NCT02051296

Brief Summary

The investigators are looking at whether peri-operative minocycline will reduce the duration of pain after minor hand surgery: carpal tunnel release and trigger finger release. The investigators' hypothesis is that minocycline will reduce post-operative pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
131

participants targeted

Target at P50-P75 for phase_2 chronic-pain

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 31, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

June 11, 2018

Completed
Last Updated

June 11, 2018

Status Verified

May 1, 2018

Enrollment Period

2.2 years

First QC Date

January 26, 2014

Results QC Date

November 23, 2016

Last Update Submit

May 10, 2018

Conditions

Chronic PainPost-operative Pain

Outcome Measures

Primary Outcomes (1)

  • Time to Pain Resolution

    the time until patient answers no pain at surgical site for three consecutive days

    up to 365 days

Study Arms (2)

minocycline

EXPERIMENTAL

perioperative minocycline for 5 days, starting 2 hours prior to surgery then 100mg BID

Drug: Minocycline

Placebo

PLACEBO COMPARATOR

PLacebo

Drug: placebo

Interventions

MinocyclineDRUG

RCT blinded placebo trial

Also known as: Minocycline Hydrochloride
minocycline
placeboDRUG

RCT blinded placebo trial

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult, Veteran,

You may not qualify if:

  • Kidney failure, Liver failure, thrombocytopenia, ALS, SLE, Frailty, unable to understand survery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Palo Alto VA

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Chronic PainPain, Postoperative

Interventions

Minocycline

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Results Point of Contact

Title
Dr Catherine Curtin
Organization
VA HCS Palo Alto
ccurtin@stanford.edu
650-493-5000

Study Officials

  • Catherine Curtin, MD

    Palo Alto Veterans Hsopital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Physician

Study Record Dates

First Submitted

January 26, 2014

First Posted

January 31, 2014

Study Start

January 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

June 11, 2018

Results First Posted

June 11, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)