NCT06629402Phase 2Completed

Assessment of PF614 Effects on Experimental Pain in the Cold Pressure Test (PF614-201)

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2023-11-14Actual

Enrollment · participants16Actual

Source updated2024-10-08Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Acute Pain

Treatments or interventions studied

PF614DrugAlso known as Oxycodone prodrug
PlaceboDrugAlso known as Control

Primary outcomes · main study measures

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measure: Change from Baseline (pre-dose) in Time to Pain Onset (defined as time to first pain); description: The time to first pain was recorded by trained site staff using a stop watch. Each subject was instructed to remove their hand at 3 minutes if they had not yet reached pain tolerance. Separate assessments were made at pre-dose (within 60 minutes prior to dosing; at least duplicate measurements, 30 minutes apart) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, and 6 hours post-dose.; timeFrame: 6 hours; measure: Change from Baseline in Pain Tolerance (defined as latency time required for removal of hand from water bath); description: The latency time to hand removal from the water bath was recorded by trained site staff using a separate stopwatch. Separate assessments were made at pre-dose (within 60 minutes prior to dosing; at least duplicate measurements, 30 minutes apart) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, and 6 hours post-dose.; timeFrame: 6 hours

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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