Minocycline for the Prevention of Post-operative Intercostal Neuralgia
This study is currently recruiting participants.
Verified February 2013 by University of Adelaide
Sponsor:
University of Adelaide
Information provided by (Responsible Party):
Prof Paul Rolan, University of Adelaide
ClinicalTrials.gov Identifier:
NCT01314482
First received: March 11, 2011
Last updated: February 4, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Post-operative Intercostal Neuralgia |
Drug: Minocycline |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | The Efficacy of Prophylactic Administration of Minocycline in Reducing Chronic Intercostal Neuralgia Post-thoracotomy |
Resource links provided by NLM:
Further study details as provided by University of Adelaide:
Primary Outcome Measures:
- Daily pain scores on a numerical rating scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Hypo/hyperaesthesia to punctate sensation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 116 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Minocycline |
Drug: Minocycline
200mg bd for 3 days before surgery
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01314482
Locations
| Australia, South Australia | |
| Royal Adelaide Hospital | Recruiting |
| Adelaide, South Australia, Australia, 5000 | |
| Contact: Melanie Gentgall, RN +61 8 82222712 melanie.gentgall@health.sa.gov.au | |
| Contact: James Swift, BHlthSci(Hons) +61 8 82222712 james.swift@adelaide.edu.au | |
| Principal Investigator: Craig Jurisevic, MD | |
| Sub-Investigator: Paul E Rolan, MD | |
Sponsors and Collaborators
University of Adelaide
More Information
No publications provided
| Responsible Party: | Prof Paul Rolan, Professor of Clinical Pharmacology, University of Adelaide |
| ClinicalTrials.gov Identifier: | NCT01314482 History of Changes |
| Other Study ID Numbers: | U1111-1119-6985 |
| Study First Received: | March 11, 2011 |
| Last Updated: | February 4, 2013 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
Keywords provided by University of Adelaide:
|
Neuropathic pain Minocycline |
Additional relevant MeSH terms:
|
Neuralgia Pain Neurologic Manifestations Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases |
Signs and Symptoms Minocycline Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013