Minocycline for the Prevention of Post-operative Intercostal Neuralgia

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University of Adelaide
Sponsor:
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

March 11, 2011
February 4, 2013
November 2010
December 2013   (final data collection date for primary outcome measure)
Daily pain scores on a numerical rating scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01314482 on ClinicalTrials.gov Archive Site
Hypo/hyperaesthesia to punctate sensation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Minocycline for the Prevention of Post-operative Intercostal Neuralgia
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Post-operative Intercostal Neuralgia
Drug: Minocycline
200mg bd for 3 days before surgery
Experimental: Minocycline
Intervention: Drug: Minocycline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
116
February 2014
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Australia
 
NCT01314482
U1111-1119-6985
No
Prof Paul Rolan, University of Adelaide
University of Adelaide
Not Provided
Not Provided
University of Adelaide
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP