Health Condition 1: K868- Other specified diseases of pancreas
Conditions
Interventions
Intervention1: Pancreatin enteric-coated capsule 10000 U lipase: Amylase 8000 (Ph.Eur.U)/U
Lipase 10000 (Ph.Eur.U)/U
Protease 600 (Ph.Eur.U)/U
Route of administration: Pancreatin capsule ââ?¬â? Oral
Sponsors
Abbott India Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Patients meeting all the following criteria are eligible for participation in the study: 1. Male or female adult patients aged 18 years to 65 years. 2. Known case of T2DM with confirmed diagnosis of PEI based on clinical and biochemical assessment (meeting both of following criteria) a. Biochemical diagnosis will be based on criteria with patients meeting FE-1 values less than 200 �¼g/g. b. Symptomatic diagnosis will be based on presence of any of the following symptoms: steatorrhea, abdominal pain, weight loss, diarrhea, bloating, and foul-smelling and greasy stools. 3. Patient prescribed Pancreatin enteric-coated capsule as per approved label. 4. Patient willing to give written informed consent to participate into the study. 5. Willing to take the study drug as prescribed by the investigator. 6. Willing to comply with the protocol requirements.
Exclusion criteria
Exclusion criteria: A patient will be excluded from the study if they meet any of the following criteria: 1. Patients requiring hospitalization due to severe nature of disease. 2. Patients with severe cardiac, renal or hepatic disease 3. Malignancy involving the digestive tract in the past 5 years 4. Patients who have recently undergone major surgery (excluding appendectomy or gall-bladder removal). 5. Contraindications to PERT treatment, including hypersensitivity to active substance, porcine proteins, pancreatin or any ingredient. 6. Use of any PERT within 30 days prior to study enrollment 7. Women of childbearing potential with a positive urine pregnancy test during screening or unwillingness to use an effective form of birth control during the study. 8. Any condition or unsuitable reasons that in the opinion of the investigator does not justify the patientââ?¬•s inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in mean abdominal symptom score on the PEI-Q will be summarized at Day 30 using descriptive measures as well as 95 percent CI of the mean. A paired t-test (if data normal) or Wilcoxon signed-rank test will be performed at the 5 percent level to assess the significance of the change from baselineTimepoint: 30 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| The change in mean abdominal symptom score at Day 15 and change in mean bowel movement symptom score on the PEI-Q at Days 15 and 30 will be analyzed in the same manner as the primary endpoint.Timepoint: 30 Days | — |
Countries
India
Contacts
Public ContactDr Shivani Acharya
Abbott India Ltd
Outcome results
None listed