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NCT00369928 · ClinicalTrials.gov registry record · Phase 2
Evaluation of 2 Oral Doses of PG-760564 in Rheumatoid Arthritis (RA) Patients Receiving Methotrexate
A Phase 2 study, sponsored by Procter and Gamble.
- Completed
- Registry status
- Phase 2
- Development phase
- 254
- Enrollment target
NCT00369928: Completed Phase 2 study, sponsored by Procter and Gamble.
NCT00369928 is a Phase 2 study that has completed, run by Procter and Gamble. The registered enrollment target is 254 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00369928, a Phase 2 study, has completed, sponsored by Procter and Gamble.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 254 participants
- Enrollment target
Study Summary
This will be a 12-week, double-blind, randomized, placebo-controlled, parallel group, multicenter study to evaluate the safety, efficacy, and PK of oral administration of PG-760564 in adult patients with active RA receiving treatment with MTX. Two oral doses of PG-760564 will be evaluated: 25 mg BID and 100 mg BID. The study will consist of a screening visit followed by a washout period for all disease modifying antirheumatic drugs (DMARDs) and anti-cytokine therapies except MTX. After the washout period, patients determined to be eligible will be randomized to receive either 25 mg BID or 100 mg BID of oral PG-760564, or placebo for 12 weeks. There will be 6 treatment visits and a follow-up visit 4 weeks after the last treatment visit. The primary efficacy endpoint will be the proportion of patients meeting the ACR 20 response criteria after 12 weeks of treatment.
Primary Outcome
percent, relative to baseline, of patients meeting the American College of Rheumatology 20 response criteria (ACR20) at 12weeks
Interventions
- DRUG PG-760564
- DRUG Placebo dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 254 participants |
| Start Date | 2006-08 |
| Est. Completion | 2008-01 |
| Phase | Phase 2 |
What the finished NCT00369928 record still lists
NCT00369928 is an interventional study that assigns participants to a tested intervention. The registered 254 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% higher).
The record links to 0 conditions, and to 2 interventions - of which PG-760564 is the first listed.
NCT00369928 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00369928 about?
NCT00369928 is a clinical study titled "Evaluation of 2 Oral Doses of PG-760564 in Rheumatoid Arthritis (RA) Patients Receiving Methotrexate". This will be a 12-week, double-blind, randomized, placebo-controlled, parallel group, multicenter study to evaluate the safety, efficacy, and PK of oral administration of PG-760564 in adult patients with active RA receiving treatment with MTX. Two oral doses of PG-760564 will be evaluated: 25 mg BID...
What is the current status of trial NCT00369928?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 254 participants. The study started on 2006-08. Estimated completion is 2008-01.
What interventions are being tested in trial NCT00369928?
The interventions under investigation include: PG-760564 (DRUG), Placebo dose (DRUG).
Who is sponsoring clinical trial NCT00369928?
This trial is sponsored by Procter and Gamble, which has 70 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00369928's enrollment target sits among peer trials
254 219th of 2000 higher than 1,781 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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