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NCT04257851
Is Theophylline More Effective Than Sumatriptan in the Treatment of Post-dural Puncture Headache
Phase 4 trial testing Theophylline Anhydrous Oral Tablet in Post-Dural Puncture Headache in 60 participants. Completed in 15 May 2021.
15 May 2021
Quick facts
| Lead sponsor | Damanhour Teaching Hospital |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 15 February 2020 |
| Primary completion | 15 May 2021 |
| Estimated completion | 15 May 2021 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Theophylline Anhydrous Oral Tablet — full drug profile →
- Sumatriptan Succinate Oral Tablet — full drug profile →
Conditions studied
- Post-Dural Puncture Headache — all drugs for Post-Dural Puncture Headache →
Sponsor
Damanhour Teaching Hospital
Who can join
Adults 21 to 50, any sex, with Post-Dural Puncture Headache. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Objectives: To compare the safety and efficacy of oral theophylline versus oral sumatriptan in the treatment of post-dural puncture headache (PDPH). Background: PDPH is the most frequent complication of procedures associated with dural puncture for spinal anesthesia or following accidental dural puncture during epidural anesthesia. Since invasive treatments have known complications, pharmacologic management may be preferable. Patients and Methods: This was a prospective, randomized, double-blind, phase four clinical trial; carried out on 60 patients presented with PDPH at our hospital. Patients were randomly allocated into two equal groups (30 patients each); group T, received oral theophylline, and group S, received oral sumatriptan.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04257851
- Europe PMC full search
- ASCO Meeting Library
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- bioRxiv preprints
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Related trials
Other recruiting trials for Post-Dural Puncture Headache
Currently open trials in the same condition.
- NCT06824025 — Comparison of Nebulized Neostigmine/Atropine Versus Lignocaine in Treating Acute Post-dural Puncture Headache Following · EARLY_PHASE1 · recruiting
- NCT07515456 — Theophylline, Versus Sumatriptan and Gabapentin in The Treatment of Post-Dural Puncture Headache · NA · recruiting
- NCT06253754 — Pathophysiological Mechanisms and Implication of Treatment in Postural Puncture Headache · recruiting
- NCT06444737 — Contribution of Ondansetron to Preventing Post-Dural Puncture Headaches Following Spinal Anesthesia · NA · recruiting
- NCT05804448 — Effect of Altitude on Postdural Puncture Headache After Caesarean Delivery · recruiting
Other Damanhour Teaching Hospital trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04257851 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Damanhour Teaching Hospital
- Last refreshed: 3 June 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04257851.
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