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THEOPHYLLINE ANHYDROUS

THEOPHYLLINE ANHYDROUS has been studied in different clinical trial settings. One trial tested oral theophylline tablets for treating post-dural puncture headache (a severe headache that can happen after spinal anesthesia or an accidental puncture during epidural anesthesia). Another study used intravenous theophylline anhydrous as part of a heart imaging evaluation in people with chronic total coronary artery occlusion (a long-lasting complete blockage of a heart artery). This article explains what these trials looked at, how the drug was given, and what outcomes were measured.

Table of Contents

What THEOPHYLLINE ANHYDROUS is in these trials

In the provided clinical trial records, the drug appears as an oral tablet used to treat headache after a dural puncture and as an intravenous solution for injection used in a cardiovascular imaging study.[1][2]

One listed “other name” (synonym/brand name) for the oral tablet is Quibron-T/SR tablets.[1]

The cardiovascular study lists synonyms for the active substance such as ANHYDROUS THEOPHYLLINE and “THEOPHYLLINE (ANHYDROUS).”[2]

Clinical trial in post-dural puncture headache (PDPH)

This study asked whether oral theophylline is more effective than oral sumatriptan for treating PDPH.[1]

The trial describes PDPH as a frequent complication after procedures involving dural puncture for spinal anesthesia or after accidental dural puncture during epidural anesthesia.[1]

It was a prospective, randomized, double-blind, phase four clinical trial that included 60 patients with PDPH, split into two equal groups of 30 patients each.[1]

The theophylline group received an oral theophylline tablet at 150 mg every 12 hours.[1]

The comparator group received oral sumatriptan succinate at 25 mg every 12 hours.[1]

What outcomes were measured in the PDPH trial

The main outcome was pain severity measured with the Numeric Pain Rating Scale (NPRS), which is an 11-point scale from 0 to 10 where 0 means no pain and 10 means the worst possible pain.[1]

Pain scores were collected before treatment and then at 2, 6, 12, 18, and 24 hours, then every 12 hours until 48 hours after starting treatment.[1]

The trial planned to report NPRS results as both median (range) and mean ± standard deviation over the 48-hour timeframe.[1]

A secondary outcome was the duration of PDPH (in hours), defined as the time from headache onset until the NPRS score became 3 or less.[1]

Another secondary outcome was the length of hospital stay (in days), measured from hospital admission until discharge, over the same 48-hour evaluation period.[1]

Side effects monitored in the PDPH trial

The study tracked the number and rate of treatment-related side effects within 48 hours after starting treatment.[1]

Side effects listed for monitoring included palpitations (feeling of fast or irregular heartbeat), dizziness, gastric irritation (stomach irritation), nausea/vomiting, diarrhea, warm sensations in the body, tingling sensation, and tightness in the chest, throat, neck, or jaws.[1]

Clinical study in chronic total coronary occlusion (CTO) imaging

Another provided record describes a study in patients with chronic total occlusion of a coronary artery (a long-lasting complete blockage of a heart artery).[2]

The main objective was to evaluate how well coronary CT angiography with myocardial perfusion imaging at stress and rest matches (concordance) stress cardiac MRI for detecting ischemia and viability in CTO patients.[2]

In this study record, the drug listed is an IV product containing the active substance THEOPHYLLINE ANHYDROUS (route: intravenous), with a listed maximum daily dose amount of 200 mg and a maximum treatment period of 4 (time unit code provided in the record).[2]

The product name shown is “Eufilina Venosa 200 mg solution for injection.”[2]

Key imaging definitions and endpoints in the CTO study

The study’s primary endpoints include measures of viability, myocardial ischemia, and how CTO is defined and classified.[2]

For viability, one imaging criterion was “late enhancement” in more than 50% of the thickness of the affected myocardial wall using the 17-segment model, reported as the number of segments meeting the criterion.[2]

Another viability criterion looked at mean myocardial thickness less than 5 mm or 3 mm in segments with movement (motility) impairment, also counted by number of segments meeting the criterion.[2]

For myocardial ischemia, the study defined it as an inducible and persistent perfusion defect during stress that significantly improves or resolves at rest and exceeds the extent of myocardial scar in the same segment on late enhancement images, again reported as the number of segments showing ischemia.[2]

The CTO definition was absence of antegrade coronary flow through the coronary stenosis, allowing that there may be collateral flow as long as there is no flow through the lesion.[2]

The study planned to classify CTO as definite if there is evidence the occlusion lasted more than three months, and probable if duration evidence is not available.[2]

Secondary endpoints and methods included baseline cardiac MRI and follow-up at 6 months, CT imaging as part of routine pre-procedural evaluation, adverse event definitions using CTO-ARC, and arrhythmogenic substrate evaluation using late enhancement images and specified software.[2]

Topic What the trials show (based on the provided trial records)
Main drug discussed THEOPHYLLINE ANHYDROUS (oral tablet in one trial; IV solution for injection in another)
Trial setting 1 Randomized, double-blind Phase 4 trial in 60 patients with post-dural puncture headache; compared oral theophylline vs oral sumatriptan
Trial setting 2 Cardiovascular imaging study in chronic total coronary occlusion evaluating agreement between CT-based imaging and stress cardiac MRI for ischemia and viability
Doses/forms in the data Oral: 150 mg every 12 hours (theophylline). IV: up to 200 mg total daily dose listed for the injection product
Key outcomes described Pain scores over 48 hours (NPRS), headache duration (time to NPRS ≤ 3), length of hospital stay, and treatment-related side effects; imaging endpoints for ischemia, viability, and CTO definition in the imaging study

FAQ

  • What is THEOPHYLLINE ANHYDROUS in these clinical trials? In the trials described here, THEOPHYLLINE ANHYDROUS was used either as an oral tablet (150 mg every 12 hours) for post-dural puncture headache, or as an intravenous injection product (up to 200 mg) used within a cardiovascular imaging study.
  • What condition was treated with oral theophylline in the randomized trial? Oral theophylline was studied for treating post-dural puncture headache, which is a common complication after procedures that puncture the dura (the covering around the spinal cord), such as spinal anesthesia or an accidental puncture during epidural anesthesia.
  • What was theophylline compared to in the headache trial? The headache trial compared oral theophylline to oral sumatriptan. Both were active treatments, and patients were randomly assigned to one of the two groups.
  • How did the headache trial measure whether treatment worked? The trial measured headache severity using the Numeric Pain Rating Scale (NPRS), a 0–10 scale where 0 means no pain and 10 means the worst possible pain. Pain scores were checked before treatment and then repeatedly up to 48 hours.
  • Why was THEOPHYLLINE ANHYDROUS used in the coronary chronic total occlusion imaging study? In that study, theophylline anhydrous (given intravenously) was listed as a drug used within a multimodality imaging evaluation designed to compare different imaging methods for detecting myocardial ischemia (reduced blood flow to heart muscle) and viability (whether heart muscle tissue is still alive and potentially recoverable).

Ongoing Clinical Trials on THEOPHYLLINE ANHYDROUS

  • Study on Theophylline, Gadoteric Acid, and Regadenoson for Patients with Chronic Total Coronary Artery Blockage

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

Glossary

  • THEOPHYLLINE ANHYDROUS: A form of theophylline without water in its chemical structure. In these trials it was used as an oral tablet for headache after dural puncture and as an intravenous (IV) injection product in a heart imaging study.
  • Quibron-T/SR tablets: An “other name” listed for the oral theophylline anhydrous tablet in the post-dural puncture headache trial.
  • Post-dural puncture headache (PDPH): A headache that can occur after the dura (a protective covering around the spinal cord) is punctured, such as during spinal anesthesia or an accidental puncture during epidural anesthesia.
  • Dural puncture: A puncture (small hole) in the dura. This can happen intentionally in spinal anesthesia or accidentally during epidural anesthesia procedures.
  • Spinal anesthesia: A type of anesthesia (numbing) given near the spinal cord. The trial background notes PDPH can occur after procedures associated with dural puncture for spinal anesthesia.
  • Epidural anesthesia: A type of anesthesia given near the spine. The trial background notes PDPH can occur after accidental dural puncture during epidural anesthesia.
  • Prospective study: A study that follows patients forward in time from the start of treatment to observe outcomes (for example, pain scores over 48 hours).
  • Randomized clinical trial: A trial where participants are assigned by chance to different treatment groups (for example, theophylline group vs sumatriptan group).
  • Double-blind: A study design where participants and the study team do not know which treatment each participant receives, helping reduce bias.
  • Phase four (Phase 4) trial: A later-stage clinical trial phase often done to evaluate safety and effectiveness in real-world use after a treatment is already in use.
  • Active comparator: A comparison group that receives another active treatment (not a placebo). In the PDPH trial, theophylline was compared with sumatriptan.
  • Sumatriptan succinate: A drug used as the comparator treatment in the PDPH trial, given as an oral tablet (25 mg every 12 hours).
  • Numeric Pain Rating Scale (NPRS): A pain scale from 0 to 10 used to rate pain severity. In the PDPH trial, 0 meant no pain and 10 meant the worst possible pain, measured multiple times up to 48 hours.
  • PDPH duration: In the PDPH trial, the time from when the headache started until the NPRS pain score became 3 or less.
  • Treatment-related side effects: Unwanted symptoms monitored during treatment. In the PDPH trial these included palpitation, dizziness, gastric irritation, nausea/vomiting, diarrhea, warm sensations, tingling sensation, and tightness in the chest, throat, neck, or jaws.
  • Palpitation: A sensation of fast, strong, or irregular heartbeats. It was listed as a side effect monitored in the PDPH trial.
  • Gastric irritation: Stomach discomfort or irritation. It was listed as a side effect monitored in the PDPH trial.
  • Chronic total occlusion (CTO): A long-lasting complete blockage of a coronary (heart) artery. The study defined CTO as absence of forward (antegrade) blood flow through the coronary narrowing, and considered it “definite” if lasting more than three months.
  • Coronary CT angiography: A CT (computed tomography) imaging method used to look at coronary arteries. In the CTO study it was part of an imaging comparison approach.
  • Myocardial perfusion imaging (stress and rest): Imaging that checks blood flow to the heart muscle during “stress” and at “rest.” In the CTO study, it was used to detect ischemia and compared with stress cardiac MRI.
  • Stress cardiac MRI (CMR): A heart MRI test performed under stress conditions to help find areas with reduced blood flow (ischemia). The CTO study compared stress CMR with CT-based approaches.
  • Ischemia: Reduced blood flow and oxygen delivery to tissue. In the CTO study, ischemia was assessed by looking for a perfusion defect during stress that improves or resolves at rest.
  • Viability: Whether heart muscle tissue is still alive and potentially able to recover. The CTO study evaluated viability using imaging criteria such as late enhancement and myocardial thickness.
  • Late enhancement: An imaging finding used in the CTO study’s viability criteria, described as enhancement in more than 50% of the thickness of the affected heart wall segment.
  • 17-segment model: A standardized way to divide the heart muscle into 17 segments for reporting imaging findings, used in the CTO study’s viability assessment.
  • Myocardial thickness criterion: A viability-related imaging criterion in the CTO study that looked at very thin heart muscle (for example, mean thickness less than 5 mm or 3 mm) in segments with movement problems.
  • Percutaneous revascularization: A catheter-based procedure to restore blood flow in a blocked artery. The CTO study discussed imaging before and after percutaneous revascularization.
  • Arrhythmogenic substrate: Heart tissue features that can contribute to abnormal heart rhythms. The CTO study planned to evaluate this using cardiac MRI imaging (including scar and ischemia characterization).
  • Intravenous (IV) route: Giving a drug directly into a vein. In the CTO study, theophylline anhydrous was listed as a solution for injection given intravenously.
  • Eufilina Venosa 200 mg solution for injection: The product name listed in the CTO study for an IV theophylline anhydrous medication.
  • Informed consent: A process where a participant agrees to join a study after being informed about what it involves. The CTO study included the ability to provide informed consent as an inclusion criterion.
  • Dual antiplatelet therapy: Use of two medications that reduce platelet clotting. In the CTO study, having a contraindication (reason it cannot be used safely) was an exclusion criterion.
  • Glomerular filtration rate (GFR): A measure of kidney function. In the CTO study, severe chronic kidney impairment was defined as GFR ≤ 30 mL/min and was an exclusion criterion.

References