Hydrocodone Bitartrate and Acetaminophen Tablets, USP: Vicodin

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.

{m} Entries

Phase
Study Indication or Disease
Study Name
M12-169 AbbVie_IU_icons_outlined_v3 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 AbbVie_IU_icons_outlined_v3 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 AbbVie_IU_icons_outlined_v3 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 AbbVie_IU_icons_outlined_v3 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 AbbVie_IU_icons_outlined_v3 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 AbbVie_IU_icons_outlined_v3 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 AbbVie_IU_icons_outlined_v3 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 AbbVie_IU_icons_outlined_v3 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 AbbVie_IU_icons_outlined_v3 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 AbbVie_IU_icons_outlined_v3 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 AbbVie_IU_icons_outlined_v3 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 AbbVie_IU_icons_outlined_v3 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 AbbVie_IU_icons_outlined_v3 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