CSR Synopses following approval of a new medicine or a new indication for an approved medicine in the US or EU. We are making CSR synopses available to supplement the public information available to patients and healthcare providers about the results of our clinical trials and the evidence used to approve a new medicine or a new indication.
Hydrocodone Bitartrate and Acetaminophen Tablets, USP: Vicodin
| Study Name | |||
|---|---|---|---|
| M12-169 | Acute Pain | Phase 2 | A Randomized, Multicenter Study Comparing the Analgesic Efficacy and Safety of Hydrocodone / Acetaminophen Extended Release to Placebo in Subjects With Acute Pain Following Bunionectomy |
| M10-277 | Chronic Pain | Phase 3 | A Phase 3, Open-Label Period Followed by a Randomized, Double-Blind Placebo-Controlled Study of the Analgesic Efficacy of Extended-Release Hydrocodone/Acetaminophen (Vicodin CR) Compared to Placebo in Subjects with Chronic Low Back Pain |
| M03-643 | Other | Phase 2 | A Randomized, Multi-center, Double-blind Study Comparing the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen and Placebo in Subjects With Osteoarthritis |
| M05-772 | Acute Pain | Phase 2 | A Randomized, Multicenter, Single-blind Study Comparing the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR) and Immediate Release Hydrocodone/Acetaminophen (NORCO®) to Placebo in Subjects With Acute Pain Following Bunionectomy |
| M11-063 | Acute Pain | Phase 2 | A Randomized, Multicenter, Single-Blind, Placebo-Controlled Study Comparing the Analgesic Efficacy and Safety of Hydrocodone/ Acetaminophen Extended-Release Tablets and Hydrocodone/Acetaminophen (NORCO) to Placebo in Subjects with Acute Pain Following Third Molar Tooth Extraction |
| M04-697 | Other | Phase 3 | A Phase 3, Randomized, Multicenter, Double-blind Study Comparing the Analgesic Efficacy of Extended Release Hydrocodone/Acetaminophen Tablets (Vicodin CR) to Placebo in Subjects With Osteoarthritis |
| M12-058 | Acute Pain | Phase 2 | A Randomized, Multicenter, Single-Blind Study Comparing Hydrocodone/Acetaminophen Extended Release 10/650, Morphine Extended Release, and Acetaminophen to Placebo in Subjects with Acute Pain Following Bunionectomy |
| M05-790 | Chronic Pain | Phase 3 | A Phase 3, Open-Label Period Followed by a Randomized, Double-Blind, Placebo-Controlled Study of the Analgesic Efficacy and Safety of Extended-Release Hydrocodone/Acetaminophen (Vicodin CR) Compared to Placebo in Subjects with Chronic Low Back Pain |
| M03-666 | Other | Phase 3 | An Open-Label Study Evaluating the Safety and Tolerability of Long Term Administration of Hydrocodone/Acetaminophen Extended ReleaseTablets (Vicodin® CR) in Subjects With Moderate to Severe Chronic, Non-Malignant Pain |
| M10-385 | Chronic Pain | Phase 3 | A Phase 3, Open-Label Period Followed by a Randomized, Double-Blind, Placebo-Controlled Study of the Analgesic Efficacy of Extended-Release Hydrocodone/Acetaminophen (Vicodin CR) Compared to Placebo in Subjects with Chronic Low Back Pain |
| M12-807 | Chronic Pain | Phase 2 | A Phase 2, Randomized Withdrawal Study of the Analgesic Efficacy and Safety of Hydrocodone/Acetaminophen Extended Release Compared to Placebo in Subjects with Chronic Low Back Pain |
| M10-421 | Acute Pain | Phase 3 | A Randomized, Multicenter, Double-Blind Study Comparing the Analgesic Efficacy and Safety of Immediate Release Hydrocodone/Acetaminophen to Placebo in Subjects with Acute Pain Following Bunionectomy |
| M05-765 | Acute Pain | Phase 3 | A Randomized, Multicenter, Double-blind Study Comparing the Analgesic Efficacy and Safety of Extended-Release Hydrocodone/Acetaminophen (Vicodin CR®) to Placebo in Subjects With Acute Pain Following Bunionectomy |