Trial Outcomes & Findings for Efficacy and Safety Study of Esomeprazole 20mg qd vs Ranitidine 150mg Bid in Patients With an NSAID-induced Gastric Ulcer (NCT NCT00401752)

NCT ID: NCT00401752

Last Updated: 2010-07-08

Results Overview

Healed was defined as the absence of gastric ulcers. It was calculated as the proportion of subjects whose gastric ulcer(s) healed after 4 weeks treatment. (Ulcers were on S stage, stage 1 = Nonblanchable erythema of intact skin, stage 2 = Partial thickness skin loss involving epidermis, dermis, or both, stage 3 = Full thickness skin loss involving damage to or necrosis of subcutaneous tissue, stage 4 = Full thickness skin loss with extensive destruction, tissue necrosis, or damage to muscle, bone, or supporting structures or absent).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 397 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2010-07-08

Participant Flow

Total 219 patients from 18 centers in China who had been receiving a stable daily dose of 1 or more NSAIDs for at least 2 weeks and who had an NSAID-associated GU verified by EGD at baseline were randomized. The first patient was enrolled on 31 Mar 2006, the last patient was completed on 17 Nov 2008.

Total 397 patients from 24 centers in China were enrolled. 178 patients were not randomised due to unwillingness to continue the study or development of any exclusion criteria, etc. Total 219 patients were randomised, 217 patients were included in ITT population.

Participant milestones

Measure	Esomeprazole Esomeprazole 20 mg tablet qd oral administration	Ranitidine ranitidine 150 mg capsule bid oral administration
Overall Study STARTED	107	112
Overall Study Number of Patients Received Treatment	107	111
Overall Study Patients Included in ITT Population	106	111
Overall Study Patients Included in Safety Population	107	110
Overall Study Patients Included in Per-Protocol Popula	100	99
Overall Study COMPLETED	97	94
Overall Study NOT COMPLETED	10	18

Reasons for withdrawal

Measure	Esomeprazole Esomeprazole 20 mg tablet qd oral administration	Ranitidine ranitidine 150 mg capsule bid oral administration
Overall Study Adverse Event	2	5
Overall Study Withdrawal by Subject	2	6
Overall Study Lost to Follow-up	1	4
Overall Study Development of any exclusion criteria	4	2
Overall Study Physician Decision	1	1

Baseline Characteristics

Efficacy and Safety Study of Esomeprazole 20mg qd vs Ranitidine 150mg Bid in Patients With an NSAID-induced Gastric Ulcer

Baseline characteristics by cohort

Measure	Esomeprazole n=106 Participants Esomeprazole 20 mg tablet qd oral administration	Ranitidine n=111 Participants ranitidine 150 mg capsule bid oral administration	Total n=217 Participants Total of all reporting groups
Age Continuous	49.7 year STANDARD_DEVIATION 11.01 • n=93 Participants	50.9 year STANDARD_DEVIATION 10.2 • n=4 Participants	50.3 year STANDARD_DEVIATION 10.6 • n=27 Participants
Sex: Female, Male Female	51 Participants n=93 Participants	53 Participants n=4 Participants	104 Participants n=27 Participants
Sex: Female, Male Male	55 Participants n=93 Participants	58 Participants n=4 Participants	113 Participants n=27 Participants

PRIMARY outcome

Timeframe: 4 weeks

Healed was defined as the absence of gastric ulcers. It was calculated as the proportion of subjects whose gastric ulcer(s) healed after 4 weeks treatment.

(Ulcers were on S stage, stage 1 = Nonblanchable erythema of intact skin, stage 2 = Partial thickness skin loss involving epidermis, dermis, or both, stage 3 = Full thickness skin loss involving damage to or necrosis of subcutaneous tissue, stage 4 = Full thickness skin loss with extensive destruction, tissue necrosis, or damage to muscle, bone, or supporting structures or absent).

Outcome measures

Measure	Esomeprazole n=106 Participants Esomeprazole 20 mg tablet qd oral administration	Ranitidine n=111 Participants ranitidine 150 mg capsule bid oral administration
The Percentage of Subjects Whose Gastric Ulcer(s) (GUs) Was (Were) Healed at Week 4 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily Non-steroidal Anti-inflammatory Drug (NSAID)Therapy.	59.4 Percentage of participants	59.5 Percentage of participants

SECONDARY outcome

Timeframe: 8 weeks

Healed was defined as the absence of gastric ulcers (Ulcers were on S stage or absent). It was calculated as the proportion of subjects whose gastric ulcer(s) healed after 8 weeks treatment.

Outcome measures

Measure	Esomeprazole n=106 Participants Esomeprazole 20 mg tablet qd oral administration	Ranitidine n=111 Participants ranitidine 150 mg capsule bid oral administration
The Percentage of Subjects Whose Gastric Ulcer(s) Was (Were) Healed at Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy.	81.1 Percentage of participants	73.9 Percentage of participants

SECONDARY outcome

Timeframe: week 4 and week 8

Resolution rate of investigator-assessed GI symptoms, including heartburn, acid regurgitation, nausea, abdominal fullness and sleep disorder. It was calculated as the percentage of subjects whose heartburn symptoms were resolved at Week 8.

Outcome measures

Measure	Esomeprazole n=106 Participants Esomeprazole 20 mg tablet qd oral administration	Ranitidine n=111 Participants ranitidine 150 mg capsule bid oral administration
The Resolution of Heartburn Symptoms at Week 4 and Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy.	100 Percentage of participants	97.7 Percentage of participants

SECONDARY outcome

Timeframe: 8 weeks

Population: Patients included in safety population

Safety evaluation including vital signs, physical examination, ECG, adverse events and clinical laboratory evaluations during 8 weeks treatment.

Outcome measures

Measure	Esomeprazole n=107 Participants Esomeprazole 20 mg tablet qd oral administration	Ranitidine n=110 Participants ranitidine 150 mg capsule bid oral administration
Percentage of Participants With the Occurance of Any Adverse Event.	16.8 Percentage of participants	22.7 Percentage of participants

SECONDARY outcome

Timeframe: 4 and 8 week

Healed was defined as the absence of ulcers (Ulcers were on S stage or absent). It was calculated as the proportion of subjects whose duodenal ulcer healed after 4 and 8 weeks treatment.

Outcome measures

Measure	Esomeprazole n=15 Participants Esomeprazole 20 mg tablet qd oral administration	Ranitidine n=22 Participants ranitidine 150 mg capsule bid oral administration
The Percentage of Participants Whose Duodenal Ulcer(s) (DUs) Was (Were) Healed at Week 4 and Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy.	93.3 Percentage of participants	81.8 Percentage of participants

SECONDARY outcome

Timeframe: 4 & 8 weeks

Healed was defined as the absence of ulcers (Ulcers were on S stage or absent). It was calculated as the proportion of subjects whose gastric and duodenal ulcer healed after 4 and 8 weeks treatment.

Outcome measures

Measure	Esomeprazole n=106 Participants Esomeprazole 20 mg tablet qd oral administration	Ranitidine n=111 Participants ranitidine 150 mg capsule bid oral administration
The Percentage of Participants Whose GU(s) and DU(s) in Combination Were Healed at Week 4 and Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy	80.2 Percentage of participants	69.4 Percentage of participants

Adverse Events

Esomeprazole

Serious events: 2 serious events

Other events: 13 other events

Deaths: 0 deaths

Ranitidine

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Measure	Esomeprazole n=107 participants at risk Esomeprazole 20 mg tablet qd oral administration	Ranitidine n=110 participants at risk ranitidine 150 mg capsule bid oral administration
Gastrointestinal disorders Gastric Cancer	1.9% 2/107	0.00% 0/110
Gastrointestinal disorders GU Haemorrhage	0.00% 0/107	0.91% 1/110
Skin and subcutaneous tissue disorders Erythrodermic Psoriasis	0.00% 0/107	0.91% 1/110

Other adverse events

Measure	Esomeprazole n=107 participants at risk Esomeprazole 20 mg tablet qd oral administration	Ranitidine n=110 participants at risk ranitidine 150 mg capsule bid oral administration
Nervous system disorders Dizziness	0.00% 0/107	4.5% 5/110
Gastrointestinal disorders Gastritis erosive	2.8% 3/107	3.6% 4/110
Hepatobiliary disorders Alanine aminotransferase increased	1.9% 2/107	0.00% 0/110
Hepatobiliary disorders Aspartate aminotransferase increased	1.9% 2/107	0.00% 0/110
Gastrointestinal disorders Gastric ulcer	1.9% 2/107	0.91% 1/110
Gastrointestinal disorders Abdominal pain upper	0.93% 1/107	1.8% 2/110
Respiratory, thoracic and mediastinal disorders Upper respiratory tract infection	0.93% 1/107	1.8% 2/110
Gastrointestinal disorders Duodenal ulcer	0.00% 0/107	1.8% 2/110
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric Cancer	1.9% 2/107	0.00% 0/110

Additional Information

Gerard Lynch

AstraZeneca

Email: aztrial_results_posting@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60