Clinical Trial: Japanese IP-TN Trial

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Open-label, Single-group, Multicentre, Phase III Study to Confirm the Efficacy and Safety of IP-TN When Administered for 2 Weeks to Patients With Low Back Pain, Scapulohumeral Pe

Brief Summary:

This is an open-label, single-group, multi-centre trial to confirm the safety and efficacy of loxoprofen sodium/methocarbamol ( IP-TN) when administered orally for 2 weeks to patients with low back pain, scapulohumeral periarthritis, or cervico-omo-brachial syndrome associated with muscle strain. More than 90 patients will be screened to enroll approximately 80 patients in the trial.

After giving written informed consent, patients will be enrolled in the trial. Patients who are considered eligible for the trial by the Investigator after consent and complete the trial procedures and assessments at Visit 1 will receive the trial medication and enter the open-label treatment period of 2 weeks. Patients who complete the open-label treatment period will enter the follow-up period of 1 week and complete the trial after confirmation at the last visit (or phone interview).

Detailed Summary:
Sponsor: Boehringer Ingelheim

Current Primary Outcome: The number (%) of patients with drug related Adverse Events [ Time Frame: up to 3 weeks ]

Original Primary Outcome: The number (%) of patients with drug related AEs [ Time Frame: up to 3 weeks ]

Current Secondary Outcome: Percentage of patients who showed "marked improvement" or "moderate improvement" in low back pain and/or scapulohumeral periarthritis and/or cervico-omo-brachial syndrome after 2 weeks of treatment [ Time Frame: 2 weeks ]

Original Secondary Outcome: Same as current

Information By: Boehringer Ingelheim

Dates:
Date Received: July 11, 2016
Date Started: July 2016
Date Completion:
Last Updated: December 2, 2016
Last Verified: December 2016