Health Condition 1: null- Patients suffering from severe acute spasmodic pain due to dysmenorrhea or renal or ureteric colic or biliary colic or intestinal and other abdominal colic
Conditions
Interventions
Intervention1: Spasmoproxyvon Plus capsules: Fixed dose combination of Tramadol 50mg and Dicyclomine 10mg and Acetaminophen 325mg of Wockhardt limited
Control Intervention1: NIL: NIL
Sponsors
Wockhardt Limited
Eligibility
Inclusion criteria
Inclusion criteria: Subject should meet all of the below mentioned inclusion criteria for enrollment, 1. Patients of either sex aged between 18 to 65 years (inclusive) 2. Patients clinically diagnosed with severe acute spasmodic colicky pain (pain score = 70 on VAS) due to dysmenorrhea, renal/ureteric colic, biliary colic, intestinal and other abdominal colic. 3. Subjects who understand the nature of trial and provide written informed consent for the trial 4. Subjects who are willing to comply with protocol procedures
Exclusion criteria
Exclusion criteria: Subjects will not be eligible for enrollment in the study if a subject meets any of the following criteria, 1. Patients with known hypersensitivity to any of the content of study medication i.e., Tramadol or dicyclomine and paracetamol. 2. Patients who have taken an antispasmodic agent within 7 days before enrollment in the study. 3. Patients with history of pathological conditions of the intestine including inflammatory bowel disease or malabsorption syndromes or gastrointestinal malignancy or gastric or intestinal surgery including vagotomy or Barretts esophagus or scleroderma confirmed by endoscopic Gastric mucosal biopsy specimens for ulcers. 4. Patients with signs of significant or massive GI bleeding. 5. Patients with severe renal disorder. 6. Patients with a history of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis. 7. Patient with history of glaucoma and Myasthenia 8. Patient with history of acute pancreatitis and biliary disorder other than colicky pain 9. Patient with history of any other psychiatric or other chronic diseases that will prevent compliance with the study protocol. 10. Patient with history of asthma and patients with risk of respiratory depression. 11. History or evidence of significant cardiovascular disease, any malignancy, thyroid dysfunction, epilepsy, alcohol or drug abuse or any other medical condition that in the opinion of Investigator can interfere with the study treatment. 12. Women of child-bearing potential who are pregnant or lactating or not following adequate contraceptive measures. 13. Patients who are otherwise judged inappropriate for inclusion in the study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety assessments including adverse events (AEs) and serious adverse events (SAEs).Timepoint: safety assessment would be done at the end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean Change in VAS from baseline to end of treatment, Proportion of patients showing = 50% improvement in baseline VAS pain score over end of treatment, Onset of analgesia, Duration of analgesia, Time required for analgesia, No. of study medication consumed to achieve analgesia, Physician’s and patient’s global evaluation, No. of rescue medication usedTimepoint: The assessment would be done at end of the study treatment | — |
Countries
India
Contacts
Public ContactDr Kaushal Kapadia
Wockhardt Ltd.
Outcome results
None listed