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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 is a Phase 2 study that has completed, run by Procter and Gamble. The registered enrollment target is 254 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00369928
The ClinicalTrials.gov registry entry for NCT00369928 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 254 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Procter and Gamble, which has 70 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which PG-760564 is the first listed.
NCT00369928 reports 0 study locations.
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.
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