Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers Compared to Non-steroidal Antiinflammatory Drug (NSAID) Naproxen
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|ClinicalTrials.gov Identifier: NCT00527787|
Recruitment Status : Completed
First Posted : September 11, 2007
Results First Posted : December 28, 2010
Last Update Posted : December 28, 2010
|Condition or disease||Intervention/treatment||Phase|
|Gastric Ulcer||Drug: PN400 (VIMOVO) Drug: Naproxen||Phase 3|
Primary: To demonstrate that PN400 is effective in reducing the risk of gastric ulcers in subjects at risk for developing NSAID-associated gastric ulcers.
- To determine if PN400 is effective in reducing the risk of duodenal ulcers in subjects at risk for developing NSAID-associated ulcers
- To compare upper gastrointestinal symptoms in subjects treated with PN400 versus naproxen as measured by scores on the Severity of Dyspepsia Assessment (SODA) instrument and the Overall Treatment Evaluation - Dyspepsia (OTE-DP)
- To compare heartburn symptoms in subjects treated with PN400 versus naproxen
- To evaluate the safety and tolerability of PN400 and naproxen
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||434 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||6-Month, Phase 3, Randomized, Double-blind, Parallel-group, Controlled, Multi-center Study Evaluate Gastric Ulcer Incidence Following Administration of PN400 or Naproxen in Subjects Who Are at Risk for Developing NSAID-associated Ulcers|
|Study Start Date :||September 2007|
|Primary Completion Date :||October 2008|
|Study Completion Date :||October 2008|
Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily
Drug: PN400 (VIMOVO)
PN400 tablets (Naproxen 500 mg and Esomeprazole 20 mg) twice daily (bid) taken orally.
Other Name: Vimovo
Active Comparator: Naproxen
Naproxen 500 mg dosed twice daily
Naproxen (500 mg) dosed twice daily (bid) orally
Other Name: Naprosyn
- Number of Participants With Gastric Ulcer Confirmed by Endoscopy [ Time Frame: 6 months ]The primary efficacy endpoint was the number of subjects with gastric ulcers at any time throughout 6 months of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter (measured by close application of open endoscopic biopsy forceps) with unequivocal crater depth. A subject is considered to have completed the study if all scheduled assessments up through the 6 month visit have been performed or if the endpoint of gastric ulcer confirmed by endoscopy has been reached.
- The Number of Participants With Pre-Specified NSAID-Associated Upper GI Adverse Events or Duodenal Ulcers [ Time Frame: 6 months ]The Number of Participants with Pre-Specified non-steroidal antiinflammatory drug (NSAID)-Associated Upper Gastrointestinal (UGI) Adverse Events or Duodenal Ulcers after 6 months of treatment. Pre-specified UGI adverse events typically associated with NSAID use include dyspepsia, abdominal pain, gastritis, erosive esophagitis, duodenitis, abdominal discomfort
- The Number of Participants Discontinuing From the Study Due to NSAID-Associated Upper GI Adverse Events or to Duodenal Ulcer [ Time Frame: 6 Months ]The Number of Participants Discontinuing from the Study Due to non-steroidal antiinflammatory drug (NSAID)-Associated Upper GI Adverse Events or to Duodenal Ulcer during the treatment period
- The Number of Participants Developing Duodenal Ulcers Throughout 6 Months of Treatment [ Time Frame: 6 months ]The Number of Participants Developing Duodenal Ulcers at any time during the 6 Months of the treatment period
- Heartburn Symptom Resolution, ie no Heartburn Symptoms During the Last 7 Days Prior to the Visit [ Time Frame: 6 months ]
Subjects were asked whether heartburn symptoms within the 7 days prior to the visit were:
- none: no symptoms
- mild: awareness of symptom, but easily tolerated
- moderate: discomforting symptom sufficient to cause interference with normal activities (including sleep)
- severe: incapacitating symptom, with inability to perform normal activities (including sleep) Heartburn was defined as a burning feeling rising from the stomach or lower part of the chest towards the neck.
- Improvement From Baseline in Upper Abdominal Pain and Discomfort Scores at 6 Months, Based on the Overall Treatment Evaluation for Dyspepsia Questionnaire [ Time Frame: change from baseline at 6 Months ]Improvement from baseline in Upper Abdominal Pain and Discomfort scores at 6 months, based on the overall Treatment Evaluation for Dyspepsia Questionnaire. Subjects were asked: "since treatment started, has there been any change in your upper abdominal pain and/or discomfort?" Answers would be better/about the same/worse. Participants with the response "better" (instead of "about the same" or "worse"), are tabulated by treatment group.
- Mean Change From Baseline on Pain Intensity of the Severity of Dyspepsia Assessment (SODA) Subscales [ Time Frame: baseline to 6 Months ]Mean Change from Baseline on Pain Intensity of the Severity of Dyspepsia Assessment (SODA) Subscales. There are 6 questions about abdominal pain during the past 7 days: q 1-5 on average: 1. rate with a number between 0 (no pain) and 100 (pain as bad as it could be), 2. rate with a number between 0 (no discomfort) and 10 (discomfort as bad as it can be), 3. on a scale of 5 (from none to excriciating), 4. on 100 mm VAS, 5. on a scale of 4 and 6. worst abdominal pain scale 0 (no discomfort) and 10 (discomfort as bad as it can be). Total composite possible range for "pain intensity" is: 2-47
- Mean Change From Baseline on Non-Pain Symptoms of the Severity of Dyspepsia Assessment (SODA) Subscales [ Time Frame: baseline to 6 Months ]Change from Baseline of Non-Pain Symptoms on the SODA Assessment. There are 7 categories about the non-pain symptoms: burping/beching, heartburn, bloating, passing gas, sour taste, nausea and bad breath. For each of these categories, subjects were to rate during the past seven days, on average, the severity on a 5 point scale ranging from no problem to very severe problem. The scores are combined into a single composite score. The total possible range of the non-pain symptoms subscale is: 7-35.
- Mean Change From Baseline on Satisfaction of the Severity of Dyspepsia Assessment (SODA) Subscales [ Time Frame: baseline to 6 Months ]Mean Change in Satisfaction on SODA Assessment. Questions/statements to rate about satisfaction/dissatisfaction with their present level of abdominal discomfort. Question 1: 4-point scale range 0 (extremely unhappy) to 4 (extremely happy), statement 2 (I feel satisfied with my health with regard to abdominal discomfort) & statement 3 (I am pleased because my abdominal discomfort seems under control) on a 5 point scale (definitely true to definitely false) & question 4 rated how pleased subjects were with abdominal discomfort on a 10 point scale. Total satisfaction composite range: 2-23
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00527787
|United States, North Carolina|
|Chapel Hill, North Carolina, United States, 27517|
|Study Chair:||Everardus Orlemans, PhD||POZEN|