Acute PainPhase 2NCT03206749
A Study to Evaluate Efficacy and Safety of VX-150 in Subjects With Acute Pain Following Bunionectomy
A Phase 2 study testing VX-150 and HB/APAP in people with Acute Pain, run by Vertex Pharmaceuticals Incorporated at 4 sites in United States.
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. 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 and HB/APAP
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 243 participants
- Where
- 4 sitesUnited States
- Study dates
- 29 Jun 2017to 8 Dec 2017
- 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
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Anaheim Clinical Trials
Anaheim, California, 92801
Lotus Clinical Research
Pasadena, California, 91105
Arizona Research Center
Phoenix, Arizona, 85023
Jean Brown Research
Salt Lake City, Utah, 84124
About this study
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
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.
- Conditions
- Acute Pain
- Being tested
- VX-150, HB/APAP, 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
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/APAPDrug
Participants received HB 5 mg/APAP 325 mg every 6 hours (q6h) for 2 days.
PlaceboDrug
Participants received placebo matched to VX-150 and HB/APAP for 2 days.
| Study group | Role | What they receive |
|---|---|---|
| VX-150 | Experimental | Not described Receives: Drug: VX-150 |
| Hydrocodone Bitartrate/Acetaminophen (HB/APAP) | Active comparator | Not described Receives: Drug: HB/APAP |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
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 (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).
Measured: 0 to 24 hours after the first dose
Secondary outcomes (11)
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).
Measured: 2 to 24 hours after the first dose
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).
Measured: 0 to 48 hours after the first dose
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.
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 second stopwatch assessment.
Measured: up to 6 hours after the first dose
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.
Measured: up to 48 hours after the first dose
Percentage of Participants Using Rescue Medication After the First Dose VX-150 Versus Placebo
Measured: 0 to 24 hours after the first dose and 24 to 48 hours after the first dose
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).
Measured: 0 to 24 hours after the first dose and 24 to 48 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
Time to Reach Maximum Observed Plasma Concentration (Tmax) of VRT- 1207355 and VRT- 1268114
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 Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: From 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.
- First posted2 Jul 2017
- Study start29 Jun 2017
- Primary completion1 Dec 2017
- Study completion8 Dec 2017
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03206749
- Sponsor's protocol ID
- VX16-150-103
- Status last verified
- Jan 2021
- First submitted
- 29 Jun 2017
- Last updated
- 3 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03206749
- Acronym / sponsor ID
- VX16-150-103
- Conditions
- Acute Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- Vertex Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2017 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 8 Dec 2017 (actual)
- First posted
- 2 Jul 2017 (actual)
- Results
- Posted 3 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VX-150 | Experimental | Drug: VX-150 |
| Hydrocodone Bitartrate/Acetaminophen (HB/APAP) | Active comparator | Drug: HB/APAP |
| Placebo | Placebo comparator | Drug: Placebo |
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 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
- 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
Key exclusion criteria (13 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-150Participants received VX-150 1500 milligram (mg) as first dose, followed by VX-150 750 mg dose every 12 hours (q12h) for 2 days. | Drug | VX-150 |
| HB/APAPParticipants received HB 5 mg/APAP 325 mg every 6 hours (q6h) for 2 days. | Drug | Hydrocodone Bitartrate/Acetaminophen (HB/APAP) |
| PlaceboParticipants received placebo matched to VX-150 and HB/APAP for 2 days. | Drug | Placebo |
Primary outcome
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
Time frame: 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).
11 secondary outcomes
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
Time frame: 2 to 24 hours after the first dose
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
Time frame: 0 to 48 hours after the first dose
Time to Onset of Perceptible Pain Relief After the 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
Time to First Rescue Medication After the First Dose of VX-150 Versus Placebo
Time frame: up to 48 hours after the first dose
Percentage of Participants Using Rescue Medication After the First Dose VX-150 Versus Placebo
Time frame: 0 to 24 hours after the first dose and 24 to 48 hours after the first dose
Total Rescue Medication Used After the First Dose of VX-150 Versus Placebo
Time frame: 0 to 24 hours after the first dose and 24 to 48 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
Time to Reach Maximum Observed Plasma Concentration (Tmax) of VRT- 1207355 and VRT- 1268114
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 Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From Day 1 up to Day 10
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- 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.
4 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 and HB/APAP in people with Acute Pain, run by Vertex Pharmaceuticals Incorporated at 4 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 13 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 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 3 Feb 2021). 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 (SPID) Between VX-150 Versus Placebo as Recorded on a Numeric Pain Rating Scale (NPRS) 0 to 24 Hours After the First Dose (time frame: 0 to 24 hours after the first dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Feb 2021.