Japanese IP-TN Trial

Phase 3

Completed

• Conditions: Pain
• Interventions: Drug: Loxoprofen sodium; Drug: Methocarbamol

• Registration Number: NCT02831569
• Lead Sponsor: Boehringer Ingelheim

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 Description

Not available

Study Timeline

• Study First Submitted: 2016-07-11
• Study First Submitted QC: 2016-07-11
• Study First Posted: 2016-07-13
• Study Start: 2016-07-27
• Primary Completion: 2016-10-19
• Study Completion: 2016-10-19
• Status Verified: 2017-10
• Results First Submitted: 2017-10-05
• Results First Submitted QC: 2017-10-05
• Last Update Submitted: 2017-10-05
• Results First Posted: 2018-07-20
• Last Update Posted: 2018-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Loxoprofen sodium/methocarbamol FDC	Loxoprofen sodium	fixed dose combination (FDC) tablets
Loxoprofen sodium/methocarbamol FDC	Methocarbamol	fixed dose combination (FDC) tablets

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With Drug-related Adverse Events [AEs]	Up to 3 weeks.	The outcome measure presents percentage of patients with drug-related AEs.

Secondary Outcome Measures

Name	Time	Method
Assessment of Pain Due to Low Back Pain, Scapulohumeral Periarthritis or Cervico-omo-brachial Syndrome After 2 Weeks of Treatment	Post 2 weeks.	The outcome measure presents 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.

Trial Locations

Locations (3)

Shinjuku Res. Park Clinic, Tokyo, I.M.; 🇯🇵 Tokyo, Shinjyuku-ku, Japan

Fukuwa Clinic; 🇯🇵 Tokyo, Chuo-ku, Japan

Tokyo-Eki Center-building Clinic; 🇯🇵 Tokyo, Chuo-ku, Japan