Post-operative Intercostal NeuralgiaPhase 2NCT01314482
Minocycline for the Prevention of Post-operative Intercostal Neuralgia
A Phase 2 study testing Minocycline in people with Post-operative Intercostal Neuralgia, run by University of Adelaide at 1 site in Australia.
Trial summary
In about half the patients who have an open chest surgery there is persistent severe pain in the chest. The investigators are examining whether minocycline, a commonly used antibiotic, will prevent pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-operative Intercostal Neuralgia
- What is being tested?
- Minocycline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteAustralia
- Study dates
- Nov 2010to Feb 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female
- Aged 18 years or older
- Undertaking elective, open thoracotomy with ample time pre-operatively to provide informed consent and undertake dosing
- Sufficient fluency in English language to read and understand consent form, fulfil study requirements and communicate with research staff
- Negative pregnancy test at screening for women of child bearing potential
- Females of child bearing potential must agree to use a medically acceptable method of contraception other than oral contraceptives from time of first dosing until one week post-operatively. Acceptable methods include abstinence, contraceptive patches, NuvaRing (etonogestrel/ethinyl oestradiol vaginal ring), diaphragm with vaginal spermicide, intrauterine device, condom and vaginal spermicide, progestin implant or injection
- Avoid prolonged, direct sunlight or ultra-violet light exposure during dosing period
- Refrain from strenuous activities and avoid changes to regular exercise patterns throughout trial period
Who cannot join
- Pregnant or breast feeding
- Known allergy to minocycline and other tetracycline antibiotics
- Pre-existing neuralgic pain condition in area designated for operation
- Physical abnormality in area designated for operation
- Taking disallowed concomitant medication
- Renal insufficiency as determined by a calculated creatinine clearance of < 60mL/min
Show all 12Show fewer
- Hepatic dysfunction as determined by alanine transaminase and/or aspartate transaminase in excess of three times upper normal limits
- Diagnosis of systemic lupus erythematosus
- Recent diagnosis of enterocolitis or colitis
- Participation in another trial of an investigational product within 30 days of commencing dosing or are scheduled to commence trial of an investigational product during study period
- Patients who, in an Investigator's opinion, should not participate in the trial or may not be capable of following the trial schedule for any reason
- History of major psychiatric disorder not medically controlled
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Melanie Gentgall, RN, +61 8 82222712, melanie.gentgall@health.sa.gov.au
James Swift, BHlthSci(Hons), +61 8 82222712, james.swift@adelaide.edu.au
About this study
Official title: The Efficacy of Prophylactic Administration of Minocycline in Reducing Chronic Intercostal Neuralgia Post-thoracotomy
In about half the patients who have an open chest surgery there is persistent severe pain in the chest. The investigators are examining whether minocycline, a commonly used antibiotic, will prevent pain. Minocycline blocks the activity of immune cells which the investigators believe are responsible for prolonging the pain.
Read the detailed description
The study is of double-blind placebo controlled parallel groups design in up to 116 patients undergoing elective open thoracotomy. Minocycline 200mg twice daily or matching placebo are given three days before surgery.
- Conditions
- Post-operative Intercostal Neuralgia
- Being tested
- Minocycline
- Keywords
- Neuropathic pain, Minocycline
- Medical subject headings
- Neuralgia, cyclopia sequence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MinocyclineDrug
200mg bd for 3 days before surgery
| Study group | Role | What they receive |
|---|---|---|
| Minocycline | Experimental | Not described Receives: Drug: Minocycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily pain scores on a numerical rating scale
Measured: 3 months
Secondary outcomes (1)
Hypo/hyperaesthesia to punctate sensation
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2011 (estimated)
- Study startNov 2010
- Primary completionDec 2013 (estimated)
- Study completionFeb 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative Intercostal NeuralgiaStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Adelaide
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Paul Rolan, University of Adelaide
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01314482
- Sponsor's protocol ID
- U1111-1119-6985
- Status last verified
- Feb 2013
- First submitted
- 11 Mar 2011
- Last updated
- 6 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Prophylactic Administration of Minocycline in Reducing Chronic Intercostal Neuralgia Post-thoracotomy
- ClinicalTrials.gov ID
- NCT01314482
- Acronym / sponsor ID
- U1111-1119-6985
- Conditions
- Post-operative Intercostal Neuralgia
- Keywords
- Neuropathic pain, Minocycline
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- University of AdelaideUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 14 Mar 2011 (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.
In about half the patients who have an open chest surgery there is persistent severe pain in the chest. The investigators are examining whether minocycline, a commonly used antibiotic, will prevent pain. Minocycline blocks the activity of immune cells which the investigators believe are responsible for prolonging the pain.
Detailed description
The study is of double-blind placebo controlled parallel groups design in up to 116 patients undergoing elective open thoracotomy. Minocycline 200mg twice daily or matching placebo are given three days before surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Minocycline | Experimental | Drug: Minocycline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female
- Aged 18 years or older
- Undertaking elective, open thoracotomy with ample time pre-operatively to provide informed consent and undertake dosing
- Sufficient fluency in English language to read and understand consent form, fulfil study requirements and communicate with research staff
- Negative pregnancy test at screening for women of child bearing potential
Key exclusion criteria (12 listed)
- Pregnant or breast feeding
- Known allergy to minocycline and other tetracycline antibiotics
- Pre-existing neuralgic pain condition in area designated for operation
- Physical abnormality in area designated for operation
- Taking disallowed concomitant medication
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 |
|---|---|---|
| Minocycline200mg bd for 3 days before surgery | Drug | Minocycline |
Primary outcome
Daily pain scores on a numerical rating scale
Time frame: 3 months
1 secondary outcome
Hypo/hyperaesthesia to punctate sensation
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2013.
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Recruiting
SPS Block vs. Surgical Intercostal Block for Chronic Pain After Thoracoscopic Surgery
Chronic Post-thoracotomy Pain, Neuropathic Pain
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.
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 Minocycline in people with Post-operative Intercostal Neuralgia, run by University of Adelaide at 1 site in Australia.
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 8 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 6 Feb 2013. 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 Australia. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily pain scores on a numerical rating scale (time frame: 3 months). 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 6 Feb 2013.