Pain Clinical Trial
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 Periarthritis, or Cervico-omo-brachial Syndrome Associated With Muscle Strain
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).
n/a
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