Contact information
Type
Scientific
Primary contact
Dr V P Pandey
ORCID ID
Contact details
A-4
MIG
A.B.Road
Indore
Madhya Pradesh
452001
India
+91 0731 2532164
vppandey@sancharnet.in
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ACELO-0605
Study information
Scientific title
Acronym
Study hypothesis
To evaluate the efficacy and tolerability of aceclofenac injection as compared to diclofenac injection in subjects suffering from acute lumago.
Ethics approval
Institutional Ethic Committee approval taken for the study.
Study design
Two arm, open-labeled, multi-centric, randomised, comparative trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Acute Lumbago
Intervention
Group one - intervention treatment: Aceclofenac injection 150 mg twice daily (b.i.d) for two days.
Group two - intervention treatment: Diclofenac injection 75 mg b.i.d for two days.
Intervention type
Drug
Phase
Not Specified
Drug names
Aceclofenac
Primary outcome measures
1. Assessment of overall response to study drugs.
2. Assessment of overall response of subjects to the drug.
Secondary outcome measures
1. Assessment of changes in VAS pain at 30 minutes, one, two, four, eight, 24 and 48 hours after the treatment compared with the baseline.
2. Assessment to degree of improvement after eight hours, 24 hours and 48 hours of treatment compared to baseline in:
a. pain on movement using a four point scale
b. functional impairment using a four point scale
c. pain on pressure in the lumbosacral region using a four point scale
d. muscle contraction in the lumbosacral region using a four point scale
Overall trial start date
02/05/2006
Overall trial end date
10/08/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients of either sex, aged over 18 years suffering from acute lumbago (that began less than 48 hours before study entry)
2. Pain intensity more than 50 mm on a 100 mm Visual Analogue Scale (VAS)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
300
Participant exclusion criteria
Patients with history of:
1. Recurrent peptic ulcer or duodenal ulcer
2. Gastrointestinal bleeding or other bleeding disorders
3. Significant renal or hepatic impairment
4. Any significant abnormality on preclinical trial screening
5. Pregnant and lactating mothers
6. Patients requiring aspirin at any dose, corticosteroids, anticoagulants, ticlopidine hydrochloride or other drugs affecting platelet function and coagulation, and patients taking hormonal contraceptives or patients allergic to Non Steroidal Anti-Inflammatory Drugs (NSAIDs)
Recruitment start date
02/05/2006
Recruitment end date
10/08/2006
Locations
Countries of recruitment
India
Trial participating centre
A-4, MIG
Madhya Pradesh
452001
India
Sponsor information
Organisation
Venus Remedies Limited (India)
Sponsor details
Intellectual Scientific Division
Research and Development Centre
51-52 Industrial Area
Phase-1
Panchkula
Haryana
134113
India
+91 17 22561244
operations@venusremedies.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Venus Remedies Limited (India)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary