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

Acute Pain Clinical Trial

Official title:

A Phase 2 Randomized, Double-blind, Placebo-controlled, 3-arm, 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: NCT03206749
• Other study ID #: VX16-150-103
• Status: Completed
• Phase: Phase 2
• Start date: June 29, 2017
• Est. completion date: December 8, 2017

Study information

• Verified date: January 2021
• Source: Vertex Pharmaceuticals Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase 2 randomized, double-blind, placebo-controlled, 3-arm, parallel design study to evaluate the efficacy and safety of VX-150 in treating acute pain following bunionectomy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 243
• Est. completion date: December 8, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

Prior to Surgery:

• Body mass index (BMI) of 18.0 to 38.0 kg/m2, inclusive

• 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 =4 on the 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

Exclusion Criteria:

Prior to 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

• Intolerant of or unwilling to receive hydrocodone, acetaminophen, or ibuprofen

• For female subjects: Pregnant, nursing, or planning to become pregnant during the study or within 90 days after the last study drug dose

• For male subjects: Male subjects with a female partner who is pregnant, nursing, or planning to become pregnant during the study or within 90 days after the last study drug dose

After Surgery:

• Subject had a type 3 deformity requiring a base wedge osteotomy or concomitant surgery such as hammertoe repair; or experienced medical complications during the bunionectomy that, in the opinion of the investigator, should preclude randomization

Other protocol defined inclusion/exclusion criteria may apply.

Related Conditions & MeSH terms

• Acute Pain

Intervention

Drug:
• VX-150
Participants received VX-150 1500 milligram (mg) as first dose, followed by VX-150 750 mg dose every 12 hours (q12h) for 2 days.
• HB/APAP
Participants received HB 5 mg/APAP 325 mg every 6 hours (q6h) for 2 days.
• Placebo
Participants received placebo matched to VX-150 and HB/APAP for 2 days.

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials	Anaheim	California
United States	Lotus Clinical Research	Pasadena	California
United States	Arizona Research Center	Phoenix	Arizona
United States	Jean Brown Research	Salt Lake City	Utah

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 (SPID) Between VX-150 Versus Placebo as Recorded on a Numeric Pain Rating Scale (NPRS) 0 to 24 Hours After the 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 the first dose
Secondary	Time-weighted Sum of the Pain Intensity Difference Between VX-150 Versus Placebo as Recorded on a NPRS 2 to 24 Hours After the 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). SPID22 was calculated from 2 to 24 hours and the score range was -220 (worst score) to 220 (best score).	2 to 24 hours after the first dose
Secondary	Time-weighted Sum of the Pain Intensity Difference Between VX-150 Versus Placebo as Recorded on a NPRS 0 to 48 Hours After the 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 the first dose
Secondary	Time to Onset of Perceptible Pain Relief After the First Dose of VX-150 Versus Placebo	Time to onset of perceptible pain relief (any pain relief at all after the first dose) reported based on the first 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 second stopwatch assessment.	up to 6 hours after the first dose
Secondary	Time to First Rescue Medication After the First Dose of VX-150 Versus Placebo	Time to first rescue medication was the time elapsed from the first dose of VX-150 or placebo until the participants received the first dose of rescue medication.	up to 48 hours after the first dose
Secondary	Percentage of Participants Using Rescue Medication After the First Dose VX-150 Versus Placebo		0 to 24 hours after the first dose and 24 to 48 hours after the first dose
Secondary	Total Rescue Medication Used After the First Dose of VX-150 Versus Placebo	Total use of rescue medication was calculated as the sum of number of capsules multiplied by capsule strength at each dosing occasion of rescue medication. Rescue medication was ibuprofen (400 mg [oral] every 4 hours (q4h) as needed).	0 to 24 hours after the first dose and 24 to 48 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	Time to Reach Maximum Observed Plasma Concentration (Tmax) of VRT- 1207355 and VRT- 1268114		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 Adverse Events (AEs) and Serious Adverse Events (SAEs)		From Day 1 up to Day 10