or early withdrawal visit. Serious adverse events were followed until 30 days after the patient had stopped study participation. Systematic assessment done for laboratory evaluations and bismuth plasma levels.	13.5% 30/222 • Adverse events were recorded starting at the signing of the informed consent until the final visit (Day 70) or early withdrawal visit. Serious adverse events were followed until 30 days after the patient had stopped study participation. Systematic assessment done for laboratory evaluations and bismuth plasma levels.
Gastrointestinal disorders Diarrhea	6.5% 14/216 • Adverse events were recorded starting at the signing of the informed consent until the final visit (Day 70) or early withdrawal visit. Serious adverse events were followed until 30 days after the patient had stopped study participation. Systematic assessment done for laboratory evaluations and bismuth plasma levels.	12.6% 28/222 • Adverse events were recorded starting at the signing of the informed consent until the final visit (Day 70) or early withdrawal visit. Serious adverse events were followed until 30 days after the patient had stopped study participation. Systematic assessment done for laboratory evaluations and bismuth plasma levels.
Vascular disorders Abdominal pain upper	8.3% 18/216 • Adverse events were recorded starting at the signing of the informed consent until the final visit (Day 70) or early withdrawal visit. Serious adverse events were followed until 30 days after the patient had stopped study participation. Systematic assessment done for laboratory evaluations and bismuth plasma levels.	7.2% 16/222 • Adverse events were recorded starting at the signing of the informed consent until the final visit (Day 70) or early withdrawal visit. Serious adverse events were followed until 30 days after the patient had stopped study participation. Systematic assessment done for laboratory evaluations and bismuth plasma levels.
Gastrointestinal disorders Nausea	6.5% 14/216 • Adverse events were recorded starting at the signing of the informed consent until the final visit (Day 70) or early withdrawal visit. Serious adverse events were followed until 30 days after the patient had stopped study participation. Systematic assessment done for laboratory evaluations and bismuth plasma levels.	0.90% 2/222 • Adverse events were recorded starting at the signing of the informed consent until the final visit (Day 70) or early withdrawal visit. Serious adverse events were followed until 30 days after the patient had stopped study participation. Systematic assessment done for laboratory evaluations and bismuth plasma levels.
Nervous system disorders Dysgeusia	5.6% 12/216 • Adverse events were recorded starting at the signing of the informed consent until the final visit (Day 70) or early withdrawal visit. Serious adverse events were followed until 30 days after the patient had stopped study participation. Systematic assessment done for laboratory evaluations and bismuth plasma levels.	9.9% 22/222 • Adverse events were recorded starting at the signing of the informed consent until the final visit (Day 70) or early withdrawal visit. Serious adverse events were followed until 30 days after the patient had stopped study participation. Systematic assessment done for laboratory evaluations and bismuth plasma levels.
Gastrointestinal disorders Headache	8.3% 18/216 • Adverse events were recorded starting at the signing of the informed consent until the final visit (Day 70) or early withdrawal visit. Serious adverse events were followed until 30 days after the patient had stopped study participation. Systematic assessment done for laboratory evaluations and bismuth plasma levels.	3.2% 7/222 • Adverse events were recorded starting at the signing of the informed consent until the final visit (Day 70) or early withdrawal visit. Serious adverse events were followed until 30 days after the patient had stopped study participation. Systematic assessment done for laboratory evaluations and bismuth plasma levels.

Additional Information

Monique Giguere, PhD, Programs Director,

Axcan Pharma Inc.

Phone: 1-800-565-3255

Results disclosure agreements

• Principal investigator is a sponsor employee Restrictions vary in accordance with the agreement with investigators. Axcan will allow publication after a multi-centre publication or after an agreed period, subject to review by Axcan for confidentiality and intellectual protection.
• Publication restrictions are in place

Restriction type: OTHER