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NCT01202799 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics, Bioavailability and Safety of PENNSAID® Gel
A Phase 1 study, sponsored by Mallinckrodt.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT01202799: Completed Phase 1 study, sponsored by Mallinckrodt.
NCT01202799 is a Phase 1 study that has completed, run by Mallinckrodt. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01202799, a Phase 1 study, has completed, sponsored by Mallinckrodt.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
It is anticipated that PENNSAID Gel will minimize systemic exposure versus oral diclofenac administered twice a day (BID). In addition, PENNSAID Gel should result in greater subject convenience and compliance with a comparable bioavailability, safety and tolerability profile to that of the approved PENNSAID solution administered four times a day (QID).
Primary Outcome
Summary statistics including the mean, standard deviation, coefficient of variation, geometric mean and geometric %CV will be calculated for all PK parameters by treatment.
Interventions
- DRUG 2% w/w diclofenac sodium topical gel
- DRUG 1.5% w/w diclofenac sodium topical solution
- DRUG 75 mg diclofenac sodium delayed release tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2010-09 |
| Est. Completion | 2010-11 |
| Phase | Phase 1 |
What the finished NCT01202799 record still lists
NCT01202799 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 3 interventions - of which 2% w/w diclofenac sodium topical gel is the first listed.
NCT01202799 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01202799 about?
NCT01202799 is a clinical study titled "Pharmacokinetics, Bioavailability and Safety of PENNSAID® Gel". It is anticipated that PENNSAID Gel will minimize systemic exposure versus oral diclofenac administered twice a day (BID). In addition, PENNSAID Gel should result in greater subject convenience and compliance with a comparable bioavailability, safety and tolerability profile to that of the approved ...
What is the current status of trial NCT01202799?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2010-09. Estimated completion is 2010-11.
What interventions are being tested in trial NCT01202799?
The interventions under investigation include: 2% w/w diclofenac sodium topical gel (DRUG), 1.5% w/w diclofenac sodium topical solution (DRUG), 75 mg diclofenac sodium delayed release tablet (DRUG).
Who is sponsoring clinical trial NCT01202799?
This trial is sponsored by Mallinckrodt, which has 69 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01202799's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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