NTM-001 Treatment Arm for Postoperative Pain

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Postoperative PainKetorolac Tromethamine - Drug
Eligibility
18 - 64
All Sexes
What conditions do you have?
Select

Study Summary

This clinical study is a randomized, double-blind, double-dummy, parallel group, multi-center, active and placebo-controlled trial evaluating the analgesic efficacy and safety of NTM-001 in subjects with moderately severe postoperative pain after bunionectomy surgery. This study is designed to compare the efficacy of NTM-001 to placebo. Intravenous (IV) morphine serves as an active comparator to determine assay sensitivity and support assessment of opioid-level analgesia for NTM-001. Effectiveness, safety, and tolerability parameters will be descriptively compared between treatment arms.

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 0 to 24 hours after start of administration

Hour 24
Summed Pain Intensity Difference (SPID24)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

3 Treatment Groups

Morphine Treatment Arm
1 of 3
NTM-001 Treatment Arm
1 of 3
Placebo Treatment Arm
1 of 3

Active Control

Experimental Treatment

Non-Treatment Group

360 Total Participants · 3 Treatment Groups

Primary Treatment: NTM-001 Treatment Arm · Has Placebo Group · Phase 3

NTM-001 Treatment ArmExperimental Group · 2 Interventions: Ketorolac Tromethamine, IV Placebo for Morphine · Intervention Types: Drug, Other
Morphine Treatment ArmActiveComparator Group · 2 Interventions: Morphine Sulfate, Intravenous Placebo for NTM-001 · Intervention Types: Drug, Other
Placebo Treatment ArmPlaceboComparator Group · 2 Interventions: IV Placebo for Morphine, Intravenous Placebo for NTM-001 · Intervention Types: Other, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketorolac Tromethamine
2007
Completed Phase 4
~1340

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 0 to 24 hours after start of administration

Who is running the clinical trial?

NEMA Research, Inc.Lead Sponsor
15 Previous Clinical Trials
40,883 Total Patients Enrolled

Eligibility Criteria

Age 18 - 64 · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have no physical status rating of ≥ 3 on the ASA rating scale.
You are scheduled to undergo primary unilateral first metatarsal bunionectomy.
You are postmenopausal, surgically sterile, abstinent, or practicing or agree to practice an effective method of birth control if you are sexually active before entry, throughout the study, and for 7 days after the last dose of study drug
You are willing and able to complete all study procedures including training on pain scales, follow instructions, communicate meaningfully with study personnel, and return for all visits as listed in the protocol.
You have given written informed consent prior to any study-related procedure being performed.
You are between 18 and 65 years of age at the time of consent.