Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ultracet · 1 trial · 1 indication
Baseline measurements of participant-specific knee PI were gathered pre-dose on Day 1 from the briskest possible self-pace constant walks on a treadmill over the course of a 20 minute interval. Over this interval PI readings were taken at time points 0,3,6,9,12,15,18 and 20 minutes, rated on an 11-point numeric rating scale (NRS), with 0: No Pain - 10: Worst Pain You Can Imagine. Following a single treatment on Day 3, PI was similarly measured over 20 minute self paced walks at 4 and 6 hrs post-dose. The difference between the TWA (0-20 minutes) PI determined at baseline, and the average of the two TWA (0-20 minutes) PI from the self-paced walks on Day 3 is reported as units on a scale.
| Arm | Type | Description |
|---|---|---|
| Placebo, Naproxen, Ultracet | EXPERIMENTAL | Participants were treated with Placebo for 3 days in Treatment Period 1, Naproxen for 3 days in Treatment Period 2, and Ultracet for 3 days in Treatment Period 3. The treatment periods were separated by a 4-6 day break. |
| Naproxen, Ultracet, Placebo | EXPERIMENTAL | Participants were treated with Naproxen for 3 days in Treatment Period 1, Ultracet for 3 days in Treatment Period 2, and Placebo for 3 days in Treatment Period 3. The treatment periods were separated by a 4-6 day break. |
| Ultracet, Placebo, Naproxen | EXPERIMENTAL | Participants were treated with Ultracet for 3 days in Treatment Period 1, Placebo for 3 days in Treatment Period 2, and Naproxen for 3 days in Treatment Period 3. The treatment periods were separated by a 4-6 day break. |
| Placebo, Ultracet, Naproxen | EXPERIMENTAL | Participants were treated with Placebo for 3 days in Treatment Period 1, Ultracet for 3 days in Treatment Period 2, and Naproxen for 3 days in Treatment Period 3. The treatment periods were separated by a 4-6 day break. |
| Naproxen, Placebo, Ultracet | EXPERIMENTAL | Participants were treated with Naproxen for 3 days in Treatment Period 1, Placebo for 3 days in Treatment Period 2, and Ultracet for 3 days in Treatment Period 3. The treatment periods were separated by a 4-6 day break. |
| Ultracet, Naproxen, Placebo | EXPERIMENTAL | Participants were treated with Ultracet for 3 days in Treatment Period 1, Naproxen for 3 days in Treatment Period 2, and Placebo for 3 days in Treatment Period 3. The treatment periods were separated by a 4-6 day break. |
| Name | Type | Description |
|---|---|---|
| Naproxen | DRUG | Naproxen tablets 500 mg twice daily on Day 1, a first dose at t = 0 hrs, and a second dose at t = 12 hrs. Twice daily on Day 2 and 500 mg once daily on Day 3. Walking tests will be performed on Days 1 and 3 of the treatment period. |
| Placebo | DRUG | Placebo capsules twice daily on Day 1, a first dose at t = 0 hrs, and a second dose at t = 12 hrs. Three times daily on Day 2, and 2 capsules on the morning of Day 3. Walking tests will be performed on Days 1 and 3 of the treatment period. |
| Ultracet | DRUG | Ultracet (tramadol/acetaminophen) 37.5/325 mg/mg capsules twice daily on Day 1, a first dose at t = 0 hrs, and a second dose at t = 12 hrs. Three times daily on Day 2, and two 37.5/325 mg capsules on the morning of Day 3. Walking tests will be performed on Days 1 and 3 of the treatment period. |
Inclusion Criteria: * Has osteoarthritis of the knee and primary source of pain is knee * Females must not be pregnant or nursing and must agree to use birth control throughout the study * Is willing to limit alcohol and caffeine intake * Is willing to abstain from smoking during study visits * Mus...
Ultracet is an investigational small molecule being studied for the treatment of osteoarthritis. It is being developed by Merck & Company, Inc. (MRK) and is currently in Phase 1 clinical development.
Ultracet is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK.
Ultracet is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed.
Ultracet has one completed Phase 1 clinical trial, identified as NCT00772967. This trial evaluated the effect of analgesics on a walking model of knee pain in patients with osteoarthritis and enrolled 22 participants.
Ultracet is the drug name used in clinical development. No alternative names have been reported for this investigational therapy.