E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Capsulitis of the Shoulder |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001286 |
E.1.2 | Term | Adhesive capsulitis of shoulder |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine if repeated injections are more effective than a single injection in the treatment of shoulder “capsulitis”. |
|
E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Adult subjects (>= 18 years) with unilateral shoulder pain of more than 4 weeks duration and a SPADI score of >= 30 as this represents significant disability. Shoulder pain is defined as pain in the shoulder region, including the upper arm, elicited by shoulder movement. “Capsulitis” is defined by finding of limitation of passive range of movement of greater than 25% in both external rotation and abduction as compared with the contra-lateral shoulder with relatively more restriction in external rotation than abduction and internal rotation. |
|
E.4 | Principal exclusion criteria |
• Physiotherapy or injection treatment for current shoulder pain in previous 3 months • inability to give informed consent • blood coagulation disorders • bilateral shoulder pain • abnormal shoulder X-ray defined as significant glenohumeral or subacromial joint space narrowing suggesting OA of glenohumeral joint or complete RC rupture, • evidence of rotator cuff tear, tested by external rotation lag sign, drop sign, internal rotation lag sign and static muscle resistance in external rotation, internal rotation and abduction, • history of significant trauma to the shoulder, • inflammatory joint disease, • history of cerebrovascular accident, • allergy or contraindication to Triamcinolone/contraindication to injection. • evidence of referred pain from cervical spine disease. • pregnancy or breast feeding |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Shoulder Pain and Disability Index (SPADI) has been shown to be a reliable and valid outcome measure. The SPADI at 26 weeks will be considered the primary end point. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |