observational, Phase-IV Clinical Study to Evaluate Safety data, Tolerability and Efficacy of Injection of Fixed-dose Combination of Camylofin Dihydrochloride 25 mg and Diclofenac Sodium IP 25 mg per ml with Benzyl alcohol IP in the treatment of Colic(Severe Abdominal Pain)
- Conditions
- Health Condition 1: K812- Acute cholecystitis with chronic cholecystitis
- Registration Number
- CTRI/2018/06/014463
- Lead Sponsor
- Cliniexperts Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
1. Subject in group of 18-65 years(age of ascent)
2. Written and/or witnessed informed consent to participate in the trial was taken prior to initiating the study from parent and/or legally accepted representative
3.Patients who had at least six months previous history of confirmed diagnosis of colic
1. Not willing to sign ICF
2. Patients Known or thought to be hypersensitivity, to study drug
3. Pregnant and lactating women
4. patient with history of hypersensitivity to Camylofin or Diclofenac Sodium
5. Patient with prostatic hypertrophy
6. Patients with glaucoma
7. Patient with mechanical stenosis
8. Patients with serious underlying organic disorders
9. Patients with paralytic ileus
10. Patient with renal and hepatic disorder
11. Patient with previous history of heart problems and stroke.
12. Participation in another clinical trial in last months and doing study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary StudyObjective <br/ ><br>The primary objective of this trial is to evaluate safety & tolerability of the FDC in <br/ ><br>treatment ofColic <br/ ><br>Secondary Study Objective <br/ ><br>Thesecondaryobjectiveofthis trialis toevaluateefficacyofthis FDCintreatmentofColic. <br/ ><br> <br/ ><br>Timepoint: 1 hour 3 hours and 24 hours <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method Secondary Study Objective <br/ ><br>The secondary objective of this trial is to evaluate efficacy of thisTimepoint: 1 hour 3 hours and 24 hours