Acute PainPhase 2NCT03764072

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

A Phase 2 study testing VX-150 in people with Acute Pain, run by Vertex Pharmaceuticals Incorporated at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Acute Pain
What is being tested?: VX-150
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 250 participants
Where: 6 sitesUnited States
Study dates: 12 Dec 2018to 25 Jan 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 11Show fewer

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

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Anaheim Clinical Trials
Anaheim, California, 92801
Lotus Clinical Research
Pasadena, California, 91105
Chesapeake Research Group
Pasadena, Maryland, 21122
Arizona Research Center
Phoenix, Arizona, 85053
JBR Clinical Research
Salt Lake City, Utah, 84107
Endeavor Clinical Trials
San Antonio, Texas, 78229

Other trials in United States

About this study

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

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

Conditions: Acute Pain
Being tested: VX-150, Placebo
Medical subject headings: Acute Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VX-150Drug
Capsules for oral administration.
PlaceboDrug
Capsules for oral administration.

Study groups in NCT03764072
Study group	Role	What they receive
Placebo	Placebo comparator	Participants received placebo matched to VX-150 for 2 days. Receives: Drug: Placebo
VX-150 - Dose Level 1	Experimental	Participants received VX-150 1500 milligrams (mg) as first dose, followed by VX-150 750 mg every 12 hours (q12h) for 2 days. Receives: Drug: VX-150
VX-150 - Dose Level 2	Experimental	Participants received VX-150 1000 mg once daily (qd) for 2 days. Receives: Drug: VX-150
VX-150 - Dose Level 3	Experimental	Participants received VX-150 500 mg q12h for 2 days. Receives: Drug: VX-150
VX-150 - Dose Level 4	Experimental	Participants received VX-150 500 mg as first dose, followed by VX-150 250 mg q12h for 2 days. Receives: Drug: VX-150
VX-150 - Dose Level 5	Experimental	Participants received VX-150 250 mg qd for 2 days. Receives: Drug: VX-150

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 0 to 24 Hours After First Dose

Secondary outcomes (9)

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).
Measured: 0 to 48 Hours After First Dose
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.
Measured: From Baseline at 24 Hours After First Dose
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.
Measured: From Baseline at 24 Hours After First Dose
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.
Measured: From Baseline at 24 Hours After First Dose
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.
Measured: Up to 6 hours After the First Dose
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.
Measured: Up to 6 Hours After the First Dose
Maximum Observed Concentration (Cmax) of VRT- 1207355 (Active Moiety) and VRT- 1268114 (Metabolite M5)
Measured: Day 1 and Day 2
Area Under the Concentration Versus Time Curve From 0 to 12 Hours (AUC0-12h) of VRT- 1207355 and VRT- 1268114
Measured: Day 1 and Day 2
Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Day 1 up to Day 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Dec 201825 Jan 2019

First posted4 Dec 2018
Study start12 Dec 2018
Primary completion17 Jan 2019
Study completion25 Jan 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acute PainStudies of the same condition, open and under way.
More trials run by Vertex Pharmaceuticals IncorporatedThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 250 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03764072
Sponsor's protocol ID: VX18-150-104
Status last verified: Jan 2022
First submitted: 3 Dec 2018
Last updated: 9 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acute Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03764072
Acronym / sponsor ID: VX18-150-104
Conditions: Acute Pain
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 250 participants (actual)
Lead sponsor: Vertex Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
Study start: 12 Dec 2018 (actual)
Primary completion: 17 Jan 2019 (actual)
Study completion: 25 Jan 2019 (actual)
First posted: 4 Dec 2018 (actual)
Results: Posted 9 Feb 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboParticipants received placebo matched to VX-150 for 2 days.
VX-150 - Dose Level 1	Experimental	Drug: VX-150Participants received VX-150 1500 milligrams (mg) as first dose, followed by VX-150 750 mg every 12 hours (q12h) for 2 days.
VX-150 - Dose Level 2	Experimental	Drug: VX-150Participants received VX-150 1000 mg once daily (qd) for 2 days.
VX-150 - Dose Level 3	Experimental	Drug: VX-150Participants received VX-150 500 mg q12h for 2 days.
VX-150 - Dose Level 4	Experimental	Drug: VX-150Participants received VX-150 500 mg as first dose, followed by VX-150 250 mg q12h for 2 days.
VX-150 - Dose Level 5	Experimental	Drug: VX-150Participants received VX-150 250 mg qd for 2 days.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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
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 (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VX-150Capsules for oral administration.	Drug	VX-150 - Dose Level 1, VX-150 - Dose Level 2, VX-150 - Dose Level 3, VX-150 - Dose Level 4, VX-150 - Dose Level 5
PlaceboCapsules for oral administration.	Drug	Placebo

Primary outcome

Time-weighted Sum of the Pain Intensity Difference as Recorded on Numeric Pain Rating Scale (NPRS) 0 to 24 Hours (SPID24) After First Dose
Time frame: 0 to 24 Hours 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).

9 secondary outcomes

Time-weighted Sum of Pain Intensity Difference as Recorded on NPRS 0 to 48 Hours (SPID48) After First Dose
Time frame: 0 to 48 Hours After First Dose
Proportion of Participants With at Least 30 Percent (%) Reduction in NPRS at 24 Hours After First Dose of VX-150 Versus Placebo
Time frame: From Baseline at 24 Hours After First Dose
Proportion of Participants With at Least 50% Reduction in NPRS at 24 Hours After the First Dose of VX-150 Versus Placebo
Time frame: From Baseline at 24 Hours After First Dose
Proportion of Participants With at Least 70% Reduction in NPRS at 24 Hours After the First Dose of VX-150 Versus Placebo
Time frame: From Baseline at 24 Hours After First Dose
Time to Onset of Confirmed Perceptible Pain Relief After First Dose of VX-150 Versus Placebo
Time frame: Up to 6 hours After the First Dose
Time to Onset of Meaningful Pain Relief After the First Dose of VX-150 Versus Placebo
Time frame: Up to 6 Hours After the First Dose
Maximum Observed Concentration (Cmax) of VRT- 1207355 (Active Moiety) and VRT- 1268114 (Metabolite M5)
Time frame: Day 1 and Day 2
Area Under the Concentration Versus Time Curve From 0 to 12 Hours (AUC0-12h) of VRT- 1207355 and VRT- 1268114
Time frame: Day 1 and Day 2
Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Day 1 up to Day 10

Results and safety

Results posted to the registry on 9 Feb 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	46	46
VX-150 - Dose Level 1	42	42
VX-150 - Dose Level 2	44	43
VX-150 - Dose Level 3	45	45
VX-150 - Dose Level 4	46	45
VX-150 - Dose Level 5	27	26

Primary outcome: Time-weighted Sum of the Pain Intensity Difference as Recorded on Numeric Pain Rating Scale (NPRS) 0 to 24 Hours (SPID24) After First Dose

Time frame: 0 to 24 Hours After First Dose. Mean (Standard Deviation). Unit: units on a scale

Measure	Placebo n = 46	VX-150 - Dose Level 1 n = 42	VX-150 - Dose Level 2 n = 44	VX-150 - Dose Level 3 n = 45	VX-150 - Dose Level 4 n = 46	VX-150 - Dose Level 5 n = 27
Value	19.1 (49.7)	37.3 (45.6)	32.3 (51.2)	30.5 (46.9)	27.5 (37.8)	28.3 (43.6)

Placebo vs VX-150 - Dose Level 1 vs VX-150 - Dose Level 2 vs VX-150 - Dose Level 3 vs VX-150 - Dose Level 4 vs VX-150 - Dose Level 5: p = 0.2107, Multiple Comparison Procedure-Modelling
Placebo vs VX-150 - Dose Level 1 vs VX-150 - Dose Level 2 vs VX-150 - Dose Level 3 vs VX-150 - Dose Level 4 vs VX-150 - Dose Level 5: p = 0.0766, Multiple Comparison Procedure-Modelling
Placebo vs VX-150 - Dose Level 1 vs VX-150 - Dose Level 2 vs VX-150 - Dose Level 3 vs VX-150 - Dose Level 4 vs VX-150 - Dose Level 5: p = 0.0989, Multiple Comparison Procedure-Modelling

Population analysed: Full analysis set (FAS) included all randomized participants who received at least 1 dose of study drug.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 up to Day 10. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 46 (0%)	7 of 46 (15.2%)	0 of 46
VX-150 - Dose Level 1	0 of 42 (0%)	9 of 42 (21.4%)	0 of 42
VX-150 - Dose Level 2	0 of 44 (0%)	13 of 44 (29.5%)	0 of 44
VX-150 - Dose Level 3	0 of 45 (0%)	12 of 45 (26.7%)	0 of 45
VX-150 - Dose Level 4	0 of 46 (0%)	12 of 46 (26.1%)	0 of 46
VX-150 - Dose Level 5	1 of 27 (3.7%)	4 of 27 (14.8%)	0 of 27

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VX-150 in people with Acute Pain, run by Vertex Pharmaceuticals Incorporated at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time-weighted Sum of the Pain Intensity Difference as Recorded on Numeric Pain Rating Scale (NPRS) 0 to 24 Hours (SPID24) After First Dose (time frame: 0 to 24 Hours After First Dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03764072.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2022.