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Topical Metronidazole for Pain After Haemorrhoidectomy
NCT00774722Phase 3
Key facts
- Status
- Completed
- Start
- Sep 2006
- Primary completion
- Mar 2008
- Countries
- 1
- Sponsor
- SLA Pharma
- Modality
- Small Molecules
- Drugs
- metronidazole
- Conditions
- postoperative pain
01
Overview
Phase 3, randomised, double-blind trial in postoperative pain comparing Metronidazole with Placebo (2 arms). Primary endpoint: Reduction of post-operative pain associated with haemorrhoidectomy at 14 days. Started Sep 2006; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Metronidazole
10% Metronidazole ointment
Placebo
Placebo ointment
03
Who it enrols
Adult patients with Grade 3 or 4 haemorrhoids scheduled for diathermy haemorroidectomy, medically fit for surgery, and not suffering from chronic pain requiring narcotics.
04
Endpoints
Primary
Reduction of post-operative pain associated with haemorrhoidectomy
Secondary
Expected pain following haemorrhoidectomy
Overall patient satisfaction with the operation
Number of analgesics required post-operatively
Time taken to return to work
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