Evaluation of efficacy and safety of aceclofenac injection in the treatment of acute lumbago: a randomised comparative open-labeled multi-centric trial
| ISRCTN | ISRCTN99850066 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99850066 |
| Secondary identifying numbers | ACELO-0605 |
- Submission date
- 19/09/2006
- Registration date
- 03/10/2006
- Last edited
- 04/10/2006
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr V P Pandey
Scientific
Scientific
A-4, MIG
A.B.Road
Indore
Madhya Pradesh
452001
India
| Phone | +91 0731 2532164 |
|---|---|
| vppandey@sancharnet.in |
Study information
| Study design | Two arm, open-labeled, multi-centric, randomised, comparative trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | To evaluate the efficacy and tolerability of aceclofenac injection as compared to diclofenac injection in subjects suffering from acute lumago. |
| Ethics approval(s) | Institutional Ethic Committee approval taken for the study. |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Aceclofenac |
| Primary outcome measure | 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 study start date | 02/05/2006 |
| Completion date | 10/08/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 300 |
| Key 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) |
| Key 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) |
| Date of first enrolment | 02/05/2006 |
| Date of final enrolment | 10/08/2006 |
Locations
Countries of recruitment
- India
Study participating centre
A-4, MIG
Madhya Pradesh
452001
India
452001
India
Sponsor information
Venus Remedies Limited (India)
Industry
Industry
Intellectual Scientific Division
Research and Development Centre
51-52 Industrial Area
Phase-1
Panchkula
Haryana
134113
India
| Phone | +91 17 22561244 |
|---|---|
| operations@venusremedies.com | |
| Website | http://www.venusremedies.com |
"ROR" |
https://ror.org/0169rv113 |
Funders
Funder type
Industry
Venus Remedies Limited (India)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
