OsteoarthritisPhase 1NCT00392080
A Study Of The Effect Of CJ-023,423 On The Incidence Of Stomach Ulcers
A Phase 1 study testing CJ-023,423 and naproxen in people with Osteoarthritis, run by Pfizer at 11 sites in United States.
Trial summary
CJ-023,423 is a new medication being developed as an anti-inflammatory agent for the treatment of the signs and symptoms of osteoarthritis (OA). The purpose of this study is to evaluate whether patients treated with CJ-023,423 for 7 days (14 doses) have fewer gastrointestinal ulcers compared to patients treated with… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- CJ-023,423 and naproxen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 340 participants
- Where
- 11 sitesUnited States
- Study dates
- Nov 2006to Feb 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Is a healthy adult 18 to 75 years of age, inclusive; healthy is defined as no clinically relevant abnormalities identified as detailed medical history, full physical examination, including blood pressure [BP] and pulse rate [PR]measurement, 12-lead electrocardiogram [ECG], and clinical safety laboratory tests
- If female and of childbearing potential (includes women who have been postmenopausal for < 2 years ), must be using adequate contraception, must not be lactating and must have had a negative serum pregnancy test at Screening and a negative urine pregnancy test result within 24 hours prior to receiving study drug. The site investigator must ensure that female subjects are not pregnant prior to receiving the first dose of drug;
Who cannot join
- Endoscopic evidence of inflammation, ulceration, erosion, petechiae, or active bleeding in the esophagus, stomach, pyloric channel, or duodenum at the baseline/ randomization (Day 1) endoscopy (Mucosal Grading Scale score >0);
- Active GI disease (e.g. inflammatory bowel disease), a history of gastroduodenal ulcers or bleeding, or a history of any gastric or duodenal surgery;
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Pfizer Investigational Site
Anaheim, California, 92801
Pfizer Investigational Site
Chesapeake, Virginia, 23320
Pfizer Investigational Site
Houston, Texas, 77074
Pfizer Investigational Site
Houston, Texas, 77090
Pfizer Investigational Site
Jupiter, Florida, 33458
Pfizer Investigational Site
New York, New York, 10021
Pfizer Investigational Site
Ocoee, Florida, 34761
Pfizer Investigational Site
Raleigh, North Carolina, 27607
Pfizer Investigational Site
Raleigh, North Carolina, 27612
Pfizer Investigational Site
San Diego, California, 92103-6204
Pfizer Investigational Site
South Miami, Florida, 33143
About this study
Official title: A Multicenter, Randomized, Placebo And Active-Controlled Study Of The Effect Of CJ-023,423 On The Incidence Gastroduodenal Endoscopic Ulcers In Healthy Subjects
CJ-023,423 is a new medication being developed as an anti-inflammatory agent for the treatment of the signs and symptoms of osteoarthritis (OA). The purpose of this study is to evaluate whether patients treated with CJ-023,423 for 7 days (14 doses) have fewer gastrointestinal ulcers compared to patients treated with naproxen and placebo.
- Conditions
- Osteoarthritis
- Being tested
- CJ-023,423, placebo, naproxen
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CJ-023,423Drug
75 mg BID
placeboDrug
placebo
naproxenDrug
naproxen
| Study group | Role | What they receive |
|---|---|---|
| 3 | Placebo comparator | Not described Receives: Drug: placebo |
| 1 | Experimental | 75 mg BID Receives: Drug: naproxen |
| 2 | Experimental | Not described Receives: Drug: CJ-023,423 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the presence of gastroduodenal ulcers in each subject, as determined by a UGI endoscopy at the end of the treatment
Measured: 7 days
Secondary outcomes (11)
Incidence of treatment-emergent, all-causality GI body system adverse events
Measured: Duration of trial
Severity of Dyspepsia Assessment (SODA)
Measured: Duration of trial
Post treatment gastric, duodenal and gastroduodenal endoscopic scores (according to the mucosal grading scale). The gastroduodenal score is defined as the higher of the gastric and duodenal scores.
Measured: Duration of trial
Incidence of any gastric ulcer
Measured: Duration of trial
Incidence of any duodenal ulcer
Measured: Duration of trial
Incidence of any gastroduodenal erosion or ulcer
Measured: Duration of trial
Incidence of any gastric erosion or ulcer
Measured: Duration of trial
Incidence of any duodenal erosion or ulcer
Measured: Duration of trial
Incidence of any esophageal ulcer using the traditional grading method of: normal, erosion or ulcer
Measured: Duration of trial
Incidence of any esophageal ulcer or erosion using the LA classification: esophageal ulcers and erosions method with a Grade A, B, C, or D)
Measured: Duration of trial
Number of gastroduodenal ulcers in each subject
Measured: Duration of trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2006 (estimated)
- Study startNov 2006
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00392080
- Sponsor's protocol ID
- A5231018
- Status last verified
- Mar 2008
- First submitted
- 23 Oct 2006
- Last updated
- 24 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Placebo And Active-Controlled Study Of The Effect Of CJ-023,423 On The Incidence Gastroduodenal Endoscopic Ulcers In Healthy Subjects
- ClinicalTrials.gov ID
- NCT00392080
- Acronym / sponsor ID
- A5231018
- Conditions
- Osteoarthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Study completion
- Feb 2008 (actual)
- First posted
- 25 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
CJ-023,423 is a new medication being developed as an anti-inflammatory agent for the treatment of the signs and symptoms of osteoarthritis (OA). The purpose of this study is to evaluate whether patients treated with CJ-023,423 for 7 days (14 doses) have fewer gastrointestinal ulcers compared to patients treated with naproxen and placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3 | Placebo comparator | Drug: placebo |
| 1 | Experimental | Drug: naproxen75 mg BID |
| 2 | Experimental | Drug: CJ-023,423 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Is a healthy adult 18 to 75 years of age, inclusive; healthy is defined as no clinically relevant abnormalities identified as detailed medical history, full physical examination, including blood pressure [BP] and pulse rate [PR]measurement, 12-lead electrocardiogram [ECG], and clinical safety laboratory tests
- If female and of childbearing potential (includes women who have been postmenopausal for < 2 years ), must be using adequate contraception, must not be lactating and must have had a negative serum pregnancy test at Screening and a negative urine pregnancy test result within 24 hours prior to receiving study drug. The site investigator must ensure that female subjects are not pregnant prior to receiving the first dose of drug;
Key exclusion criteria (2 listed)
- Endoscopic evidence of inflammation, ulceration, erosion, petechiae, or active bleeding in the esophagus, stomach, pyloric channel, or duodenum at the baseline/ randomization (Day 1) endoscopy (Mucosal Grading Scale score >0);
- Active GI disease (e.g. inflammatory bowel disease), a history of gastroduodenal ulcers or bleeding, or a history of any gastric or duodenal surgery;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CJ-023,42375 mg BID | Drug | 2 |
| placeboplacebo | Drug | 3 |
| naproxennaproxen | Drug | 1 |
Primary outcome
The primary endpoint is the presence of gastroduodenal ulcers in each subject, as determined by a UGI endoscopy at the end of the treatment
Time frame: 7 days
11 secondary outcomes
Incidence of treatment-emergent, all-causality GI body system adverse events
Time frame: Duration of trial
Severity of Dyspepsia Assessment (SODA)
Time frame: Duration of trial
Post treatment gastric, duodenal and gastroduodenal endoscopic scores (according to the mucosal grading scale). The gastroduodenal score is defined as the higher of the gastric and duodenal scores.
Time frame: Duration of trial
Incidence of any gastric ulcer
Time frame: Duration of trial
Incidence of any duodenal ulcer
Time frame: Duration of trial
Incidence of any gastroduodenal erosion or ulcer
Time frame: Duration of trial
Incidence of any gastric erosion or ulcer
Time frame: Duration of trial
Incidence of any duodenal erosion or ulcer
Time frame: Duration of trial
Incidence of any esophageal ulcer using the traditional grading method of: normal, erosion or ulcer
Time frame: Duration of trial
Incidence of any esophageal ulcer or erosion using the LA classification: esophageal ulcers and erosions method with a Grade A, B, C, or D)
Time frame: Duration of trial
Number of gastroduodenal ulcers in each subject
Time frame: Duration of trial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2008.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CJ-023,423 and naproxen in people with Osteoarthritis, run by Pfizer at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is the presence of gastroduodenal ulcers in each subject, as determined by a UGI endoscopy at the end of the treatment (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2008.