Acute PainPhase 2NCT03246971
Study of Wafermine™ for Post-bunionectomy or Abdominoplasty Pain
A Phase 2 study testing Wafermine™ 50 mg, Wafermine™ 75 mg and Wafermine™ 25 mg in people with Acute Pain and Bunion, run by iX Biopharma Ltd. at 1 site in United States.
Trial summary
This study evaluates the safety and effectiveness of Wafermine™ for post-bunionectomy or post-abdominoplasty pain over a 24 hours period. For subjects undergoing bunionectomy, 2 out of 3 subjects will receive Wafermine™ and 1 out of 3 subjects will receive placebo. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Pain, Bunion, Abdominoplasty
- What is being tested?
- Wafermine™ 50 mg, Wafermine™ 75 mg and Wafermine™ 25 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2017to 17 Jul 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Scheduled for a bunionectomy or mini abdominoplasty with no additional planned procedures.
- Good general health without clinically significant renal, hepatic, cardiac or respiratory disease, as determined by the Investigator.
Who cannot join
- For those undergoing bunionectomy, other painful conditions involving the surgical foot.
- Positive lab values for Hepatitis B or C or HIV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2, Multiple-Dose Study of The Efficacy and Safety of Wafermine™ (Sublingual Ketamine) in Participants Experiencing Acute Post-Operative Bunionectomy or Abdominoplasty Pain
This study evaluates the safety and effectiveness of Wafermine™ for post-bunionectomy or post-abdominoplasty pain over a 24 hours period. For subjects undergoing bunionectomy, 2 out of 3 subjects will receive Wafermine™ and 1 out of 3 subjects will receive placebo. For subjects undergoing abdominoplasty, 3 out of 4 subjects will receive Wafermine™ and 1 out of 4 subjects will receive placebo.
- Conditions
- Acute Pain, Bunion, Abdominoplasty
- Being tested
- Wafermine™ 50 mg, Wafermine™ 75 mg, Placebos, Wafermine™ 25 mg
- Medical subject headings
- Acute Pain, Bunion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wafermine™ 50 mgDrug
Administered as needed for 12 hours
Wafermine™ 75 mgDrug
Administered as needed for 12 hours
PlacebosDrug
Administered as needed for 12 hours
Wafermine™ 25 mgDrug
Administered as needed for 12 hours
| Study group | Role | What they receive |
|---|---|---|
| Wafermine™ | Experimental | Not described Receives: Drug: Wafermine™ 50 mg; Drug: Wafermine™ 75 mg; Drug: Wafermine™ 25 mg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Summed Pain Intensity Differences (SPID) using a Numerical Rating Scale
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study start24 Aug 2017
- Primary completion12 Jul 2018
- Study completion17 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- 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
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- iX Biopharma Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03246971
- Sponsor's protocol ID
- KET010
- Status last verified
- Jul 2018
- First submitted
- 8 Aug 2017
- Last updated
- 23 Jul 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multiple-Dose Study of The Efficacy and Safety of Wafermine™ (Sublingual Ketamine) in Participants Experiencing Acute Post-Operative Bunionectomy or Abdominoplasty Pain
- ClinicalTrials.gov ID
- NCT03246971
- Acronym / sponsor ID
- KET010
- Conditions
- Acute Pain, Bunion, Abdominoplasty
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- iX Biopharma Ltd.University, hospital or other
- Study start
- 24 Aug 2017 (actual)
- Primary completion
- 12 Jul 2018 (actual)
- Study completion
- 17 Jul 2018 (actual)
- First posted
- 11 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the safety and effectiveness of Wafermine™ for post-bunionectomy or post-abdominoplasty pain over a 24 hours period. For subjects undergoing bunionectomy, 2 out of 3 subjects will receive Wafermine™ and 1 out of 3 subjects will receive placebo. For subjects undergoing abdominoplasty, 3 out of 4 subjects will receive Wafermine™ and 1 out of 4 subjects will receive placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wafermine™ | Experimental | Drug: Wafermine™ 50 mg, Drug: Wafermine™ 75 mg, Drug: Wafermine™ 25 mg |
| Placebo | Placebo comparator | Drug: Placebos |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Scheduled for a bunionectomy or mini abdominoplasty with no additional planned procedures.
- Good general health without clinically significant renal, hepatic, cardiac or respiratory disease, as determined by the Investigator.
Key exclusion criteria (2 listed)
- For those undergoing bunionectomy, other painful conditions involving the surgical foot.
- Positive lab values for Hepatitis B or C or HIV
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 |
|---|---|---|
| Wafermine™ 50 mgAdministered as needed for 12 hours | Drug | Wafermine™ |
| Wafermine™ 75 mgAdministered as needed for 12 hours | Drug | Wafermine™ |
| PlacebosAdministered as needed for 12 hours | Drug | Placebo |
| Wafermine™ 25 mgAdministered as needed for 12 hours | Drug | Wafermine™ |
Primary outcome
Summed Pain Intensity Differences (SPID) using a Numerical Rating Scale
Time frame: 12 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2018.
Related trials for Acute Pain
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruitingPhase 2
A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
Pain Management
Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Wafermine™ 50 mg, Wafermine™ 75 mg and Wafermine™ 25 mg in people with Acute Pain and Bunion, run by iX Biopharma Ltd. at 1 site 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 2 inclusion and 2 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 23 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Summed Pain Intensity Differences (SPID) using a Numerical Rating Scale (time frame: 12 hours). 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 23 Jul 2018.