Pentoxifylline and Lumbar Radiculopathy | NCT03060434

Studies
Pentoxifylline and Lumbar Radiculopathy

NCT03060434

Sponsor

St Joseph University, Beirut, Lebanon

Status

Active, not recruiting

Last Update Posted

May 21, 2025Actual

Enrollment

67Actual

Phase

Phase 4

Conditions

Lumbar Radiculopathy
Lumbar Disc Herniation
Lumbar Disc Disease

Interventions

Pentoxifylline Oral Tablet
Ibuprofen

Countries

Lebanon

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2018Actual

Primary Completion Date

Dec 1, 2022Actual

Completion Date

Dec 1, 2026Estimated

First Submitted Date

Feb 18, 2017

First Submission Date that Met QC Criteria

Feb 18, 2017

First Posted Date

Feb 23, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 18, 2025

Last Update Posted Date

May 21, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr Joseph Maarrawi, Associate Professor : Researcher - Pain Specialist - Neurosurgeon, St Joseph University, Beirut, LebanonPrincipal Investigator

Lead Sponsor

St Joseph University, Beirut, LebanonOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objective of this prospective controlled crossover study is to evaluate the efficacy and safety of pentoxifylline per os (800 mg daily) in the management of lumbar radiculopathy

Detailed Description

Patients with lumbar radiculopathy, are recruited from senior author clinic. After verification of inclusion and exclusion criteria, patients consenting to enter the study are given 2 sequences (order randomly assigned) of treatment: Ibuprofen 600 mg bid, with paracetamol 1000 mg tid, pregabalin 75 mg bid for 15 days with pentoxifylline and 15 days without it. Basic clinical and demographical data are noted. Lumbar MRI results are also noted. Clinical evaluation of the patient is performed and included: clinical examination (including motor exam of lower limbs); pain is assessed according to Numerical rating Scale (NRS), and relative percentage of global improvement.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

67Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	Active Comparator	Ibuprofen	Drug: Ibuprofen
Pentoxifylline	Experimental	Pentoxifylline oral tablets	Drug: Pentoxifylline Oral Tablet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pentoxifylline Oral Tablet	Drug	patient will receive for 15 days: Ibuprofen 600 mg bid; pregabalin 75 mg bid; paracetamol 1 g tid; pentoxifylline 400 mg bid	Pentoxifylline

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Numerical rating scale (NRS)	Pain assessment by NRS	At day 15 (and Day 30)

Secondary Outcomes

Measure	Description	Time Frame
Patient global impression of improvement scale	pain improvement scale from 1 to 7	day 15 and 30
Side effects	Reporting side effects by patient

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Unilateral lumbar radiculopathy
Disc hernia confirming the diagnosis with radio-clinical concordance

Exclusion Criteria:

Radicular deficit needing surgery
Cauda equine syndrome
Absence of radio-clinical concordance on MRI
Contraindication for anti-inflammatory (Hypertension, renal insufficiency, gastric ulcer …)
Previous intolerance to pentoxifylline, and/or to pregabalin and/or paracetamol
Pregnancy
Follow-up not possible
Hepatic dysfunction
History of drug abuse
Current use of tramadol, codeine and/or morphine and its derivative
Antidepressant use

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joseph Maarrawi, MD, PhD	Hotel Dieu de France Hospital - Beirut, Lebanon, 16 6830	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hotel Dieu de France Hospital		Beirut		16 6830	Lebanon

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011843	Radiculopathy
D007405	Intervertebral Disc Displacement
C535531	Intervertebral disc disease
D012585	Sciatica

Ancestor Terms

ID	Term
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D013122	Spinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010431	Pentoxifylline
D007052	Ibuprofen
D000082	Acetaminophen
D000069583	Pregabalin

Ancestor Terms

ID	Term
D013805	Theobromine
D014970	Xanthines
D011688	Purinones
D011687	Purines
D006574

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

Each patient will receive for 1 month: Ibuprofen 600 mg bid; Paracetamol 1g tid if needed; pregabalin 75 mg bid pentoxifylline 400 mg bid will be added for either the first or second 15 days (randomization)