A Dose-ranging Study to Evaluate Efficacy and Safety of VX-150 in Subjects With Acute Pain Following Bunionectomy

Acute Pain Clinical Trial

Official title:

A Phase 2B Randomized, Double-blind, Placebo-controlled, Dose-ranging, Parallel-design Study of the Efficacy and Safety of VX-150 for Acute Pain Following Bunionectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03764072
• Other study ID #: VX18-150-104
• Status: Completed
• Phase: Phase 2
• Start date: December 12, 2018
• Est. completion date: January 25, 2019

Study information

• Verified date: January 2022
• Source: Vertex Pharmaceuticals Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the dose-response relationship and safety of VX-150 in treating acute pain following bunionectomy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: January 25, 2019
• Est. primary completion date: January 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Key Inclusion Criteria:

Before surgery:

• Body mass index (BMI) of 18.0 to 38.0 kilogram per meter square (kg/m^2)

• Be scheduled to undergo a primary unilateral first metatarsal bunionectomy repair, without collateral procedures, under regional anesthesia (Mayo and popliteal sciatic block) not to include base wedge procedure

After surgery:

• Subject reported pain of greater than or equal to (>=) 4 on Numeric Pain Rating Scale (NPRS) and moderate or severe pain on the Verbal Categorical Rating Scale (VRS) within 9 hours after removal of the popliteal sciatic block on Day 1

• Subject is lucid and able to follow commands

• All analgesic guidelines were followed during and after the bunionectomy

Key Exclusion Criteria:

Before surgery:

• History in the past 10 years of malignancy, except for squamous cell skin cancer, basal cell skin cancer, and Stage 0 cervical carcinoma in situ

• History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)

• History of abnormal laboratory results >=2.5*upper limit of normal (ULN)

• History of peripheral neuropathy

• A known or clinically suspected infection with human immunodeficiency virus or hepatitis B or C viruses

• Prior medical history of bunionectomy or other foot surgery on the index foot

• History of peptic ulcer disease, or intolerance or unwillingness to receive ibuprofen

After surgery:

• Subject had a type 3 deformity requiring a base wedge osteotomy or concomitant surgery

Other protocol defined inclusion/exclusion criteria may apply

Related Conditions & MeSH terms

• Acute Pain

Intervention

Drug:
• VX-150
Capsules for oral administration.
• Placebo
Capsules for oral administration.

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials	Anaheim	California
United States	Chesapeake Research Group	Pasadena	Maryland
United States	Lotus Clinical Research	Pasadena	California
United States	Arizona Research Center	Phoenix	Arizona
United States	JBR Clinical Research	Salt Lake City	Utah
United States	Endeavor Clinical Trials	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time-weighted Sum of the Pain Intensity Difference as Recorded on Numeric Pain Rating Scale (NPRS) 0 to 24 Hours (SPID24) After First Dose	SPID was calculated as the sum of the product of time (in hours) elapsed since previous measurements and pain intensity difference. Pain intensity difference was calculated by subtracting the pain intensity score at given post-dose time points from the baseline pain intensity scores (using pain rating score range: 0= no pain to 10= worst possible pain). SPID24 was calculated from 0 to 24 hours and the score range was -240 (worst score) to 240 (best score).	0 to 24 Hours After First Dose
Secondary	Time-weighted Sum of Pain Intensity Difference as Recorded on NPRS 0 to 48 Hours (SPID48) After First Dose	SPID was calculated as the sum of the product of time (in hours) elapsed since previous measurements and pain intensity difference. Pain intensity difference was calculated by subtracting the pain intensity score at given post-dose time points from the baseline pain intensity scores (using pain rating score range: 0= no pain to 10= worst possible pain). SPID48 was calculated from 0 to 48 hours and the score range was -480 (worst score) to 480 (best score).	0 to 48 Hours After First Dose
Secondary	Proportion of Participants With at Least 30 Percent (%) Reduction in NPRS at 24 Hours After First Dose of VX-150 Versus Placebo	Pain intensity was recorded on 11-point ordinal NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain. The percentage of participants with at least 30% reduction from baseline in NPRS at 24 hours after the first dose of VX-150 or placebo were reported.	From Baseline at 24 Hours After First Dose
Secondary	Proportion of Participants With at Least 50% Reduction in NPRS at 24 Hours After the First Dose of VX-150 Versus Placebo	Pain intensity was recorded on 11-point ordinal NPRS, score range: 0 to 10, where 0=no pain and 10=worst imaginable pain. The percentage of participants with at least 50% reduction from baseline in NPRS at 24 hours after the first dose of VX-150 or placebo were reported.	From Baseline at 24 Hours After First Dose
Secondary	Proportion of Participants With at Least 70% Reduction in NPRS at 24 Hours After the First Dose of VX-150 Versus Placebo	Pain intensity was recorded on 11-point ordinal NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain. The percentage of participants with at least 70% reduction from baseline in NPRS at 24 hours after the first dose of VX-150 or placebo were reported.	From Baseline at 24 Hours After First Dose
Secondary	Time to Onset of Confirmed Perceptible Pain Relief After First Dose of VX-150 Versus Placebo	Time to onset of confirmed perceptible pain relief (time to onset of perceptible pain relief [any pain relief at all after the first dose] for participants who had meaningful pain relief [relief that is meaningful to participants after the first dose] reported based on the stopwatch assessment.	Up to 6 hours After the First Dose
Secondary	Time to Onset of Meaningful Pain Relief After the First Dose of VX-150 Versus Placebo	Time to onset of meaningful pain relief (relief that is meaningful to participants after the first dose) reported based on the stopwatch assessment.	Up to 6 Hours After the First Dose
Secondary	Maximum Observed Concentration (Cmax) of VRT- 1207355 (Active Moiety) and VRT- 1268114 (Metabolite M5)		Day 1 and Day 2
Secondary	Area Under the Concentration Versus Time Curve From 0 to 12 Hours (AUC0-12h) of VRT- 1207355 and VRT- 1268114		Day 1 and Day 2
Secondary	Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)		Day 1 up to Day 10