Postoperative PainPhase 1TQTNCT00485667
Phase 1 Thorough QT Study in Young Healthy Volunteers
A Phase 1 study testing SKY0402 and Moxifloxacin 400mg in people with Postoperative Pain, run by Pacira Pharmaceuticals, Inc at 1 site in United Kingdom.
Trial summary
A reduction in the postoperative need for opioids to enhance the recovery process and increase patient postoperative satisfaction. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- SKY0402 and Moxifloxacin 400mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2007to Aug 2007
- Phase
- Phase 1
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult Caucasian men or non-pregnant, non-lactating women between 18 and 40 years of age, inclusive.
- Healthy as judged by responsible physician with no clinically significant abnormality identified on the medical and laboratory evaluation, including 12-lead ECG and vital signs.
- Non-smoker in the previous 3 months.
- Body weight greater than or equal to 50 kg and BMI within the range 19-29 kg/m2, inclusive.
- At screening and Run-in period each ECG should have:
- Consistent sinus rhythm, (i.e. if greater than or equal to 2 ECGs are not sinusal at different time points the volunteer should not be included),
Show all 30Show fewer
- No clinically significant conduction disorder,
- PR between 120 and 230 ms,
- HR less than or equal to 100 beats/min and greater than or equal to 40 beats/min,
- QRS < 120 ms,
- QT intervals that can be consistently analysed,
- QTcB less than or equal to 430 ms for males,
- QTcB less than or equal to 450 ms for females
- If there are outlying values in the ECGs, the consistency of these values should be confirmed as follows:
- If HR is between 40 and 44 bpm (inclusive) in 2 ECGs (of one triplicate) on more than one time point during Run-in, subject should not be selected. Conversely, this means that if HR is between 40 and 44 bpm at screening and/or on just one time-point-triplicate during Run-in, the volunteer can be selected.
- If HR < 40 bpm on a single occasion at screening or in Run-in period, subject should not be selected,
- If PR interval is consistently out-of-range (< 120 or > 230 ms) during Run-in period, i.e. in 2 out of 3 ECGs at one time point or in one ECG at more than one time point, the cardiologist needs to perform a manual measurement of this value. If the manual measurement confirms that PR is out-of-range, the volunteer must not be selected.
- If QRS is consistently >120 ms during run-in period, i.e. in 2 ECGs of a triplicate or in 2 ECGs from 2 different time-points, the cardiologist needs to perform a manual measurement of this value. If the manual measurement confirms the QRS is out-of-range, the volunteer must not be selected.
- If QTcB is out of range (QTcB >430 ms for males or >450 ms for females, or repeated demonstration of a QTcB interval >440 ms for females) even on a single occasion, it should be checked whether the heart rate is constant. If the HR is not constant and if the increase in QTcB is clearly due to hysteresis (e.g. on the immediate repeated ECG with consistent HR the QTcB is back to normal), then the volunteer can be selected. If the HR is constant and the QTcB is still out-of-range, the cardiologist needs to perform a manual measurement and calculation of the QTcB. If the QTcB is normal on manual measurement, the volunteer can be selected. If the QTcB is abnormal on manual measurement without acceptable cause, the volunteer must not be selected, even if the QTcB is outlying on one single ECG.
- The final decision to include / not include a volunteer based on protocol ECG criteria lies with the cardiologist assessing the Run-in ECGs.
- Signed and dated written informed consent prior to admission to the study.
- The subject is able to understand and comply with protocol requirements, instructions, and protocol-stated restrictions.
- A female subject may be entered into the study if she is:
- Post-menopausal female defined as being amenorrhoeic for greater than 2 years with an appropriate clinical profile, e.g. appropriate age and history of vasomotor symptoms. However; if indicated, this should be confirmed by estradiol and FSH levels consistent with menopause (according to local laboratory ranges).
- Pre-menopausal females with a documented hysterectomy (medical report verification) and/or bilateral oophorectomy. In the case of oophorectomy alone, only acceptable when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
- Females of childbearing potential must use one of the following methods of contraception:
- Abstinence
- Surgical sterilisation (tubal ligation)
- use oral contraceptives, injectable progesterone, or subdermal implants
- use double barrier method consisting of spermicide in addition to using a condom, or having another form of contraception such as an intrauterine device, diaphragm, or cervical cap.
Who cannot join
- History or presence of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease.
- History of clinically significant syncope.
- Family history of sudden death.
- Family history of premature cardiovascular death.
- Clinically significant history or family history of congenital long QT syndrome (e.g. Romano-Ward syndrome, Jervell and Lange-Nielson syndrome) or Brugada's syndrome.
- History of clinically significant arrhythmias (especially ventricular arrhythmias, atrial fibrillation, or recent conversion from atrial fibrillation).
Show all 31Show fewer
- Complete bundle branch block / sinus node dysfunction.
- Conditions predisposing the volunteer to electrolyte imbalances (e.g. altered nutritional states, chronic vomiting, anorexia nervosa, bulimia nervosa).
- Any pathology or abnormality with possible influence on the ECGs.
- Clinically significant dermatological disease including history of drug-induced skin rash.
- History of clinically significant psychiatric illness.
- History of gastro-intestinal surgery except appendectomy, herniotomy and cholecystectomy.
- History of chronic inflammation of gastro-intestinal tract.
- History of tendinopathy with fluoroquinolone.
- Subjects with vital signs measurements as follows:
- Supine heart rate outside the 40 to 100 beats/min range,
- Standing heart rate outside the 40 to 125 beats/min range,
- Supine systolic blood pressure outside the 80 to 140 mmHg range
- Supine diastolic blood pressure outside the 40 to 95 mmHg range.
- Subjects with a symptomatic drop in systolic blood pressure of > 20 mmHg and diastolic > 10 mmHg at screening.
- A positive pre-study HIV 1 \& 2 antibodies, Hepatitis B surface antigen, and/or Hepatitis C antibody result.
- Positive serum pregnancy tests for women of childbearing potential.
- Subjects with a confirmed positive pre-study urine drugs of abuse / alcohol breath test.
- History or evidence of drug or alcohol abuse within 18 months of study start.
- Abuse of alcohol defined for males as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units; or for females defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units. One unit is equivalent to a half-pint(220 mL) of beer or 1 (25 ml) measure of spirits or 1 glass (125 ml) of wine.
- Use of prescribed medication during the two weeks before the baseline ECG day in Period 1 and use of OTC drugs (including herbal remedies and minerals) in the week before the baseline ECG day in Period 1 (or 14 days if the drug has enzyme affecting properties), unless in the opinion of the Investigator and Sponsor the medication will not interfere with the study procedures or compromise subject safety. Use of medications which are known to carry a risk of causing Torsades de Pointes is not allowed within 14 days or 10 times the elimination half life (whichever is longer) before the baseline ECG day in Period 1. Use of vitamins is not allowed within 48 hours before the baseline ECG day in Period 1. Oral contraceptive drugs for women of childbearing potential and occasional use of paracetamol (up to 2 g/day) for pain and fever relief is allowed.
- History or presence of allergy to the study drugs or drugs in their respective classes, or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation.
- A known history of hypersensitivity to drugs, specifically to any component of the study medication, or history of hypersensitivity to moxifloxacin or any member of the quinolone class of antimicrobial agents.
- The subject has eaten grapefruit, grapefruit juice, Seville oranges, watercress, broccoli, brussel sprouts or cabbage within seven days before the baseline ECG day in Period 1.
- Participation in a study with an investigational drug within 90 days prior to the baseline ECG day in Period 1.
- Blood donation or blood loss within 90 days prior to the baseline ECG day in Period 1.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effects of Therapeutic and Supra-therapeutic Single Doses of SKY0402 Given as Subcutaneous Injection on the QT/QTc Interval in Young Healthy Volunteers. A Prospective, Randomized, Placebo- and Positive-controlled, Double Blind, Single-centre, Crossover Phase 1 Study.
A reduction in the postoperative need for opioids to enhance the recovery process and increase patient postoperative satisfaction.
Read the detailed description
Providing extended pain relief without the use of indwelling catheters is the basis for developing SKY0402. A formulation of bupivacaine, given as a single injection after surgery, that could provide adequate, continuous, and extended pain relief would greatly simplify postoperative pain management, reduce the need for repeated administration, and minimize break-through episodes of pain.
- Conditions
- Postoperative Pain
- Being tested
- SKY0402, Moxifloxacin 400mg, Placebo injection, Placebo tablet
- Keywords
- pain, postoperative
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKY0402Drug
Subects received either 300mg or 450mg
Moxifloxacin 400mgDrug
Placebo injectionDrug
Placebo tabletDrug
| Study group | Role | What they receive |
|---|---|---|
| Moxifloxacin tablet | Active comparator | Not described Receives: Drug: SKY0402; Drug: Moxifloxacin 400mg; Drug: Placebo injection |
| Placebo tablet | Experimental | Not described Receives: Drug: SKY0402; Drug: Placebo injection; Drug: Placebo tablet |
| SKY0402 300mg | Experimental | Not described Receives: Drug: SKY0402; Drug: Moxifloxacin 400mg; Drug: Placebo tablet |
| SKY0402 450mg | Experimental | Not described Receives: Drug: SKY0402; Drug: Moxifloxacin 400mg; Drug: Placebo tablet |
| Placebo injection | Placebo comparator | Not described Receives: Drug: Moxifloxacin 400mg; Drug: Placebo injection; Drug: Placebo tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
ECG findings using the best heart rate correction method
Measured: Up to 96 hours
Secondary outcomes (1)
QT/QTc interval data variations from baseline
Measured: up to 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacira Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Richmond Pharmacology Limited
- Investigators
- Jorg Taubel, MD MFPM, Principal investigator, Richmond Pharmacology Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00485667
- Sponsor's protocol ID
- SKY0402C105
- Other IDs
- Richmond No. C07027, EudraCT Number: 2007-001981-33
- Acronym
- TQT
- Status last verified
- Feb 2021
- First submitted
- 11 Jun 2007
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Therapeutic and Supra-therapeutic Single Doses of SKY0402 Given as Subcutaneous Injection on the QT/QTc Interval in Young Healthy Volunteers. A Prospective, Randomized, Placebo- and Positive-controlled, Double Blind, Single-centre, Crossover Phase 1 Study.
- ClinicalTrials.gov ID
- NCT00485667
- Acronym / sponsor ID
- TQT / SKY0402C105
- Conditions
- Postoperative Pain
- Keywords
- pain, postoperative
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Collaborators
- Richmond Pharmacology Limited
- Study start
- Jun 2007
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 13 Jun 2007 (estimated)
- 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.
A reduction in the postoperative need for opioids to enhance the recovery process and increase patient postoperative satisfaction.
Detailed description
Providing extended pain relief without the use of indwelling catheters is the basis for developing SKY0402. A formulation of bupivacaine, given as a single injection after surgery, that could provide adequate, continuous, and extended pain relief would greatly simplify postoperative pain management, reduce the need for repeated administration, and minimize break-through episodes of pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Moxifloxacin tablet | Active comparator | Drug: SKY0402, Drug: Moxifloxacin 400mg, Drug: Placebo injection |
| Placebo tablet | Experimental | Drug: SKY0402, Drug: Placebo injection, Drug: Placebo tablet |
| SKY0402 300mg | Experimental | Drug: SKY0402, Drug: Moxifloxacin 400mg, Drug: Placebo tablet |
| SKY0402 450mg | Experimental | Drug: SKY0402, Drug: Moxifloxacin 400mg, Drug: Placebo tablet |
| Placebo injection | Placebo comparator | Drug: Moxifloxacin 400mg, Drug: Placebo injection, Drug: Placebo tablet |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (30 listed)
- Healthy adult Caucasian men or non-pregnant, non-lactating women between 18 and 40 years of age, inclusive.
- Healthy as judged by responsible physician with no clinically significant abnormality identified on the medical and laboratory evaluation, including 12-lead ECG and vital signs.
- Non-smoker in the previous 3 months.
- Body weight greater than or equal to 50 kg and BMI within the range 19-29 kg/m2, inclusive.
- At screening and Run-in period each ECG should have:
Key exclusion criteria (31 listed)
- History or presence of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease.
- History of clinically significant syncope.
- Family history of sudden death.
- Family history of premature cardiovascular death.
- Clinically significant history or family history of congenital long QT syndrome (e.g. Romano-Ward syndrome, Jervell and Lange-Nielson syndrome) or Brugada's syndrome.
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 |
|---|---|---|
| SKY0402Subects received either 300mg or 450mg | Drug | Moxifloxacin tablet, Placebo tablet, SKY0402 300mg, SKY0402 450mg |
| Moxifloxacin 400mg | Drug | Moxifloxacin tablet, Placebo injection, SKY0402 300mg, SKY0402 450mg |
| Placebo injection | Drug | Moxifloxacin tablet, Placebo injection, Placebo tablet |
| Placebo tablet | Drug | Placebo injection, Placebo tablet, SKY0402 300mg, SKY0402 450mg |
Primary outcome
ECG findings using the best heart rate correction method
Time frame: Up to 96 hours
1 secondary outcome
QT/QTc interval data variations from baseline
Time frame: up to 96 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 16 Feb 2021.
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
Jorg Taubel, MD MFPM principal investigator
Richmond Pharmacology Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SKY0402 and Moxifloxacin 400mg in people with Postoperative Pain, run by Pacira Pharmaceuticals, Inc at 1 site in United Kingdom.
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 30 inclusion and 31 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 16 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 1 site in United Kingdom. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
ECG findings using the best heart rate correction method (time frame: Up to 96 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 16 Feb 2021; AzTrials last refreshed its copy on 6 Nov 2026.