Post-dural Puncture HeadachePhase 3NCT02522013
Aminophylline for Patients With Post-Dural Puncture Headache
A Phase 3 study testing Aminophylline and isotonic saline in people with Post-dural Puncture Headache, run by The First Affiliated Hospital of Zhengzhou University at 4 sites in China.
Trial summary
Post-dural puncture headache (PDPH) is the most common complication of lumbar puncture. Its clinical manifestations are pain in the forehead and the occipital region, or diffuse headache. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Post-dural Puncture Headache
- What is being tested?
- Aminophylline and isotonic saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 4 sitesChina
- Study dates
- Oct 2015to Oct 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- headache has developed after the dural puncture;
- PDPH was defined according to the International Classification of Headache Disorders III (ICHD-3) criteria;
- The VAS score of the headache was 5 or more than 5;
- age between 18 and 70 years old.
Who cannot join
- a previous history of headache that could interfere with PDPH diagnosis;
- a history of central nervous system diseases including intracranial hemorrhage, seizures, intracranial hypertension, and hydrocephalus;
- a history of cardiovascular system diseases including coronary heart disease, arrhythmias, and hypertension;
- a history of peptic ulcer.
- women who were pregnant, nursing, or planning a pregnancy.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Jinzhou central hospital
Jinzhou, Liaoning
the second hospital of Hebei medcial university
Shijiazhuang, Hebei
Suzhou municipal hospital
Suzhou, Anhui
Henan Province Hospital of Traditional Chinese Medicine
Zhengzhou, Henan
About this study
Official title: Aminophylline for Patients With Post-Dural Puncture Headache: a Prospective, Multi-center, Randomized Controlled Trial
Post-dural puncture headache (PDPH) is the most common complication of lumbar puncture. Its clinical manifestations are pain in the forehead and the occipital region, or diffuse headache. The pain is dull or fluctuating, becoming worse when standing and better when lying down, and is often accompanied by symptoms including a stiff neck, tinnitus, hearing loss, photophobia, and nausea, which cause great suffering to the patients1. According to epidemiological data, approximately 10% to 30% of the patients who undergo lumbar puncture suffer from PDPH within 48 hours of the procedure.Currently, commonly used treatments for PDPH include rehydration, the administration of corticotropin, caffeine, or sumatriptan, and the application of an epidural blood patch. The efficacy of theophylline has been proven in a placebo-controlled study in which 17 PDPH patients received an intravenous (IV) injection of 200 mg theophylline. The Visual Analogic Scale scores 4 hours after treatment were significantly different compared with those of the placebo group5. At present, the clinical application of theophylline has been replaced by aminophylline and doxofylline, and it is difficult to purchase theophylline in most hospitals in China and other countries.
The Aminophylline for Patients With Post-Dural Puncture Headache trial, is a prospective,randomized,double-blind,placebo-controlled trial to evaluate the efficacy and safety of an IV injection of aminophylline on post-dural puncture headache.Eligible patients were randomized in a blinded fashion(1:1) to receive IV injection of aminophyllineor or sterile isotonic saline.The investigators estimate that this trial will demonstrate that an IV injection of aminophylline could be the preferred method for the clinical treatment of PDPH.
- Conditions
- Post-dural Puncture Headache
- Being tested
- Aminophylline, isotonic saline
- Keywords
- post-dural puncture headache, Aminophylline
- Medical subject headings
- Post-Dural Puncture Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AminophyllineDrug
isotonic salineDrug
| Study group | Role | What they receive |
|---|---|---|
| Aminophylline group | Experimental | IV injection of aminophylline Receives: Drug: Aminophylline |
| isotonic saline group | Placebo comparator | IV injection of isotonic saline group Receives: Drug: isotonic saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain on the Visual Analogue Scale
Measured: baseline phase
pain on the Visual Analogue Scale
Measured: 0.5 hour after the Intervention
pain on the Visual Analogue Scale
Measured: 1 hour after the Intervention
pain on the Visual Analogue Scale
Measured: 8 hours after the Intervention
pain on the Visual Analogue Scale
Measured: 1 day after the Intervention
pain on the Visual Analogue Scale
Measured: 2 days after the Intervention
Secondary outcomes (1)
the overall response to treatment on the Patient Global Impression of Change
Measured: 2 days after the Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Post-dural Puncture HeadacheStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Zhengzhou UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chuanjie Wu, The First Affiliated Hospital of Zhengzhou University
- Investigators
- Fang Xue, MD, Principal investigator, the second hospital of Hebei medcial universityDongsheng Guan, MD, Principal investigator, The Second Affiliated Hospital of Henan University of Traditional Chinese MedicineChangming Wan, MD, Principal investigator, Jingzhou Central HospitalZhengfei Ma, MD, Principal investigator, Suzhou Municipal Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02522013
- Sponsor's protocol ID
- FAHZZU-166
- Status last verified
- Oct 2016
- First submitted
- 8 Aug 2015
- Last updated
- 31 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Feuerstein TJ, Zeides A. Theophylline relieves headache following lumbar puncture. Placebo-controlled, double-blind pilot study. Klin Wochenschr. 1986 Mar 3;64(5):216-8. doi: 10.1007/BF01711650.
PubMed 3517473Arroyo-Quiroz C, Kurth T, Cantu-Brito C, Lopez-Ridaura R, Romieu I, Lajous M. Lifetime prevalence and underdiagnosis of migraine in a population sample of Mexican women. Cephalalgia. 2014 Nov;34(13):1088-92. doi: 10.1177/0333102414529196. Epub 2014 Apr 7.
PubMed 24711606Mills MD, Hogstrom KR, Fields RS. Determination of electron beam output factors for a 20-MeV linear accelerator. Med Phys. 1985 Jul-Aug;12(4):473-6. doi: 10.1118/1.595674.
PubMed 3929052Hayallah AK, Talhouni AA, Alim AA. Design and synthesis of new 8-anilide theophylline derivatives as bronchodilators and antibacterial agents. Arch Pharm Res. 2012 Aug;35(8):1355-68. doi: 10.1007/s12272-012-0805-4. Epub 2012 Sep 1.
PubMed 22941478Wu C, Guan D, Ren M, Ma Z, Wan C, Cui Y, Zhong P, Zhao W, Li C, Yan F, Xie J, Xue F, Lian Y, Liu H, Wang C, Ji X, Xie N. Aminophylline for treatment of postdural puncture headache: A randomized clinical trial. Neurology. 2018 Apr 24;90(17):e1523-e1529. doi: 10.1212/WNL.0000000000005351. Epub 2018 Mar 23.
PubMed 29572284
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aminophylline for Patients With Post-Dural Puncture Headache: a Prospective, Multi-center, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02522013
- Acronym / sponsor ID
- FAHZZU-166
- Conditions
- Post-dural Puncture Headache
- Keywords
- post-dural puncture headache, Aminophylline
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 13 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Post-dural puncture headache (PDPH) is the most common complication of lumbar puncture. Its clinical manifestations are pain in the forehead and the occipital region, or diffuse headache. The pain is dull or fluctuating, becoming worse when standing and better when lying down, and is often accompanied by symptoms including a stiff neck, tinnitus, hearing loss, photophobia, and nausea, which cause great suffering to the patients1. According to epidemiological data, approximately 10% to 30% of the patients who undergo lumbar puncture suffer from PDPH within 48 hours of the procedure.Currently, commonly used treatments for PDPH include rehydration, the administration of corticotropin, caffeine, or sumatriptan, and the application of an epidural blood patch. The efficacy of theophylline has been proven in a placebo-controlled study in which 17 PDPH patients received an intravenous (IV) injection of 200 mg theophylline. The Visual Analogic Scale scores 4 hours after treatment were significantly different compared with those of the placebo group5. At present, the clinical application of theophylline has been replaced by aminophylline and doxofylline, and it is difficult to purchase theophylline in most hospitals in China and other countries.
The Aminophylline for Patients With Post-Dural Puncture Headache trial, is a prospective,randomized,double-blind,placebo-controlled trial to evaluate the efficacy and safety of an IV injection of aminophylline on post-dural puncture headache.Eligible patients were randomized in a blinded fashion(1:1) to receive IV injection of aminophyllineor or sterile isotonic saline.The investigators estimate that this trial will demonstrate that an IV injection of aminophylline could be the preferred method for the clinical treatment of PDPH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aminophylline group | Experimental | Drug: AminophyllineIV injection of aminophylline |
| isotonic saline group | Placebo comparator | Drug: isotonic salineIV injection of isotonic saline group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- headache has developed after the dural puncture;
- PDPH was defined according to the International Classification of Headache Disorders III (ICHD-3) criteria;
- The VAS score of the headache was 5 or more than 5;
- age between 18 and 70 years old.
Key exclusion criteria (5 listed)
- a previous history of headache that could interfere with PDPH diagnosis;
- a history of central nervous system diseases including intracranial hemorrhage, seizures, intracranial hypertension, and hydrocephalus;
- a history of cardiovascular system diseases including coronary heart disease, arrhythmias, and hypertension;
- a history of peptic ulcer.
- women who were pregnant, nursing, or planning a pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aminophylline | Drug | Aminophylline group |
| isotonic saline | Drug | isotonic saline group |
Primary outcome
pain on the Visual Analogue Scale
Time frame: baseline phase
pain on the Visual Analogue Scale
Time frame: 0.5 hour after the Intervention
pain on the Visual Analogue Scale
Time frame: 1 hour after the Intervention
pain on the Visual Analogue Scale
Time frame: 8 hours after the Intervention
pain on the Visual Analogue Scale
Time frame: 1 day after the Intervention
pain on the Visual Analogue Scale
Time frame: 2 days after the Intervention
1 secondary outcome
the overall response to treatment on the Patient Global Impression of Change
Time frame: 2 days after the Intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2016.
- Results publication: PubMed 3517473Feuerstein TJ, Zeides A. Theophylline relieves headache following lumbar puncture. Placebo-controlled, double-blind pilot study. Klin Wochenschr. 1986 Mar 3;64(5):216-8. doi: 10.1007/BF01711650.
- Results publication: PubMed 24711606Arroyo-Quiroz C, Kurth T, Cantu-Brito C, Lopez-Ridaura R, Romieu I, Lajous M. Lifetime prevalence and underdiagnosis of migraine in a population sample of Mexican women. Cephalalgia. 2014 Nov;34(13):1088-92. doi: 10.1177/0333102414529196. Epub 2014 Apr 7.
- Results publication: PubMed 3929052Mills MD, Hogstrom KR, Fields RS. Determination of electron beam output factors for a 20-MeV linear accelerator. Med Phys. 1985 Jul-Aug;12(4):473-6. doi: 10.1118/1.595674.
- Results publication: PubMed 22941478Hayallah AK, Talhouni AA, Alim AA. Design and synthesis of new 8-anilide theophylline derivatives as bronchodilators and antibacterial agents. Arch Pharm Res. 2012 Aug;35(8):1355-68. doi: 10.1007/s12272-012-0805-4. Epub 2012 Sep 1.
- Derived from this study: PubMed 29572284Wu C, Guan D, Ren M, Ma Z, Wan C, Cui Y, Zhong P, Zhao W, Li C, Yan F, Xie J, Xue F, Lian Y, Liu H, Wang C, Ji X, Xie N. Aminophylline for treatment of postdural puncture headache: A randomized clinical trial. Neurology. 2018 Apr 24;90(17):e1523-e1529. doi: 10.1212/WNL.0000000000005351. Epub 2018 Mar 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fang Xue, MD principal investigator
the second hospital of Hebei medcial university
Dongsheng Guan, MD principal investigator
The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine
Changming Wan, MD principal investigator
Jingzhou Central Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aminophylline and isotonic saline in people with Post-dural Puncture Headache, run by The First Affiliated Hospital of Zhengzhou University at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain on the Visual Analogue Scale (time frame: baseline phase). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02522013, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2016.