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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01314482




Registration number
NCT01314482
Ethics application status
Date submitted
11/03/2011
Date registered
14/03/2011
Date last updated
6/02/2013

Titles & IDs
Public title
Minocycline for the Prevention of Post-operative Intercostal Neuralgia
Scientific title
The Efficacy of Prophylactic Administration of Minocycline in Reducing Chronic Intercostal Neuralgia Post-thoracotomy
Secondary ID [1] 0 0
U1111-1119-6985
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-operative Intercostal Neuralgia 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Minocycline

Experimental: Minocycline -


Treatment: Drugs: Minocycline
200mg bd for 3 days before surgery
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Daily pain scores on a numerical rating scale
Timepoint [1] 0 0
3 months
Secondary outcome [1] 0 0
Hypo/hyperaesthesia to punctate sensation
Timepoint [1] 0 0
3 months

Eligibility
Key inclusion criteria
- 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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

- 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2014
Actual
Sample size
Target
116
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
University of Adelaide
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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. Minocycline blocks the activity of immune cells which the investigators
believe are responsible for prolonging the pain.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01314482
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01314482