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Clinical Trials/CTRI/2010/091/001368
CTRI/2010/091/001368
Completed
Phase 3

A randomized, open label, comparative, multicentric study to assess the efficacy and safety of Acrivastine capsules in comparison with Chlorpheniramine maleate tablets in patients suffering from allergic rhinitis

Cadila Healthcare Ltd5 sites in 1 country200 target enrollmentStarted: September 15, 2010Last updated:
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Overview

Phase
Phase 3
Status
Completed
Enrollment
200
Locations
5
Primary Endpoint
The change in the total symptom score
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

This study is an open label, comparative, multicentric study comparing the safety and efficacy of Acrivastine 8 mg capsules and Chlorpheniramine maleate 4 mg tablets given thrice daily each for 2 weeks; in 200 patients with allergic rhinitis that will be conducted in India. The primary outcome measures will be the change in total symptom score of nasal and ocular symptoms during the course of study.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Open Label

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •1.Patients of either sex of 18 to 65 years of age 2.Established diagnosis of allergic rhinitis 3.Informed consent.

Exclusion Criteria

  • •1.Pregnancy & Lactation.2.Significant renal impairment.3.Narrow-angle glaucoma, GI or GUT obstruction.4.Patients with acute attack of bronchial asthma or those on corticosteroids.5.Nasal structural abnormalities6.Upper respiratory tract infection7.Hypersensitivity to study medications8.Patients with any other serious concurrent illness or malignancy9.Continuing history of alcohol and / or drug abuse10.Recent participation in another clinical trial.

Outcomes

Primary Outcomes

The change in the total symptom score

Time Frame: 0,1,2 weeks

Secondary Outcomes

  • The change in the total and individual nasal and ocular symptom scores(0,1,2 weeks)

Investigators

Sponsor Class
Pharmaceutical industry-Indian

Study Sites (5)

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