Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ketotifen · 1 trial · 1 indication
"Since beginning treatment, how would you describe the change (if any) in ACTIVITY LIMITATIONS, SYMPTOMS, EMOTIONS and OVERALL QUALITY OF LIFE related to your painful condition?" (CHOOSE ONE). * No change (or condition has got worse) * Almost the same, hardly any change at all * A little better, but not noticeable change at all * Somewhat better, but the change has not made any real difference * Moderately better, and a slight but noticeable change * Better, and a definite improvement that has made a real and worthwhile difference * A great deal better, and a considerable improvement that has made all the difference Patients scoring either 6 or 7 on the PGIC scale are categorized as "improved". Patients scoring either 6 or 7 on the PGIC scale are categorized as "improved". We will use this definition as a dichotomous variable.
| Arm | Type | Description |
|---|---|---|
| KF group | EXPERIMENTAL | In each study visit, patients will receive enough pills for the next month. At the first visit, patients receiving ketotifen (KF) will receive four vials sequentially numbered (1 to 4) containing enough pills for one week each, and will be instructed by the clinician and by the pharmacist to use vial 1 for the first week (0.5 mg of KF BDI), vial 2 for the second week (1mg of KF BDI), vial 3 for the third week (2 mg of KF BDI), and vial 4 for the fourth week (3mg of KF BDI). As for weeks 4, 8 and 12 visits, patients treated with KF will receive four equal vials containing enough pills for one week each (3 mg of KF BDI) |
| Placebo group | PLACEBO_COMPARATOR | Patients participating in the placebo group will also receive sequentially numbered vials at the first visit. Similarly, patients taking placebo will also receive four equal vials of pills on the next visits. |
| SOC | ACTIVE_COMPARATOR | Standard of care - patients who refuse to participate in the study but allow us to compare their clinical data to that of participants of the study |
| Name | Type | Description |
|---|---|---|
| Ketotifen Fumarate | DRUG | Ketotifen is a second-generation noncompetitive H1-antihistamine and mast cell stabilizer. It is most commonly sold as a salt with fumaric acid, ketotifen fumarate, and is available in two forms. In its ophthalmic form, it is used to treat allergic conjunctivitis, or the itchy red eyes caused by allergies. In its oral form, it is used to prevent asthma attacks. |
| Placebo | DRUG | - |
| Standard of Care | OTHER | - |
Inclusion Criteria: * Female and male adolescents aged between 14 to 18 years old; * For female adolescents of child bearing potential: negative serum pregnancy test at base line screening; * For female adolescents of child bearing potential: being willing and able to use contraceptive methods for ...