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NCT00753064
Comparative Study of Efficacy of Antiscorpion Venom Serum(AScVS)vs Prazosin in the Management of Severe Scorpion(Mesobuthus Tamulus Concanesis Pocock)Envenomation and Evaluation of Effects of the Combination of AScVS + Prazosin Therapy.
Phase 3 trial testing Antiscorpion venom serum(AScVS). in Scorpion Envenomation in 81 participants. Completed in 1 December 2007.
1 December 2007
Quick facts
| Lead sponsor | Haffkine Bio-Pharmaceutical Corporation Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 81 |
| Start date | 1 September 2006 |
| Primary completion | 1 December 2007 |
| Estimated completion | 1 December 2007 |
| Sites | 5 locations across India |
Drugs / interventions tested
- Antiscorpion venom serum(AScVS). — full drug profile →
- T.Prazosin — full drug profile →
- AScVS + Prazosin — full drug profile →
Conditions studied
- Scorpion Envenomation — all drugs for Scorpion Envenomation →
Sponsor
Haffkine Bio-Pharmaceutical Corporation Ltd. — full company profile →
Who can join
Adults 12 to 65, any sex, with Scorpion Envenomation. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Superiority of AScVS and AScVS+Prazosin was confirmed over use of Prazosin alone.
Time frame: 1year 4 months.
Sponsor's own description
The data available for the efficacy of AScVS and prazosin is generated through different trials done in different clinical setting. Hence it was felt worthwhile to confirm the documented efficacy of AScVS and prazosin in terms of time taken for clinical recovery in a clinical trial. Along with this, effects of both the therapies on various biochemical parameters will be recorded and compared with. It was also felt necessary to study the effect of combination on the clinical outcome.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Related trials
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 NCT00753064 (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 Haffkine Bio-Pharmaceutical Corporation Ltd.
- Last refreshed: 15 September 2008
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/NCT00753064.
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