Trial Outcomes & Findings for Japanese IP-TN Trial (NCT NCT02831569)
NCT ID: NCT02831569
Last Updated: 2018-07-20
Results Overview
The outcome measure presents percentage of patients with drug-related AEs.
COMPLETED
PHASE3
80 participants
Up to 3 weeks.
2018-07-20
Participant Flow
Participant milestones
| Measure |
Loxoprofen Sodium/Methocarbamol [FDC]
The subjects were administered 2 Loxoprofen sodium/methocarbamol combination \[Fixed Dose Combination (FDC)\] film-coated tablets orally 3 times daily after each meal for 2 weeks.
Each 2 tablets contained Loxoprofen sodium hydrate 68.1 mg and methocarbamol 500 mg.
|
|---|---|
|
Overall Study
STARTED
|
80
|
|
Overall Study
COMPLETED
|
80
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Japanese IP-TN Trial
Baseline characteristics by cohort
| Measure |
Loxoprofen Sodium/Methocarbamol [FDC]
n=80 Participants
The subjects were administered 2 Loxoprofen sodium/methocarbamol combination \[Fixed Dose Combination (FDC)\] film-coated tablets orally 3 times daily after each meal for 2 weeks.
Each 2 tablets contained Loxoprofen sodium hydrate 68.1 mg and methocarbamol 500 mg.
|
|---|---|
|
Age, Continuous
|
50.8 Years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 3 weeks.Population: Treated Set \[TS\]: The analysis set included patients who received at least one dose of the trial medication during the trial period. Safety analysis was performed on TS.
The outcome measure presents percentage of patients with drug-related AEs.
Outcome measures
| Measure |
Loxoprofen Sodium/Methocarbamol [FDC]
n=80 Participants
The subjects were administered 2 Loxoprofen sodium/methocarbamol combination \[Fixed Dose Combination (FDC)\] film-coated tablets orally 3 times daily after each meal for 2 weeks.
Each 2 tablets contained Loxoprofen sodium hydrate 68.1 mg and methocarbamol 500 mg.
|
|---|---|
|
Percentage of Patients With Drug-related Adverse Events [AEs]
|
7.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Post 2 weeks.Population: Full Analysis Set \[FAS\]: The analysis set included patients who received at least one dose of the trial medication during the trial period and have efficacy data at baseline and after the start of treatment. Efficacy analysis was performed on FAS.
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.
Outcome measures
| Measure |
Loxoprofen Sodium/Methocarbamol [FDC]
n=80 Participants
The subjects were administered 2 Loxoprofen sodium/methocarbamol combination \[Fixed Dose Combination (FDC)\] film-coated tablets orally 3 times daily after each meal for 2 weeks.
Each 2 tablets contained Loxoprofen sodium hydrate 68.1 mg and methocarbamol 500 mg.
|
|---|---|
|
Assessment of Pain Due to Low Back Pain, Scapulohumeral Periarthritis or Cervico-omo-brachial Syndrome After 2 Weeks of Treatment
|
37.5 Percentage of participants
|
Adverse Events
Loxoprofen Sodium/Methocarbamol [FDC]
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER